Therapeutic composition for mitigating post-surgical inflammation, scarring and risk of infection and method of administering same
Intravenous administration of B-complex vitamins and essential nutrients addresses the lack of effective post-surgical treatments by reducing inflammation, scarring, and infection risk, promoting healing, and enhancing recovery.
Patent Information
- Application Number
- PCT/US2025/042269
- Authority / Receiving Office
- WO · WO
- Patent Type
- Applications
- Current Assignee / Owner
- Priority Date
- 2024-08-16
- Filing Date
- 2025-08-15
- Publication Date
- 2026-02-19
AI Technical Summary
Current compositions lack the ability to effectively reduce post-surgical inflammation, scarring, and the risk of infection while promoting healing and minimizing pain, particularly in cosmetic and reconstructive surgical procedures.
Aqueous mixtures comprising B-complex vitamins (Thiamine Hydrochloride, Riboflavin 5’ Phosphate Sodium, Pyridoxine Hydrochloride, Dexpanthenol, Niacinamide, Vitamin C, Vitamin B-12, Arginine, L-Glutamine, Biotin, and Zinc) are administered intravenously to mitigate post-surgical complications.
The compositions significantly reduce inflammation, scarring, and infection risk, enhance healing, and improve patient recovery by minimizing pain and discomfort post-surgery.
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Figure US2025042269_19022026_PF_FP_ABST
Abstract
Description
Docket No.: 62795.2WO01THERAPEUTIC COMPOSITION FOR MITIGATING POST-SURGICAL INFLAMMATION, SCARRING AND RISK OF INFECTION AND METHOD OF ADMINISTERING SAMEPejman GolpanianCROSS-REFERENCE TO RELATED APPLICATIONS
[0001] The present application claims priority to U.S. Provisional Pat. Application No. 63 / 683,902, filed August 16, 2024, which is hereby incorporated in its entirety by reference herein.BACKGROUND
[0002] Disclosed are intravenously administered therapeutic compositions (e.g., compositions) that decrease inflammation, reduce the risk of infection, minimize scarring, reduce pain and promote healing, among other benefits, following surgical procedures, and especially following cosmetic and reconstructive surgical procedures. Presently, there is lacking in the art any type of composition that can be administered to prophylactically reduce the pain and discomfort following surgery that likewise can expedite recovery and promote healing. There is further lacking any type of composition that can be given to proactively minimize the scarring that naturally occurs following surgical procedures so as to help achieve an optimal, aesthetically-pleasing outcome as is sought in many cosmetic and reconstructive surgical procedures.SUMMARY
[0003] Provided herein are compositions for mitigating post-surgical inflammation, scarring, and risk of infection comprising an aqueous mixture of a B-complex, wherein the B- Complex comprises: Bl -Thiamine Hydrochloride, B2- Riboflavin 5’ Phosphate Sodium, B6- Pyridoxine Hydrochloride, B5- Dexpanthenol, B3- Niacinamide, Vitamin C; Vitamin B-12, Arginine, L-Glutamine, Biotin, and Zinc. In some embodiments, the B-Complex is present in an amount ranging from 1ml - 30ml, the Vitamin C is present in an amount ranging from 50mg to 30,000mg, the Vitamin B-12 is present as either cyanocobalamin or hydroxocobalamin and present in an amount ranging from 500mcg - 60,000mcg, the Arginine is present in an amount ranging from 50mg - lOgm, the L-Glutamine is present in an amount ranging from lOmg - 20gm, the Biotin is present in an amount ranging from Img - 200mg, and the Zinc is present in an amount ranging from Img - lOOmg. In some embodiments, the Bl -ThiamineDocket No.: 62795.2WO01Hydrochloride is present in an amount of approximately 300mg, the B2- Riboflavin 5’ Phosphate Sodium is present in an amount of approximately 6mg, the B6- Pyridoxine Hydrochloride is present in an amount of approximately 6mg, the B5- Dexpanthenol is present in an amount of approximately 6mg, and the B3- Niacinamide is present in an amount of approximately 300mg. In some embodiments, the Vitamin C is present in an amount of approximately 15OO-3OOOmg, the Vitamin B-12 is present in an amount of approximately 2000- 5000mcg, the Arginine is present in an amount of approximately 100-200mg, the L-Glutamine is present in an amount of approximately 25-50mg, the Biotin is present in an amount of approximately 10-20mg; and the Zinc is present in an amount of approximately 10-20mg. In some embodiments, the composition is mixed with a suitable intravenous carrier.
[0004] Provided herein are methods for mitigating post-surgical inflammation, scarring, and risk of infection comprising intravenously administering a composition comprising: an aqueous mixture of a B-complex, where the B-Complex comprises: Bl -Thiamine Hydrochloride, B2- Riboflavin 5’ Phosphate Sodium, B6- Pyridoxine Hydrochloride, B5- Dexpanthenol, B3- Niacinamide, Vitamin C, Vitamin B-12, Arginine, L-Glutamine, Biotin, and Zinc.
[0005] Provided herein are compositions, comprising: an aqueous mixture of a B- Complex, where the B-Complex comprises: Bl -Thiamine Hydrochloride, B2- Riboflavin 5’ Phosphate Sodium, B6- Pyridoxine Hydrochloride, B5- Dexpanthenol, B3- Niacinamide, Vitamin C, Vitamin B-12, and zinc. In some embodiments, the composition comprises about 3 mg / ml Vitamin B 1 and / or Vitamin B3. In some embodiments, the composition comprises about 0.06 mg / ml Vitamin B2, Vitamin B6, and / or Vitamin B5. In some embodiments, the composition comprises about 15 mg / ml Vitamin C. In some embodiments, the composition comprises about 20 pg / ml Vitamin B-12. In some embodiments, the composition comprises about 0.1 mg / ml zinc. In some embodiments, the composition further comprises glutathione and / or NAD+. In some embodiments, the composition further comprises arginine. In some embodiments, the arginine is about 1 mg / ml arginine. In some embodiments, the composition further comprises glutamine. In some embodiments, the glutamine comprises 0.25 mg / ml L- glutamine. In some embodiments, the composition comprises biotin. In some embodiments, the composition comprises 0.1 mg / ml biotin.
[0006] Provided herein are methods of decreasing, ameliorating, or mitigating at least one negative effect of anesthesia, wherein the method comprises administering the compositions described herein to a patient in need thereof. Also provided herein are methods of decreasing, ameliorating, or mitigating at least one complication of a surgical procedure, wherein theDocket No.: 62795.2WO01 method comprises administering the compositions described herein to a patient in need thereof. In some embodiments, the at least one complication of anesthesia comprises grogginess, loss of mental clarity, loss of alertness, delayed emergence from anesthesia, and brain fog. In some embodiments, the at least one complication of the surgical procedure comprises nausea, decreased immunity, increased risk of infection, deep vein thrombosis, scarring, and pain. In some embodiments, the decreased immunity is a local infection or a systemic infection. In some embodiments, the composition decreases or reduces administration of a second medicament to the patient. In some embodiments, the patient does not receive a second medicament. In some embodiments, the second medicament comprises an anti-nausea medication, an analgesic, an antiviral, or an antibiotic. In some embodiments, the patient: has an emergence / wake up time score of accelerated, normal, or prolonged / slower; has a mental clarity score of high, medium, or low; has a nausea / vomiting score of frequent, normal, or rare; has a pain level in PACU score of low, medium, or high; has a PACU discharge time score of accelerated, normal, or prolonged; has a postoperative mobility score of early, normal, or delayed; has a postoperative infection score of infection or none; has a wound healing quality score of excellent, normal, or less ideal; has a scar formation / keloid score of minimal, normal, or moderate; or has a patient satisfaction score of very high, high, or mixed. In some embodiments, the patient is a human. In some embodiments, the surgical procedure is an in-patient procedure or an out-patient procedure. In some embodiments, the patient is administered an anesthetic. In some embodiments, the anesthetic is a general anesthetic. In some embodiments, the general anesthetic is propofol. In some embodiments, the anesthetic is administered intravenously. In some embodiments, the anesthetic is administered with an adjunct medication. In some embodiments, the patient has one or more better scores compared to a patient who did not receive IV fluid post-operatively. In some embodiments, the patient has one or more better scores compared to a patient who did not receive IV fluid comprising arginine and glutamine post-operatively.BRIEF DESCRIPTION OF FIGURES
[0007] FIG. 1 summarizes the number of patients for each emergence time / wake up time score. No IV represents patients who did not receive IV fluid, Version 1 represents patients who received Version 1 of the IV fluid, Version 2 represents patients who received Version 2 of the IV fluid, and Version 3 represents patients who received Version 3 of the IV fluid.
[0008] FIG. 2 summarizes the number of patients for each mental clarity score. No IV represents patients who did not receive IV fluid, Version 1 represents patients who receivedDocket No.: 62795.2WO01Version 1 of the IV fluid, Version 2 represents patients who received Version 2 of the IV fluid, and Version 3 represents patients who received Version 3 of the IV fluid.
[0009] FIG. 3 summarizes the number of patients for each nausea / vomiting score. No IV represents patients who did not receive IV fluid, Version 1 represents patients who received Version 1 of the IV fluid, Version 2 represents patients who received Version 2 of the IV fluid, and Version 3 represents patients who received Version 3 of the IV fluid.
[0010] FIG. 4 summarizes the number of patients for each pain level in Post Operative Care Unit (PACU) score. No IV represents patients who did not receive IV fluid, Version 1 represents patients who received Version 1 of the IV fluid, Version 2 represents patients who received Version 2 of the IV fluid, and Version 3 represents patients who received Version 3 of the IV fluid.
[0011] FIG. 5 summarizes the number of patients for each Post Operative Care Unit (PACU) discharge time score. No IV represents patients who did not receive IV fluid, Version 1 represents patients who received Version 1 of the IV fluid, Version 2 represents patients who received Version 2 of the IV fluid, and Version 3 represents patients who received Version 3 of the IV fluid.
[0012] FIG. 6 summarizes the number of patients for each postoperative mobility score. No IV represents patients who did not receive IV fluid, Version 1 represents patients who received Version 1 of the IV fluid, Version 2 represents patients who received Version 2 of the IV fluid, and Version 3 represents patients who received Version 3 of the IV fluid.
[0013] FIG. 7 summarizes the number of patients for each postoperative infection score. No IV represents patients who did not receive IV fluid, Version 1 represents patients who received Version 1 of the IV fluid, Version 2 represents patients who received Version 2 of the IV fluid, and Version 3 represents patients who received Version 3 of the IV fluid.
[0014] FIG. 8 summarizes the number of patients for each wound healing quality score. No IV represents patients who did not receive IV fluid, Version 1 represents patients who received Version 1 of the IV fluid, Version 2 represents patients who received Version 2 of the IV fluid, and Version 3 represents patients who received Version 3 of the IV fluid.
[0015] FIG. 9 summarizes the number of patients for each scar formation / keloid score. No IV represents patients who did not receive IV fluid, Version 1 represents patients who received Version 1 of the IV fluid, Version 2 represents patients who received Version 2 of the IV fluid, and Version 3 represents patients who received Version 3 of the IV fluid.
[0016] FIG. 10 summarizes the number of patients for each patient satisfaction score. No IV represents patients who did not receive IV fluid, Version 1 represents patients who receivedDocket No.: 62795.2WO01Version 1 of the IV fluid, Version 2 represents patients who received Version 2 of the IV fluid, and Version 3 represents patients who received Version 3 of the IV fluid.DETAILED DESCRIPTION
[0017] The following description provides exemplary aspects of the present disclosure. Such description is not intended as a limitation on the scope of the present disclosure. Rather, the description also encompasses combinations and modifications to the exemplary aspects described herein.DEFINITIONS
[0018] Unless defined otherwise, all technical and scientific terms used herein have the same meaning as is commonly understood by one of skill in the art. It is to be understood that the general description and the following detailed description are exemplary and are non- restrictive of the subject matter claimed. In this application, the use of the singular includes the plural unless specifically stated otherwise. It must be noted that, as used in the specification and the appended claims, the singular forms “a,” “an” and “the” include plural referents unless the context clearly dictates otherwise. Use of the term “including” as well as other forms, such as “include”, “includes,” and “included,” is not limiting.
[0019] The section headings used herein are for organizational purposes only and are not to be construed as limiting the subject matter described. All documents, or portions of documents, cited in the application including, but not limited to, patents, patent applications, articles, books, and manuals are hereby expressly incorporated by reference in their entirety for any purpose.
[0020] The term “about” when used before a numerical value indicates that the value may vary within a reasonable range, such as within 10%, within 5%, or within 1% of the stated value.
[0021] As used herein, the term “comprising” or its grammatic variants is intended to mean that the compositions and methods, etc., include the recited elements, but do not exclude others.
[0022] As used herein, the term "composition" may refer to a mixture or combination of two or more components, including active agents and excipients, that are combined to form a unified product for therapeutic, nutritional, or other purposes.
[0023] As used herein, the term "formulation" may refer to the process of combining ingredients in specific proportions and forms to create a composition, or may refer to the resulting composition itself, including the selection and arrangement of components to achieve desired properties.Docket No.: 62795.2WO01
[0024] As used herein, the term "mg" may refer to milligrams.
[0025] As used herein, the term "|ig" or “mcg” may refer to micrograms.
[0026] As used herein, the term "mg / ml" may refer to milligrams per milliliter, a unit of concentration expressing the mass of a substance in milligrams contained within one milliliter of solution or suspension.
[0027] As used herein, the term "ug / ml" may refer to micrograms per milliliter, a unit of concentration expressing the mass of a substance in micrograms contained within one milliliter of solution or suspension.
[0028] As used herein, the term "nutrients" may refer to substances that provide nourishment essential for growth, metabolism, and physiological function, including macronutrients such as carbohydrates, proteins, and fats, as well as micronutrients such as vitamins and minerals.
[0029] As used herein, the term "electrolytes" may refer to substances that dissociate into ions when dissolved in solution and are capable of conducting electrical current. Non-limiting examples include sodium, potassium, chloride, calcium, magnesium, and phosphate ions.
[0030] As used herein, the term "amino acid" may refer to organic compounds containing both amino and carboxyl functional groups that serve as building blocks of proteins and may function in various metabolic processes.
[0031] As used herein, the term "pre" may refer to before, prior to, or preceding a specified event, procedure, or time period.
[0032] As used herein, the term "post" may refer to after, following, or subsequent to a specified event, procedure, or time period.
[0033] As used herein, the term "intravenous" may refer to administration or delivery directly into a vein, allowing substances to enter the bloodstream immediately.
[0034] As used herein, the term "pharmaceutically acceptable excipient" may refer to an inactive substance that is suitable for use in pharmaceutical formulations and is generally recognized as safe for human consumption, serving functions such as stabilization without adversely affecting the therapeutic activity of the active ingredient(s).I. COMPOSITIONS
[0035] Patients experience several challenges physiologically and cognitively as they as they emerge from anesthesia as the body metabolizes the anesthetic agents. Furthermore, the patient must also recover from the surgery itself. The compositions described herein may be useful for both recovery from anesthesia and post-surgical recovery.Docket No.: 62795.2WO01
[0036] Disclosed herein are compositions comprising an aqueous mixture of a B- Complex, Vitamin C, Vitamin B-12, and zinc. Also provided herein are compositions comprising an aqueous mixture of a B-Complex, Vitamin C, Vitamin B-12, and zinc, wherein the B-Complex comprises thiamine hydrochloride, riboflavin 5’ phosphate sodium, pyridoxine hydrochloride, dexpanthenol, and niacinamide. In some embodiments, the composition further comprises glutathione, NAD+, and / or biotin.
[0037] Also provided herein are compositions comprising an aqueous mixture of a B- Complex, Vitamin C, Vitamin B-12, arginine, glutamine, and zinc, wherein the B-Complex comprises thiamine hydrochloride, riboflavin 5’ phosphate sodium, pyridoxine hydrochloride, dexpanthenol, and niacinamide. In some embodiments, the composition further comprises glutathione, NAD+, and / or biotin.
[0038] Also provided herein are compositions comprising an aqueous mixture of a B- Complex, Vitamin C, Vitamin B-12, arginine, glutamine, zinc, and biotin, wherein the B- Complex comprises thiamine hydrochloride, riboflavin 5’ phosphate sodium, pyridoxine hydrochloride, dexpanthenol, and niacinamide. In some embodiments, the composition further comprises glutathione and / or NAD+.
[0039] In some embodiments, the compositions described herein may further comprise additional ingredients. Non-limiting examples include one or more pharmaceutically acceptable excipients, amino acids, or electrolytes.A. B-Complex
[0040] Provided herein are compositions comprising B-Complex. B-Complex describes a group of B vitamins that are essential for health. In some embodiments, B-Complex comprises thiamine (Bl), riboflavin (b2), niacin (B3), pantothenic acid (B5), pyridoxine (B6), biotin (B7), and folate (B9). In some embodiments, B-Complex consists of thiamine (Bl), riboflavin (B2), niacin (B3), pantothenic acid (B5), pyridoxine (B6), biotin (B7), and folate (B9). The compositions described herein may be reconstituted by diluting a volume of B-Complex formula comprising lOOmg / ml Bl, 2mg / ml B2, 2mg / ml B6, 2mg / ml B5, lOOmg / ml B3 into 50 mL of a common IV base carrier such as but not limited to normal saline solution or lactated Ringers solution. The compositions described herein may be also reconstituted by diluting a volume of B-Complex formula, wherein the B-Complex formula comprises lOOmg / ml Bl, 2mg / ml B2, 2mg / ml B6, 2mg / ml B5, lOOmg / ml B3 into 100 mL of a common IV base carrier such as but not limited to normal saline solution or lactated Ringers solution. In some embodiments, the volume of B-Complex formula to be diluted is about 1 mL. In someDocket No.: 62795.2WO01 embodiments, the volume of B-Complex formula to be diluted is about 3 mL. In some embodiments, the volume of B-Complex formula to be diluted is about 4 mL. In some embodiments, the volume of B-Complex formula to be diluted is about 5 mL. In some embodiments, the volume of B-Complex formula to be diluted is about 30 mL. In some embodiments, the volume of B-Complex formula to be diluted is 1 mL. In some embodiments, the volume of B-Complex formula to be diluted is 3 mL. In some embodiments, the volume of B-Complex formula to be diluted is 4 mL. In some embodiments, the volume of B-Complex formula to be diluted is 5 mL. In some embodiments, the volume of B-Complex formula to be diluted is 30 mL.
[0041] In some embodiments, the composition comprises about 1 mg / ml, about 1.5 mg / ml, about 2 mg / ml, about 3 mg / ml, about 4 mg / ml, about 5 mg / ml, about 6 mg / ml, about 8 mg / ml, about 10 mg / ml, about 20 mg / ml, about 30 mg / ml, or about 60 mg / ml thiamine (Bl). In some embodiments, the composition comprises about 1.5 mg / ml thiamine (Bl). In some embodiments, the composition comprises about 3 mg / ml thiamine (Bl). In some embodiments, the composition comprises about 6 mg / ml thiamine (B l). In some embodiments, the composition comprises 1 mg / ml, 1.5 mg / ml, 2 mg / ml, 3 mg / ml, 4 mg / ml, 5 mg / ml, 6 mg / ml, 8 mg / ml, 10 mg / ml, 20 mg / ml, 30 mg / ml, or 60 mg / ml thiamine (Bl). In some embodiments, the composition comprises 1.5 mg / ml thiamine (Bl). In In some embodiments, the composition comprises 3 mg / ml thiamine (Bl). In some embodiments, the composition comprises 6 mg / ml thiamine (Bl).
[0042] In some embodiments, the composition comprises about 0.02 mg / ml, about 0.03 mg / ml, about 0.04 mg / ml, about 0.06 mg / ml, about 0.08 mg / ml, about 0.1 mg / ml, about 0.12 mg / ml, about 0.16 mg / ml, about 0.2 mg / ml, about 0.4 mg / ml, about 0.6 mg / ml, or about 1.2 mg / ml riboflavin (B2). In some embodiments, the composition comprises about 0.03 mg / ml riboflavin (B2). In some embodiments, the composition comprises about 0.06 mg / ml riboflavin (B2). In some embodiments, the composition comprises about 0.12 mg / ml riboflavin (B2). In some embodiments, the composition comprises 0.02 mg / ml, 0.03 mg / ml, 0.04 mg / ml, 0.06 mg / ml, 0.08 mg / ml, 0.1 mg / ml, 0.12 mg / ml, 0.16 mg / ml, 0.2 mg / ml, 0.4 mg / ml, 0.6 mg / ml, or 1.2 mg / ml riboflavin (B2). In some embodiments, the composition comprises 0.03 mg / ml riboflavin (B2). In some embodiments, the composition comprises 0.06 mg / ml riboflavin (B2). In some embodiments, the composition comprises 0.12 mg / ml riboflavin (B2). In some embodiments, the riboflavin is riboflavin 5’ phosphate sodium.
[0043] In some embodiments, the composition comprises about 0.02 mg / ml, about 0.03 mg / ml, about 0.04 mg / ml, about 0.06 mg / ml, about 0.08 mg / ml, about 0.1 mg / ml, about 0.12Docket No.: 62795.2WO01 mg / ml, about 0.16 mg / ml, about 0.2 mg / ml, about 0.4 mg / ml, about 0.6 mg / ml, or about 1.2 mg / ml pyridoxine (B6). In some embodiments, the composition comprises about 0.03 mg / ml pyridoxine (B6). In some embodiments, the composition comprises about 0.06 mg / ml pyridoxine (B6). In some embodiments, the composition comprises about 0.12 mg / ml pyridoxine (B6). In some embodiments, the composition comprises 0.02 mg / ml, 0.03 mg / ml, 0.04 mg / ml, 0.06 mg / ml, 0.08 mg / ml, 0.1 mg / ml, 0.12 mg / ml, 0.16 mg / ml, 0.2 mg / ml, 0.4 mg / ml, 0.6 mg / ml, or 1.2 mg / ml pyridoxine (B6). In some embodiments, the composition comprises 0.03 mg / ml pyridoxine (B6). In some embodiments, the composition comprises 0.06 mg / ml pyridoxine (B6). In some embodiments, the composition comprises 0.12 mg / ml pyridoxine (B6). In some embodiments, the riboflavin is riboflavin 5’ phosphate sodium.
[0044] In some embodiments, the composition comprises about 0.02 mg / ml, about 0.03 mg / ml, about 0.04 mg / ml, about 0.06 mg / ml, about 0.08 mg / ml, about 0.1 mg / ml, about 0.12 mg / ml, about 0.16 mg / ml, about 0.2 mg / ml, about 0.4 mg / ml, about 0.6 mg / ml, or about 1.2 mg / ml dexpanthenol (B5). In some embodiments, the composition comprises about 0.03 mg / ml dexpanthenol (B5). In some embodiments, the composition comprises about 0.06 mg / ml dexpanthenol (B5). In some embodiments, the composition comprises about 0.12 mg / ml dexpanthenol (B5). In some embodiments, the composition comprises 0.02 mg / ml, 0.03 mg / ml, 0.04 mg / ml, 0.06 mg / ml, 0.08 mg / ml, 0.1 mg / ml, 0.12 mg / ml, 0.16 mg / ml, 0.2 mg / ml, 0.4 mg / ml, 0.6 mg / ml, or 1.2 mg / ml dexpanthenol (B5). In some embodiments, the composition comprises 0.03 mg / ml dexpanthenol (B5). In some embodiments, the composition comprises 0.06 mg / ml dexpanthenol (B5). In some embodiments, the composition comprises 0.12 mg / ml dexpanthenol (B5). In some embodiments, the riboflavin is riboflavin 5’ phosphate sodium.
[0045] In some embodiments, the composition comprises about 1 mg / ml, about 1.5 mg / ml, about 2 mg / ml, about 3 mg / ml, about 4 mg / ml, about 5 mg / ml, about 6 mg / ml, about 8 mg / ml, about 10 mg / ml, about 20 mg / ml, about 30 mg / ml, or about 60 mg / ml niacin (B3). In some embodiments, the composition comprises about 1.5 mg / ml niacin (B3). In some embodiments, the composition comprises about 3 mg / ml niacin (B3). In some embodiments, the composition comprises about 6 mg / ml niacin (B3). In some embodiments, the composition comprises 1 mg / ml, 1.5 mg / ml, 2 mg / ml, 3 mg / ml, 4 mg / ml, 5 mg / ml, 6 mg / ml, 8 mg / ml, 10 mg / ml, 20 mg / ml, 30 mg / ml, or 60 mg / ml niacin (B3). In some embodiments, the composition comprises 1.5 mg / ml niacin (B3). In some embodiments, the composition comprises 3 mg / ml niacin (B3). In some embodiments, the composition comprises 6 mg / ml niacin (B3).Docket No.: 62795.2WO01B. Vitamin B- 12
[0046] The compositions provided herein comprise Vitamin B-12 (e.g., B-12). Vitamin B- 12 is also known as cobalamin. In some embodiments, the composition comprises about 5 pg / ml, about 10 g / ml, about 20 g / ml, about 40 pg / ml, about 50 pg / ml, about 80 pg / ml, about 100 pg / ml, about 200 pg / ml, about 300 pg / ml, about 400 pg / ml, about 500 pg / ml, about 600 g / ml, or about 1200 pg / ml cobalamin. In some embodiments, the composition comprises about 20 pg / ml to about 50 pg / ml cobalamin. In some embodiments, the composition comprises about 10 pg / ml cobalamin. In some embodiments, the composition comprises about 20 pg / ml cobalamin. In some embodiments, the composition comprises about 40 pg / ml cobalamin. In some embodiments, the composition comprises 5 pg / ml, 10 pg / ml, 20 pg / ml, 40 pg / ml, 50 pg / ml, 80 pg / ml, 100 pg / ml, 200 pg / ml, 300 pg / ml, 400 pg / ml, 500 pg / ml, 600 pg / ml, or 1200 pg / ml. In some embodiments, the composition comprises 20 pg / ml to 50 pg / ml cobalamin. In some embodiments, the composition comprises 10 pg / ml cobalamin. In some embodiments, the composition comprises 20 pg / ml cobalamin. In some embodiments, the composition comprises 40 pg / ml cobalamin. In some embodiments, the cobalamin is cyanocobalamin or hydroxocobalamin.C. Vitamin C
[0047] The compositions provided herein comprise Vitamin C. Vitamin C is also known as ascorbic acid. In some embodiments, the composition comprises about 5 mg / ml, about 10 mg / ml, about 15 mg / ml, about 20 mg / ml, about 30 mg / ml, about 40 mg / ml, about 50 mg / ml, about 80 mg / ml, about 100 mg / ml, about 200 mg / ml, or about 300 mg / ml ascorbic acid. In some embodiments, the composition comprises about 10 mg / ml to about 30 mg / ml ascorbic acid. In some embodiments, the composition comprises about 10 mg / ml ascorbic acid. In some embodiments, the composition comprises about 15 mg / ml ascorbic acid. In some embodiments, the composition comprises about 30 mg / ml ascorbic acid. In some embodiments, the composition comprises 5 mg / ml, 10 mg / ml, 15 mg / ml, 20 mg / ml, 30 mg / ml, 40 mg / ml, 50 mg / ml, 80 mg / ml, 100 mg / ml, 200 mg / ml, or 300 mg / ml ascorbic acid. In some embodiments, the composition comprises 10 mg / ml to 30 mg / ml ascorbic acid. In some embodiments, the composition comprises 10 mg / ml ascorbic acid. In some embodiments, the composition comprises 15 mg / ml ascorbic acid. In some embodiments, the composition comprises 30 mg / ml ascorbic acid.Docket No.: 62795.2WO01D. Zinc
[0048] The compositions provided herein comprise zinc. In some embodiments, the composition comprises about 0.01 mg / ml, about 0.05 mg / ml, about 0.1 mg / ml, about 0.2 mg / ml, about 0.3 mg / ml, about 0.4 mg / ml, about 0.5 mg / ml, about 0.8 mg / ml, or about 1 mg / ml zinc. In some embodiments, the composition comprises about 0. 1 mg / ml to about 0.2 mg / ml zinc. In some embodiments, the composition comprises about 0.05 mg / ml zinc. In some embodiments, the composition comprises about 0.1 mg / ml zinc. In some embodiments, the composition comprises about 0.2 mg / ml zinc. In some embodiments, the composition comprises 0.01 mg / ml, 0.05 mg / ml, 0.1 mg / ml, 0.2 mg / ml, 0.3 mg / ml, 0.4 mg / ml, 0.5 mg / ml, 0.8 mg / ml, or 1 mg / ml zinc. In some embodiments, the composition comprises 0.1 mg / ml zinc to 0.2 mg / ml zinc. In some embodiments, the composition comprises 0.05 mg / ml zinc. In some embodiments, the composition comprises 0.1 mg / ml zinc. In some embodiments, the composition comprises 0.2 mg / ml zinc.E. Biotin
[0049] The compositions provided herein may further comprise biotin. In some embodiments, the composition comprises about 0.01 mg / ml, about 0.05 mg / ml, about 0.1 mg / ml, about 0.2 mg / ml, about 0.3 mg / ml, about 0.4 mg / ml, about 0.5 mg / ml, about 1 mg / ml, or about 2 mg / ml biotin. In some embodiments, the composition comprises about 0.1 mg / ml to about 0.2 mg / ml biotin. In some embodiments, the composition comprises about 0.1 mg / ml biotin. In some embodiments, the composition comprises about 0.2 mg / ml biotin. In some embodiments, the composition comprises 0.01 mg / ml, 0.05 mg / ml, 0.1 mg / ml, 0.2 mg / ml, 0.3 mg / ml, 0.4 mg / ml, 0.5 mg / ml, 1 mg / ml, or 2 mg / ml biotin. In some embodiments, the composition comprises 0.1 mg / ml biotin to 0.2 mg / ml biotin. In some embodiments, the composition comprises 0.1 mg / ml biotin. In some embodiments, the composition comprises 0.2 mg / ml biotin.F. Arginine
[0050] The compositions provided herein may further comprise arginine. Arginine is an amino acid. In some embodiments, the composition comprises about 0.05 mg / ml, about 0.1 mg / ml, about 0.2 mg / ml, about 0.3 mg / ml, about 0.4 mg / ml, about 0.5 mg / ml, about 1 mg / ml, about 2 mg / ml, about 3 mg / ml, about 4 mg / ml, about 5 mg / ml, or about 10 mg / ml arginine. In some embodiments, the composition comprises about 1 mg / ml to about 2 mg / ml arginine. In some embodiments, the composition comprises about 1 mg / ml arginine. In some embodiments,Docket No.: 62795.2WO01 the composition comprises about 2 mg / ml arginine. In some embodiments, the composition comprises 0.05 mg / ml, 0.1 mg / ml, 0.2 mg / ml, 0.3 mg / ml, 0.4 mg / ml, 0.5 mg / ml, 1 mg / ml, 2 mg / ml, 3 mg / ml, 4 mg / ml, 5 mg / ml, or 10 mg / ml arginine. In some embodiments, the composition comprises 1 mg / ml arginine to 2 mg / ml arginine. In some embodiments, the composition comprises 1 mg / ml arginine. In some embodiments, the composition comprises 2 mg / ml arginine. In some embodiments, the arginine is L-arginine.G. Glutamine[00511 The compositions provided herein may further comprise glutamine. Glutamine is an amino acid. In some embodiments, the composition comprises about 0. 1 mg / ml, about 0.2 mg / ml, about 0.25 mg / ml, about 0.3 mg / ml, about 0.4 mg / ml, about 0.5 mg / ml, about 1 mg / ml, about 2 mg / ml, about 5 mg / ml, about 10 mg / ml, about 50 mg / ml, about 100 mg / ml or about 200 mg / ml glutamine. In some embodiments, the composition comprises about 0.25 mg / ml to about 1 mg / ml glutamine. In some embodiments, the composition comprises about 0.25 mg / ml glutamine. In some embodiments, the composition comprises about 0.5 mg / ml glutamine. In some embodiments, the composition comprises about 1 mg / ml glutamine. In some embodiments, the composition comprises 0.1 mg / ml, 0.2 mg / ml, 0.25 mg / ml, 0.3 mg / ml, 0.4 mg / ml, 0.5 mg / ml, 1 mg / ml, 2 mg / ml, 5 mg / ml, 10 mg / ml, 50 mg / ml, 100 mg / ml or 200 mg / ml glutamine. In some embodiments, the composition comprises 0.25 mg / ml to 1 mg / ml glutamine. In some embodiments, the composition comprises 0.25 mg / ml glutamine. In some embodiments, the composition comprises 0.5 mg / ml glutamine. In some embodiments, the composition comprises 1 mg / ml glutamine. In some embodiments, the glutamine is L- glutamine.H. Nicotinamide adenine dinucleotide (NAD+)
[0052] The compositions provided herein may further comprise nicotinamide adenine dinucleotide (NAD+). NAD+ is an essential co-enzyme. In some embodiments, the composition comprises about 0.1 mg / ml, about 0.2 mg / ml, about 0.25 mg / ml, about 0.3 mg / ml, about 0.4 mg / ml, about 0.5 mg / ml, about 1 mg / ml, about 2 mg / ml, about 5 mg / ml, about 10 mg / ml, about 20 mg / ml, or about 30 mg / ml NAD+. In some embodiments, the composition comprises about 0.25 mg / ml to about 1 mg / ml NAD+. In some embodiments, the composition comprises about 0.25 mg / ml NAD+. In some embodiments, the composition comprises about 0.5 mg / ml NAD+. In some embodiments, the composition comprises 0.1 mg / ml, 0.2 mg / ml, 0.25 mg / ml, 0.3 mg / ml, 0.4 mg / ml, 0.5 mg / ml, 1 mg / ml, 2 mg / ml, 5 mg / ml, 10 mg / ml, 20Docket No.: 62795.2WO01 mg / ml, or 30 mg / ml NAD+. In some embodiments, the composition comprises 0.25 mg / ml to 1 mg / ml NAD+. In some embodiments, the composition comprises 0.25 mg / ml NAD+. In some embodiments, the composition comprises 0.5 mg / ml NAD+.
[0053] In some embodiments, the composition comprises about 25 mg, about 50 mg, about 100 mg, about 150 mg, about 200 mg, about 500 mg, about 1000 mg, about 1500 mg, about 2000 mg, or about 3000 mg of NAD+ in 100 mL IV fluid. In some embodiments, the composition comprises about 50 mg NAD+ in 100 mL IV fluid. In some embodiments, the composition comprises about 100 mg NAD+ in 100 mL IV fluid. In some embodiments, the composition comprises 25 mg, 50 mg, 100 mg, 150 mg, 200 mg, 500 mg, 1000 mg, 1500 mg, 2000 mg, or 3000 mg of NAD+ in 100 mL IV fluid. In some embodiments, the composition comprises 50 mg NAD+ in 100 mL IV fluid. In some embodiments, the composition comprises 100 mg NAD+ in 100 mL IV fluid.I. Glutathione
[0054] The compositions provided herein may further comprise glutathione. Glutathione is tripeptide that is made of glutamate, cysteine, and glycine. In some embodiments, the composition comprises about 1 mg / ml, about 2 mg / ml, about 5 mg / ml, about 8 mg / ml, about 10 mg / ml, about 50 mg / ml, or about 100 mg / ml glutathione. In some embodiments, the composition comprises about 2 mg / ml to about 8 mg / ml glutathione. In some embodiments, the composition comprises about 2 mg / ml glutathione. In some embodiments, the composition comprises about 4 mg / ml glutathione. In some embodiments, the composition comprises 1 mg / ml, 2 mg / ml, 5 mg / ml, 8 mg / ml, 10 mg / ml, 50 mg / ml, or 100 mg / ml glutathione. In some embodiments, the composition comprises 2 mg / ml to 4 mg / ml glutathione. In some embodiments, the composition comprises 2 mg / ml glutathione. In some embodiments, the composition comprises 4 mg / ml glutathione.
[0055] In some embodiments, the composition comprises about 100 mg, about 200 mg, about 250 mg, about 300 mg, about 350 mg, about 400 mg, about 500 mg, about 1000 mg, about 2500 mg, about 5000 mg, or about 10000 mg of glutathione in 100 mL IV fluid. In some embodiments, the composition comprises about 200 mg glutathione in 100 mL IV fluid. In some embodiments, the composition comprises about 400 mg glutathione in 100 mL IV fluid. In some embodiments, the composition comprises 100 mg, 200 mg, 250 mg, 300 mg, 350 mg, 400 mg, 500 mg, 1000 mg, 2500 mg, 5000 mg, or 10000 mg of glutathione 100 mL IV fluid. In some embodiments, the composition comprises 200 mg glutathione in 100 mL IV fluid. In some embodiments, the composition comprises 400 mg glutathione in 100 mL IV fluid.Docket No.: 62795.2WO01IL EXEMPLARY COMPOSITIONS
[0056] Also provided herein are exemplary compositions and formulations.
[0057] One exemplary composition comprises about 3 mg / ml Bl, about 0.06 mg / ml B2, about 0.06 mg / ml B6, about 0.06 mg / ml B5, about 3 mg / ml B3, about 20 mg / ml ascorbic acid, about 20 pg / ml cobalamin, and about 0.1 mg / ml zinc. In some embodiments, the composition comprises 3 mg / ml Bl, 0.06 mg / ml B2, 0.06 mg / ml B6, 0.06 mg / ml B5, 3 mg / ml B3, 20 mg / ml ascorbic acid, 20 pg / ml cobalamin, and 0.1 mg / ml zinc. In some embodiments, cobalamin is cyanocobalamin or hydroxocobalamin.
[0058] One exemplary composition comprises about 1.5 mg / ml B 1 , about 0.03 mg / ml B2, about 0.03 mg / ml B6, about 0.03 mg / ml B5, about 1.5 mg / ml B3, about 10 mg / ml ascorbic acid, about 10 pg / ml cobalamin, and about 0.05 mg / ml zinc. In some embodiments, the composition comprises 1.5 mg / ml Bl, 0.03 mg / ml B2, 0.03 mg / ml B6, 0.03 mg / ml B5, 1.5 mg / ml B3, 10 mg / ml ascorbic acid, 10 pg / ml cobalamin, and 0.05 mg / ml zinc. In some embodiments, cobalamin is cyanocobalamin or hydroxocobalamin.
[0059] One exemplary composition comprises about 6 mg / ml Bl, about 0.12 mg / ml B2, about 0.12 mg / ml B6, about 0.12 mg / ml B5, about 6 mg / ml B3, about 30 mg / ml ascorbic acid, about 40 pg / ml cobalamin, about 2 mg / ml arginine, about 0.5 mg / ml L-glutamine, and about 0.2 mg / ml zinc. In some embodiments, the composition comprises 6 mg / ml Bl, 0.12 mg / ml B2, 0.12 mg / ml B6, 0.12 mg / ml B5, 6 mg / ml B3, 30 mg / ml ascorbic acid, 40 pg / ml cobalamin, 2 mg / ml arginine, 0.5 mg / ml L-glutamine, and 0.2 mg / ml zinc. In some embodiments, cobalamin is cyanocobalamin or hydroxocobalamin.
[0060] One exemplary composition comprises about 3 mg / ml B l, about 0.06 mg / ml B2, about 0.06 mg / ml B6, about 0.06 mg / ml B5, about 3 mg / ml B3, about 15 mg / ml ascorbic acid, about 20 pg / ml cobalamin, about 1 mg / ml arginine, about 0.25 mg / ml L-glutamine, and about 0.1 mg / ml zinc. In some embodiments, the composition comprises 3 mg / ml Bl, 0.06 mg / ml B2, 0.06 mg / ml B6, 0.06 mg / ml B5, 3 mg / ml B3, 15 mg / ml ascorbic acid, 20 pg / ml cobalamin, 1 mg / ml arginine, 0.25 mg / ml L-glutamine, and 0.1 mg / ml zinc. In some embodiments, cobalamin is cyanocobalamin or hydroxocobalamin.
[0061] One exemplary composition comprises about 6 mg / ml Bl, about 0.12 mg / ml B2, about 0.12 mg / ml B6, about 0.12 mg / ml B5, about 6 mg / ml B3, about 30 mg / ml ascorbic acid, about 40 pg / ml cobalamin, about 2 mg / ml arginine, about 0.5 mg / ml L-glutamine, about 0.2 mg / ml biotin, and about 0.2 mg / ml zinc. In some embodiments, the composition comprises 6 mg / ml Bl, 0.12 mg / ml B2, 0.12 mg / ml B6, 0.12 mg / ml B5, 6 mg / ml B3, 30 mg / ml ascorbicDocket No.: 62795.2WO01 acid, 40 pg / ml cobalamin, 2 mg / ml arginine, 0.5 mg / ml L-glutamine, 0.2 mg / ml biotin, and 0.2 mg / ml zinc. In some embodiments, cobalamin is cyanocobalamin or hydroxocobalamin.
[0062] One exemplary composition comprises about 3 mg / ml B l, about 0.06 mg / ml B2, about 0.06 mg / ml B6, about 0.06 mg / ml B5, about 3 mg / ml B3, about 15 mg / ml ascorbic acid, about 20 pg / ml cobalamin, about 1 mg / ml arginine, about 0.25 mg / ml L-glutamine, about 0.1 mg / ml biotin, and about 0.1 mg / ml zinc. In some embodiments, the composition comprises 3 mg / ml Bl, 0.06 mg / ml B2, 0.06 mg / ml B6, 0.06 mg / ml B5, 3 mg / ml B3, 15 mg / ml ascorbic acid, 20 pg / ml cobalamin, 1 mg / ml arginine, 0.25 mg / ml L-glutamine, 0.1 mg / ml biotin, and 0.1 mg / ml zinc. In some embodiments, cobalamin is cyanocobalamin or hydroxocobalamin.III. METHODS OF USE
[0063] Provided herein are methods of using any of the compositions as described herein. Also provided herein are methods of using any of the exemplary compositions as described herein.
[0064] Also provided herein are methods of decreasing, ameliorating, or mitigating at least one negative effect of anesthesia by administering any of the compositions described herein. Provided herein are methods of decreasing, ameliorating, or mitigating at least one negative effect of anesthesia by administering any of the exemplary compositions described herein. Also provided herein are methods of treating at least one negative effect of anesthesia by administering any of the compositions described herein. Provided herein are methods of treating at least one negative effect of anesthesia by administering any of the exemplary compositions described herein. In some embodiments, the negative effect of anesthesia comprises grogginess, loss of mental clarity, loss of alertness, delayed emergence from anesthesia, and brain fog.
[0065] Also provided herein are methods of decreasing, ameliorating, or mitigating at least one complication of a surgical procedure, wherein the method comprises administering any of the compositions described herein. Provided herein are methods of decreasing, ameliorating, or mitigating at least one complication of a surgical procedure by administering any of the exemplary compositions described herein. Also provided herein are methods of treating at least one complication of a surgical procedure, wherein the method comprises administering any of the compositions described herein. Provided herein are methods of treating at least one complication of a surgical procedure by administering any of the exemplary compositions described herein. In some embodiments, the complication of the surgical procedure comprises nausea, decreased immunity, increased risk of infection, deep veinDocket No.: 62795.2WO01 thrombosis, scarring, and pain. In some embodiments, the decreased immunity is a local infection or a systemic infection. In some embodiments, the patient does not receive a second medicament. In some embodiments, the second medicament comprises an anti-nausea medication, an analgesic, an antiviral, or an antibiotic.
[0066] Also provided herein are methods for mitigating post-surgical inflammation, scarring, and risk of infection comprising intravenously administering any of the compositions described herein. Also provided herein are methods for mitigating post-surgical inflammation, scarring, and risk of infection comprising intravenously administering any of the exemplary compositions described herein.
[0067] Also provided herein are methods of treating post-surgical inflammation, scarring, and risk of infection comprising intravenously administering any of the compositions described herein. Also provided herein are methods for treating post-surgical inflammation, scarring, and risk of infection comprising intravenously administering any of the exemplary compositions described herein.
[0068] Outcomes may be assessed by any of the exemplary standards, or combinations thereof, as set forth in Table 1. In some embodiments, a patient may be assessed, scored or categorized according to any of the following exemplary standards to evaluate benefit. In some embodiments, the patient is assessed, scored, or categorized higher in an exemplary standard if administered any of the compositions described herein compared to a patient who is not administered the same composition. In some embodiments, the composition comprises arginine and glutamine. In some embodiments, the patient who is not administered the same composition receives no composition (e.g., IV fluid) post-operatively. In some embodiments, the patient who is not administered the same composition receives a composition without arginine and glutamine.TABLE 1: EXEMPLARY STANDARDS TO ASSESS PATIENT OUTCOMEDocket No.: 62795.2WO01A. Emergence / Wake Up Time
[0069] In some embodiments, the patient has an emergence / wake up time score of “accelerated.” Non-limiting examples of an accelerated emergence / wake up time score includes awakening within minutes of anesthetic discontinuation, responding appropriately to commands almost immediately, and demonstrating stable vital signs without prolonged grogginess. In some embodiments, the patient has an emergence / wake up time score of “normal.” Non-limiting examples of normal emergence / wake up time includes awakening within the expected average timeframe for the anesthetic used, with brief but normal grogginess before becoming fully interactive. In some embodiments, the patient has an emergence / wake up time score of “prolonged” or “slower.” Non-limiting examples of a prolonged emergence / wake up time includes the observation that the patient requires a significantly longer period than average to achieve eye opening or verbal responsiveness, with extended grogginess or need for repeated stimulation.B. Mental Clarity
[0070] In some embodiments, the patient has a mental clarity score of “high.” Nonlimiting examples of high mental clarity include the ability to respond promptly and accurately to orientation questions, to engage in coherent conversation, to follow complex commands without delay, and shows no signs of confusion. In some embodiments, the patient has a mental clarity score of “medium.” Non-limiting examples of “medium” (e.g., “med”) mental clarityDocket No.: 62795.2WO01 includes responding to questions and commands with minor delays or occasional repetition, patient orientation mostly intact but with brief confusion or slowed processing. In some embodiments, the patient has a mental clarity score of “low.” Non-limiting examples of low mental clarity includes delayed or inconsistent responses, frequent repetition needed, confusion present, and incomplete orientation persisting beyond typical recovery.C. Nausea / Vomiting
[0071] In some embodiments, the patient has a nausea / vomiting score of “rare.” Nonlimiting examples of rare nausea / vomiting includes no nausea or vomiting, or brief, mild symptoms resolving without medication. In some embodiments, the patient has a nausea / vomiting score of “normal.” Non-limiting examples of normal nausea / vomiting includes mild to moderate nausea controlled with standard antiemetics, with occasional vomiting. In some embodiments, the patient has a nausea / vomiting score of “frequent.” Nonlimiting examples of more frequent nausea / vomiting includes persistent or severe nausea requiring multiple antiemetics, repeated vomiting, or delayed oral intake.D. Pain Level in PACU
[0072] In some embodiments, the patient has a pain level in PACU score of “low.” Nonlimiting examples of a patient with a “low” score includes reports of mild pain (0 to 3 out of a total scale of 10) that is well controlled with minimal analgesia. In some embodiments, the patient has a pain level in PACU score of “medium.” Non-limiting examples of a patient with a “medium” (e.g., “med”) score includes reports of moderate pain (4 to 6 out of a total score of 10) requiring standard postoperative analgesics, but manageable. In some embodiments, the patient has a pain level in the PACU score of “high.” Non-limiting examples of a patient with a “high” score includes reports of severe pain (7 to 10 out of a total scale of 10) requiring aggressive analgesia or multiple interventions.E. PACU Discharge Time
[0073] In some embodiments, the patient has a PACU discharge time score of “accelerated.” Non-limiting examples of a patient with an “accelerated” score includes meeting all discharge criteria earlier than average, typically due to stable vitals, rapid orientation, and good pain control. In some embodiments, the patient has a PACU discharge time score of “normal.” Non-limiting examples of a patient with a “normal” score includes meeting discharge criteria within expected average timeframe for procedure and anesthesia type. InDocket No.: 62795.2WO01 some embodiments, the patient has a PACU discharge time score of “prolonged.” Non-limiting examples of a patient with a “prolonged” score includes requiring significantly more time than average due to delayed orientation, pain control challenges, or hemodynamic instability.F. Post-Op Mobility
[0074] In some embodiments, the patient has a post-operational (post-op) mobility score of “early.” Non-limiting examples of a patient with a “early” score includes being able to ambulate or sit upright within hours of surgery with minimal assistance. In some embodiments, the patient has a post-operational (post-op) mobility score of “normal.” Non-limiting examples of a patient with a “normal” score includes being able to ambulate or mobilize within the expected postoperative period with some assistance. In some embodiments, the patient has a post-operational (post-op) mobility score of “delayed.” Non-limiting examples of a patient with a “delayed” score includes requiring extended time or significant assistance to mobilize due to pain, dizziness, or weakness.G. Post-Op Infection
[0075] In some embodiments, the patient has a post-operational (post-op) infection score of “none.” Non-limiting examples of a patient with a “none” score includes no clinical signs of infection (no redness, swelling, warmth, or drainage). In some embodiments, the patient has a post-operational (post-op) infection score of “infection.” Non-limiting examples of a patient with an “infection” score includes presence of local or systemic signs of infection confirmed by clinical assessment or culture.H. Wound Healing Quality
[0076] In some embodiments, the patient has a wound healing quality score of “excellent.” Non-limiting examples of a patient with an “excellent” score includes the observation that wound edges well-approximated, minimal swelling, no drainage, rapid epithelialization. In some embodiments, the patient has a wound healing quality score of “normal.” Non-limiting examples of a patient with a “normal” score includes the observation that wound healing within expected timeframe, and mild swelling or redness resolves without complication. In some embodiments, the patient has a wound healing quality score of “less ideal.” Non-limiting examples of a patient with a “less ideal” score includes the observation that wound healing is slower than expected healing, and there is persistent swelling, redness, or drainage without infection.Docket No.: 62795.2WO01I. Scar Formation / Keloid
[0077] In some embodiments, the patient has a scar formation / keloid score of “minimal.” Non-limiting examples of a patient with a “minimal” score includes the observation of fine, flat, and pale scar(s) with minimal visible tissue elevation.no clinical signs of infection (no redness, swelling, warmth, or drainage). In some embodiments, the patient has a scar formation / keloid score of “normal.” Non-limiting examples of a patient with a “normal” score includes the observation of scar(s) within expected cosmetic outcome, mild thickening possible. In some embodiments, the patient has a scar formation / keloid score of “moderate.” Non-limiting examples of a patient with a “normal” score includes the observation of scar(s) with noticeable thickening, raised or discolored scar(s), and evidence of early keloid or hypertrophic formation.J. Patient Satisfaction
[0078] In some embodiments, the patient has a patient satisfaction score of “very high.” Non-limiting examples of a patient with a “very high” score includes the patient expressing strong satisfaction with rapid recovery, minimal discomfort, and excellent results. In some embodiments, the patient has patient satisfaction score of “high.” Non-limiting examples of a patient with a “high” score includes the patient expressing generally satisfaction but may note minor recovery challenges. In some embodiments, the patient has a patient satisfaction score of “mixed.” Non-limiting examples of a patient with a “mixed” score includes the patient expressing both positive and negative feedback, often due to discomfort or prolonged recovery despite satisfactory results.IV. ADMINISTRATION
[0079] In some embodiments, any of the compositions described herein is administered pre-operatively (e.g., before surgery, prior to surgery, or pre-surgery). In some embodiments, the composition is administered preoperatively up to 4 weeks, up to 3 weeks, up to 2 weeks, or up to 1 week prior to surgery. In some embodiments, the composition is administered pre- operatively up to 6 days, up to 5 days, up to 4 days, up to 3 days, up to 2 days, or up to 1 day prior to surgery. In some embodiments, the composition is administered pre-operatively up to 50 hours, up to 48 hours, up to 40 hours, up to 36 hours, up to 30 hours, up to 24 hours, up to 20 hours, up to 15 hours, up to 10 hours, up to 6 hours, up to 5 hours, up to 4 hours, up to 3 hours, up to 2 hours, or up to 1 hour prior to surgery. In some embodiments, the composition is administered 48 hours prior to surgery. In some embodiments, the composition isDocket No.: 62795.2WO01 administered pre-operatively up to 45 minutes, up to 60 minutes, or up to 90 minutes prior to surgery.
[0080] In some embodiments, any of the compositions described herein is administered post-operatively (e.g., after surgery or post-surgery). In some embodiments, the composition is administered between about 5 minutes and about 90 minutes post-surgery. In some embodiments, the composition is administered between about 15 minutes and about 90 minutes post-surgery. In some embodiments, the composition is administered between about 15 minutes and about 45 minutes post-surgery. In some embodiments, the composition is administered between about 10 minutes and about 30 minutes post-surgery. In some embodiments, the composition is administered within about one hour, within about two hours, or within about 3 hours post-surgery. In some embodiments, the composition is administered within about 15 minutes, within about 30 minutes, within about 45 minutes, within about 60 minutes, or within about 90 minutes post- surgery. In some embodiments, the composition is administered within one hour, within two hours, or within 3 hours post-surgery. In some embodiments, the composition is administered within 15 minutes, within 30 minutes, within 45 minutes, within 60 minutes, or within 90 minutes post-surgery. In some embodiments, the composition is administered up to 1 week, up to 2 weeks, up to 3 weeks, up to 4 weeks, up to 5 weeks, up to 6 weeks, up to 7 weeks, or up to 8 weeks post-surgery.
[0081] In some embodiments, the composition is administered both pre-operatively and post-operatively.
[0082] In some embodiments, the composition is administered to a patient in need thereof one or more times. In some embodiments, the composition is administered to a patient in need thereof once. In some embodiments, the composition is administered to a patient in need thereof twice. In some embodiments, the composition is administered to a patient in need thereof three times. In some embodiments, the composition is administered to a patient in need thereof four times.
[0083] In some embodiments, the patient is human. In some embodiments, the patient has had a surgery. In some embodiments, the patient will have a surgery. In some embodiments, the surgery is an outpatient surgery.
[0084] In some embodiments, the patient is administered an anesthetic. In some embodiments, the anesthetic is administered by inhalation. In some embodiments, the anesthetic is administered intravenously (e.g., an intravenous anesthetic). In some embodiments, the intravenous anesthetic is propofol. In some embodiments, the anesthetic is a local anesthetic. In some embodiments, the local anesthetic is lidocaine. In some embodiments,Docket No.: 62795.2WO01 the anesthetic is administered with an adjunct medication. In some embodiments, the adjunct medication is fentanyl, midazolam, succinylcholine, rocuronium, Ondansetron, or dexamethasone.V. KITS
[0085] Also provided herein are kits that comprise any of the compositions described herein. In some embodiments, the kit comprises a carrier bag comprising a composition, such as any of the compositions described herein. In some embodiments, the kit comprises a carrier bag comprising a composition, such as any of the exemplary compositions described herein. In some embodiments, the kit comprises a carrier bag comprising the composition and instructional materials (e.g., instructions) for proper administration and use.
[0086] In some embodiments, the kit comprises one or more vials, comprising stock solutions (e.g., concentrated solutions) that will be diluted in common IV fluid to achieve any of the compositions described herein, such as any of the exemplary compositions described herein.VI. EXAMPLES
[0087] According to the present invention, the composition, its associated benefits and method of administration is disclosed below:Composition prior to reconstitution into carrier bag:B-Complex (Bl lOOmg / ml, B2 2mg / ml, B6 2mg / ml, B5 2mg / ml, B3 lOOmg / ml): high 30ml, low 1ml, optimal 3-5mIBl -Thiamine Hydrochloride lOOmg / mlB2- Riboflavin 5’ Phosphate Sodium 2mg / mlB6- Pyridoxine Hydrochloride 2mg / mlB5- Dexpanthenol 2mg / mlB3- Niacinamide lOOmg / mlVitamin C (ascorbic acid 500mg / ml)): high 30,000mg, low 50mg, optimal 15OO-3OOOmgVitamin B-12 (cyanocobalamin or hydroxocobalamin 2000mcg / ml): high 60000mcg, low 500mcg, optimal 2000-5000mcgArginine (lOOmg / ml): high lOgrams, low 50mg, optimal I00-200mg L-Glutamine (25mg / ml): high 20grams, low lOmg, optimal 25-50mg Biotin lOmg / ml): high 200mg, low Img, optimal 10-20mgZinc: high lOOmg, low Img, optimal 10-20mgDocket No.: 62795.2WO01
[0088] In addition, the present invention contemplates optional ingredients that can be added, including Glutathione push (low lOOmg, high 10,000mg, optimal 200-400mg). This is a powerful antioxidant that flushes and gets rid of free radicals which are toxins that cause oxidative stress on cells that are formed either from the stress of surgery on the body or from certain anesthetics.
[0089] Another optional ingredient is NAD+ which can increase energy levels, decrease brain fog, and promote healing (low 25mg, high 3000mg, optimal 50-200mg).
[0090] As will be understood in the art, any other additional nutrient can be added to the drip depending on the patients wants and needs.
[0091] Beneficial Effects: Promotes smooth recovery from anesthesia and decreases grogginess; decreases the incidence of nausea and vomiting; decreases brain fog while increasing mental alertness, clarity, energy, and focus; decreases PACU recovery room time as patients are more awake and sooner and can therefore be discharged sooner, less need for admission to hospitals or overnight facilities for patient monitoring due to rapid recovery; promotes collagen synthesis and wound healing leading to better cosmetic results with less scarring and keloid formation; significantly improves patient satisfaction scores with surgical experience and outcomes; decreases post-operative pain and the need for opioid usage following surgery; boosts immunity to decrease the incidence of local and / or systemic infection; the extra energy helps patients get back to being active faster and therefore potentially decreasing the incidence of DVT (deep vein thrombosis) in surgical patients.
[0092] Route of administration: Intra- venous route with the composition of medications being reconstituted into Normal Saline solution, Lactated Ringers solution, or any other suitable IV base carrier. Optimal volume for carrier bag is lOOcc. Duration of administration range is between IV push (between 5 seconds to 5 hours. Optimal duration of administration is between 10-20 minutes.
[0093] Composition of ingredient concentrations at optimal doses when reconstituted in 100ml carrier:B-Complex optimal dose = 3ml which gives the following B dosesBl = 300mg in 100ml carrier = 3mg / mlB2 = 6mg in 100ml carrier = 0.06mg / mlB6 = 6mg in 100ml carrier = 0.06mg / mlB5 = 6mg in 100ml carrier - 0.06mg / mlB3 = 300mg in 100ml carrier = 3mg / mlVitamin C (ascorbic acid) 3ml: 1500mg in 100ml carrier = 15mg / mlDocket No.: 62795.2WO01Vitamin B-12 (cyanocobalamin or hydroxocobalamin): 2000mcg in 100ml carrier = 20mcg / ml Arginine: lOOmg in 100ml carrier = Img / mlL-Glutamine: 25mg in 100ml carrier = 0.25mg / mlBiotin: lOmg in 100ml carrier = O.lmg / mlZinc: lOmg in 100ml carrier = O.lmg / ml
[0094] When can you give the drip? Up to 4 weeks before surgery date and up to 8 weeks after surgery date. The drip ((e.g., the composition) may be repeated once a week during that time frame as well. The most optimal time to receive the drip is within 48 hours of surgery and once a week after that for a total of 4 drips. Patients may continue the drip once a week after that for if needed or desired.
[0095] How is the new formulation different than previous formulation? The previous formulation was not composed of all the same ingredients and dosages of ingredients that the new formulation does and therefore was not as effective. Biotin, L- Arginine, and L-Glutamine were not in the old formulation but have since been added to the new formulation. Also, dosages of B-Complex, Vitamin C, B-12, and Zinc have all had an increase / adjustment in dosage to make the product more effective. The previous formulation IV bag was still yellow in color due to the B-Complex but the color of the new formulation is yellow-orange which has to do the adjustment in the composition and dosages of ingredients.
[0096] The patients below underwent various surgeries and were administered general anesthesia. The patient received fluid intravenously (e.g., IV fluid) or no IV fluid post- operatively. The patients who were administered IV fluid received one of the three formulations listed in Table 2. The IV fluid was prepared by dissolving stock solutions of each ingredients in saline or lactated Ringers solution.TABLE 2: FORMULATION RECIPESDocket No.: 62795.2WO01
[0097] Version 3 differed from Version 2 because it comprised biotin. The patients were monitored post-operatively in a PACU until they could be safely discharged per hospital protocol. Patients were surveyed post-operatively at surgery follow-up appointments. The following tables (Tables 3-10) summarize the outcomes of immediate post-operative recovery from anesthesia, as well as their surgical outcomes. These results were further analyzed.TABLE 3: SUMMARY OF POST OPERATIVE RECOVERY SCORES OF PATIENTS WHO RECEIVED VERSION 1 OF THE IV FLUID POST- OPERATIVELY.Docket No.: 62795.2WO01TABLE 4: SUMMARY OF SURGICAL RECOVERY SCORES OF PATIENTS WHO RECEIVED VERSION 1 OF THE IV FLUID POST-OPERATIVELY.Docket No.: 62795.2WO01TABLE 5: SUMMARY OF POST OPERATIVE RECOVERY SCORES OF PATIENTS WHO RECEIVED VERSION 2 OF THE IV FLUID POST- OPERATIVELY.TABLE 6: SUMMARY OF SURGICAL RECOVERY SCORES OF PATIENTS WHO RECEIVED VERSION 2 OF THE IV FLUID POST-OPERATIVELY.Docket No.: 62795.2WO01TABLE 7: SUMMARY OF POST OPERATIVE RECOVERY SCORES OF PATIENTS WHO RECEIVED VERSION 3 OF THE IV FLUID POST- OPERATIVELY.Docket No.: 62795.2WO01TABLE 8: SUMMARY OF SURGICAL RECOVERY SCORES OF PATIENTS WHO RECEIVED VERSION 3 OF THE IV FLUID POST-OPERATIVELY.TABLE 9: SUMMARY OF POST OPERATIVE RECOVERY SCORES OF PATIENTS WHO DID NOT RECEIVE IV FLUID POST-OPERATIVELY.Docket No.: 62795.2WO01TABLE 10: SUMMARY OF SURGICAL RECOVERY SCORES OF PATIENTS WHO RECEIVED NO IV FLUID POST-OPERATIVELY.Docket No.: 62795.2WO01PATIENT NARRATIVES:
[0098] Some exemplary patient narratives were collected and are provided below.
[0099] The following patients did not receive any IV fluid post-operatively.Patient Narrative - NoIV-01
[0100] Surgery: Bilateral double incision mastectomy with nipple grafts
[0101] Emergence / wake up time: This patient experienced a slower emergence, requiring extended time to regain full alertness and orientation. The transition from anesthesia was prolonged, and the patient appeared groggy well into their PACU stay.
[0102] Mental clarity / focus / brain fog: Low mental clarity was observed. The patient had difficulty maintaining focus, was intermittently disoriented, and required repeated instructions. They retained minimal memory of conversations with the nursing staff during recovery.
[0103] Nausea / Vomiting: More frequent nausea and vomiting occurred. The patient required additional doses of antiemetics and remained uncomfortable due to persistent queasiness and two episodes of emesis in the PACU.
[0104] Pain Levels in PACU: The patient reported moderate pain in recovery. They required multiple doses of pain medication to achieve acceptable comfort levels, contributing to a longer PACU stay.
[0105] PACU discharge time: Prolonged discharge was noted due to persistent grogginess, nausea, and the need for additional pain control. Discharge criteria were met later than typical for this procedure.
[0106] Mobility levels: The patient had delayed mobilization, expressing fatigue and generalized sluggishness when attempting to ambulate. Staff assistance was needed for initial movements.
[0107] Post-op infection: There were no infections observed in this case. Incision sites remained intact and clean throughout the recovery process.
[0108] Wound healing quality: Healing was described as less ideal. The surgical site appeared inflamed for longer than expected, and tissue regeneration seemed slower when compared with typical post-operative IV fluid that they received cases.
[0109] Scar formation / Keloid: Moderate scarring developed post-operatively, with areas of hypertrophy beginning to form during follow-up. The patient expressed concern about the thickness and texture of the scar tissue.
[0110] Patient satisfaction score: The patient’s satisfaction was mixed. While they were ultimately pleased with the surgical results, they noted that the recovery period was moreDocket No.: 62795.2WO01 difficult than anticipated. They expressed regret at not having access to or choosing any postoperative supportive therapies and reported lingering fatigue and discomfort well into the days following surgery.Patient Narrative - NoIV-02
[0111] Surgery: Bilateral double incision mastectomy with nipple grafts
[0112] Emergence / wake up time: This patient had a slower emergence, requiring additional time to fully wake and orient following anesthesia. The patient remained drowsy and had delayed responsiveness during the early phase of PACU recovery.
[0113] Mental clarity / focus / brain fog: Low mental clarity was observed. The patient seemed confused and disoriented, frequently forgetting recent conversations and needing multiple prompts from the PACU nursing team.
[0114] Nausea / Vomiting: Normal nausea levels were experienced. While the patient did not vomit, they did report persistent queasiness and were preemptively treated with antiemetics.
[0115] Pain Levels in PACU: High levels of pain were reported shortly after arrival to the PACU. The patient required multiple rounds of analgesics to achieve moderate relief and remained visibly uncomfortable for most of the recovery period.
[0116] PACU discharge time: Discharge was within a normal timeframe, although the patient’s pain and lingering fatigue prevented earlier release. They were cleared once pain was sufficiently managed.
[0117] Mobility levels: Normal post-operative mobility was observed. The patient ambulated cautiously with assistance but was slower and less confident than typical postoperative IV fluid that they received patients.
[0118] Post-op infection: There were no infections noted. Surgical incisions remained intact, and there was no evidence of erythema or drainage.
[0119] Wound healing quality: Healing was considered less ideal, with signs of mild tissue irritation and slower epithelial closure noted during follow-up visits.
[0120] Scar formation / Keloid: The patient developed moderate scarring, with mildly raised, firm scar lines that were of cosmetic concern to the patient during early healing.
[0121] Patient satisfaction score: The patient reported a mixed level of satisfaction. They were content with the surgical outcome itself but felt the recovery process was more taxing than expected, citing pain, fatigue, and slower return to baseline function as key frustrations. They expressed interest in exploring enhanced recovery options in the future.Patient Narrative - NoIV-03
[0122] Surgery: Bilateral double incision mastectomy with nipple graftsDocket No.: 62795.2WO01
[0123] Emergence / wake up time: The patient exhibited a slower emergence, requiring extended time to fully regain consciousness and orientation post-anesthesia. They remained lethargic for a prolonged period in the PACU before becoming alert.
[0124] Mental clarity / focus / brain fog: Medium mental clarity was observed. The patient was intermittently focused but occasionally confused or forgetful during early recovery, requiring repeated reassurance and instructions from nursing staff.
[0125] Nausea / Vomiting: The patient experienced more frequent nausea and vomiting, needing multiple doses of antiemetic medication. Episodes of vomiting extended their PACU stay and contributed to overall discomfort.
[0126] Pain Levels in PACU: Moderate pain was reported, requiring more than one dose of analgesics for adequate relief. The patient vocalized discomfort and appeared tense throughout much of the recovery period.
[0127] PACU discharge time: Discharge was prolonged due to ongoing nausea, pain management needs, and delayed return to baseline alertness. Nursing staff noted this patient as slower to meet PACU discharge criteria.
[0128] Mobility levels: Delayed mobility was observed. The patient was slow to sit up, hesitant to stand, and needed significant assistance with ambulation. Fatigue and dizziness contributed to their limited activity.
[0129] Post-op infection: There were no signs of infection during the initial recovery and follow-up assessments.
[0130] Wound healing quality: Healing was considered normal, with expected signs of progress, though without any notable acceleration in tissue recovery.
[0131] Scar formation / Keloid: Normal scarring was present. The incision line showed typical firmness and mild redness, consistent with standard healing for this type of procedure.
[0132] Patient satisfaction score: The patient reported a high level of satisfaction with their surgical outcome. However, they described the recovery period as particularly challenging due to nausea and pain. They later expressed that they would have appreciated more supportive measures to ease the post-op process, especially after seeing how others recovered more comfortably.Patient Narrative - NoIV-04
[0133] Surgery: Bilateral double incision mastectomy with nipple grafts
[0134] Emergence / wake up time: This patient had a slower emergence from anesthesia, with a sluggish return to full consciousness and responsiveness. PACU staff noted that the patient remained groggy for an extended period following extubation.Docket No.: 62795.2WO01
[0135] Mental clarity / focus / brain fog: Medium mental clarity was observed. The patient was at times coherent but also displayed signs of brain fog and mild disorientation during early recovery, requiring repeated instructions and support.
[0136] Nausea / Vomiting: More frequent nausea and vomiting occurred during PACU stay, requiring both oral and IV antiemetic treatment. These symptoms were distressing to the patient and contributed to their overall discomfort and delayed discharge readiness.
[0137] Pain Levels in PACU: Moderate pain levels were reported throughout recovery, needing multiple interventions for effective management. The patient described a deep soreness and required prolonged monitoring to reach a tolerable comfort level.
[0138] PACU discharge time: The discharge process was prolonged, with the combination of nausea and pain delaying the patient’s ability to meet clinical discharge benchmarks.
[0139] Mobility levels: Normal mobility was observed once the patient stabilized. While hesitant initially, they were eventually able to ambulate with minimal assistance before discharge.
[0140] Post-op infection: The patient unfortunately developed a mild post-operative infection at one of the graft sites, identified during the first follow-up. It required a short course of oral antibiotics and daily wound care but resolved without long-term complications.
[0141] Wound healing quality: Wound healing was considered less ideal, partly due to the infection and associated inflammation, which slowed the tissue recovery timeline.
[0142] Scar formation / Keloid: Moderate scarring was noted, including some raised and thickened tissue at the incision sites. The appearance was more pronounced than average and required topical treatment per the surgeon’s recommendation.
[0143] Patient satisfaction score: Despite the complications, the patient expressed a high level of satisfaction with the surgical outcome itself. However, they acknowledged that the recovery process was more difficult than expected, citing nausea, slower healing, and the infection as key stressors. They later expressed interest in hearing about future recoveryenhancing options.Patient Narrative - NoIV-05
[0144] Surgery: Bilateral double incision mastectomy with nipple grafts
[0145] Emergence / wake up time: The patient experienced a slower emergence from anesthesia. They remained unresponsive and drowsy longer than expected, requiring additional time in PACU before becoming alert and oriented.Docket No.: 62795.2WO01
[0146] Mental clarity / focus / brain fog: Low mental clarity was observed. The patient appeared confused and cognitively sluggish, struggling to follow instructions and engage meaningfully during the early recovery period.
[0147] Nausea / Vomiting: More frequent episodes of nausea and vomiting were reported. Anti-nausea medications provided limited relief, and the patient was visibly distressed throughout much of the PACU stay.
[0148] Pain Levels in PACU : The patient reported high pain levels, especially in the chest. Multiple doses of narcotics were required, and even then, their discomfort remained difficult to control.
[0149] PACU discharge time: Discharge occurred on a normal timeline, but only after extended efforts to manage the patient’ s nausea and pain to an acceptable threshold.
[0150] Mobility levels: Delayed mobility was noted. The patient was unable to ambulate independently in PACU and required assistance with repositioning and transitioning to sitting or standing positions.
[0151] Post-op infection: There were no signs of infection during the immediate recovery or follow-up.
[0152] Wound healing quality: Healing progressed at a normal rate. Incisions remained intact with no signs of delayed granulation or wound breakdown.
[0153] Scar formation / Keloid: The patient developed moderate scarring, including some hypertrophic thickening at the incision site. The surgeon initiated scar management measures during follow-up.
[0154] Patient satisfaction score: The patient ultimately expressed a high level of satisfaction with the aesthetic results of the surgery. However, they described the recovery as physically taxing, with persistent nausea, strong pain, and difficulty moving early on. They mentioned that the first few days were much harder than they had anticipated, and voiced interest in exploring enhanced recovery options for any future procedures.Patient Narrative - NoIV-06
[0155] Surgery: Bilateral double incision mastectomy with nipple grafts
[0156] Emergence / wake up time: This patient experienced a slower emergence from anesthesia. PACU staff noted an extended period of grogginess, with delayed eye opening and inconsistent responsiveness during the initial phase of recovery.
[0157] Mental clarity / focus / brain fog: The patient displayed medium mental clarity, regaining focus gradually. They were cooperative but required repeated prompting and reported feeling “cloudy” for a prolonged duration.Docket No.: 62795.2WO01
[0158] Nausea / Vomiting: No significant nausea or vomiting was reported. The patient tolerated oral fluids without issue and declined antiemetics.
[0159] Pain Levels in PACU: Pain levels were low in PACU. The patient required only a small dose of IV analgesia and stated that they were comfortable during most of the recovery stay.
[0160] PACU discharge time: Despite minimal pain and no nausea, the discharge process was prolonged, primarily due to the extended wake-up time and the need for observation until the patient returned to full baseline function.
[0161] Mobility levels: Early mobility was achieved. The patient was able to ambulate with minimal assistance and transferred independently to a recovery chair shortly before discharge.
[0162] Post-op infection: There were no signs of post-operative infection noted at followup. The incisions remained clean and dry.
[0163] Wound healing quality: Wound healing was considered less ideal, with some uneven healing at areola. Mild bruising and prolonged swelling contributed to a delayed aesthetic outcome.
[0164] Scar formation / Keloid: Normal scarring was observed. No keloid or hypertrophic changes were evident, but the patient was advised to begin silicone therapy as a precaution.
[0165] Patient satisfaction score: The patient expressed a mixed level of satisfaction. While they were ultimately pleased with the surgical improvements and comfort level, they commented on the slow recovery from anesthesia and unexpected post-operative swelling. They felt that their recovery experience was more difficult than anticipated and showed interest in any future options that could make recovery smoother.Patient Narrative - NoIV-07
[0166] Surgery: Bilateral double incision mastectomy with nipple grafts
[0167] Emergence / wake up time: The patient had a slower emergence from anesthesia, remaining groggy and minimally responsive for an extended period. PACU staff noted delayed verbal interaction and a longer time to return to orientation.
[0168] Mental clarity / focus / brain fog: Low mental clarity persisted through much of the PACU stay. The patient reported feeling foggy and disoriented, with difficulty following basic instructions.
[0169] Nausea / Vomiting: More frequent nausea and vomiting episodes occurred during recovery. Despite administration of antiemetic medications, the patient vomited twice in PACU and required ongoing monitoring.Docket No.: 62795.2WO01
[0170] Pain Levels in PACU: The patient reported high levels of pain, particularly at the surgical site. IV narcotics were administered in multiple doses, though pain relief was only partial, and the patient continued to rate their discomfort as significant.
[0171] PACU discharge time: Discharge was completed on a normal timeline, though only after stabilizing nausea and achieving partial pain control.
[0172] Mobility levels: Normal mobility was observed. While the patient was eventually able to ambulate with assistance, it took several attempts before they felt stable enough to do so.
[0173] Post-op infection: There were no signs of infection in the early post-operative period.
[0174] Wound healing quality: Wound healing progressed at a normal rate, though minor bruising and swelling persisted longer than expected.
[0175] Scar formation / Keloid: Moderate scarring developed along the chest incisions, with some hypertrophic characteristics. The patient was referred for topical scar therapy.
[0176] Patient satisfaction score: The patient expressed a mixed level of satisfaction. While they were content with the surgical outcome itself, they found the recovery process challenging — particularly the intense nausea, grogginess, and pain. They stated that the recovery was more difficult than they had imagined and wondered whether other patients had smoother experiences.Patient Narrative - NoIV-08
[0177] Surgery: Bilateral double incision mastectomy with nipple grafts
[0178] Emergence / wake up time: This patient had an accelerated emergence from anesthesia. They became alert and oriented sooner than most others in the NoIV group, surprising both the anesthesiologist and PACU team with how quickly they returned to baseline responsiveness.
[0179] Mental clarity / focus / brain fog: Mental clarity was medium. Although the patient was able to engage and answer questions without delay, they mentioned mild fogginess during the first hour post-op but returned to normal shortly thereafter.
[0180] Nausea / Vomiting: Normal levels of nausea were noted. The patient experienced brief queasiness without vomiting, requiring one dose of antiemetics for comfort.
[0181] Pain Levels in PACU: Moderate pain was reported. The patient requested medication within the first 20 minutes post-arrival to PACU and needed an additional dose to achieve acceptable comfort.Docket No.: 62795.2WO01
[0182] PACU discharge time: Discharge was prolonged, despite their rapid emergence. Extended monitoring was required for pain control and to ensure they maintained adequate hydration and stability before ambulating.
[0183] Mobility levels: Normal mobility was observed. The patient ambulated slowly and with assistance, reporting soreness but no dizziness or balance issues.
[0184] Post-op infection: There were no signs of infection during the post-operative course.
[0185] Wound healing quality: Normal wound healing was documented, with no complications. Bruising was mild and resolved within expected timeframes.
[0186] Scar formation / Keloid: Normal scarring was observed. Early scar formation was flat and soft without evidence of hypertrophy or keloid changes.
[0187] Patient satisfaction score: Despite a somewhat prolonged PACU stay, the patient expressed very high satisfaction with their overall experience. They felt grateful that their recovery had been smoother than they expected, especially compared to stories they’d heard from friends, and were particularly relieved to have avoided any post-op complications. They reported they would choose the same procedure again without hesitation.Patient Narrative - NoIV-09
[0188] Surgery: Bilateral double incision mastectomy with nipple grafts
[0189] Emergence / wake up time: This patient experienced a slower emergence from anesthesia, taking longer than average to open their eyes and respond appropriately to verbal cues. Recovery staff noted the patient appeared groggy and required additional time before fully orienting.
[0190] Mental clarity / focus / brain fog: Mental clarity was low. The patient remained cognitively dulled for the first hour in PACU and was unable to retain basic discharge instructions without repeated explanation.
[0191] Nausea / Vomiting: Normal levels of nausea were reported. Although no vomiting occurred, the patient felt queasy intermittently and needed a single dose of ondansetron for symptom relief.
[0192] Pain Levels in PACU: Low pain levels were noted initially, which may have contributed to the slower mobilization observed later. The patient reported mild discomfort that was manageable without multiple interventions.
[0193] PACU discharge time: Discharge was prolonged. Despite low pain and controlled nausea, the combination of sluggish emergence and delayed mobility resulted in a longer-than- expected PACU stay.Docket No.: 62795.2WO01
[0194] Mobility levels: Delayed mobility was noted. The patient required extended encouragement and assistance to achieve first ambulation, citing fatigue and hesitancy despite stable vitals.
[0195] Post-op infection: There were no signs of infection during the early post-op period.
[0196] Wound healing quality: Wound healing was assessed as less ideal, with noticeable bruising and swelling that persisted longer than in typical cases. Some delayed tissue response was also documented by the surgeon at follow-up.
[0197] Scar formation / Keloid: Minimal scarring was observed. The incisions were healing without keloid formation, though texture was uneven in areas.
[0198] Patient satisfaction score: The patient ultimately reported high satisfaction with the surgical outcome itself but shared that the recovery felt more exhausting and mentally draining than expected. They noted that although the pain was mild, the fatigue, mental fog, and healing pace were frustrating. Nevertheless, they were pleased with their cosmetic result and felt the overall experience was worth it.Patient Narrative - NoIV-10
[0199] Surgery: Bilateral double incision mastectomy with nipple grafts
[0200] Emergence / wake up time: This patient had a slower emergence from anesthesia. While vital signs remained stable, it took a longer period for them to become fully responsive and interactive, requiring additional observation during the initial phase of recovery.
[0201] Mental clarity / focus / brain fog: Mental clarity was medium. The patient communicated effectively but displayed intermittent pauses and moments of disorientation. They reported needing a bit of extra time before feeling “mentally normal” again.
[0202] Nausea / Vomiting: Rare episodes of nausea were noted. No vomiting occurred, and symptoms resolved quickly without the need for medication.
[0203] Pain Levels in PACU : High pain levels were reported shortly after arrival to P ACU. The patient needed multiple doses of analgesics to bring the discomfort under control, particularly around the surgical sites on the chest.
[0204] PACU discharge time: Discharge time was normal. Once pain and orientation were stabilized, the patient was able to meet the discharge criteria without delays.
[0205] Mobility levels: Early mobility was observed. The patient ambulated with minimal assistance and was eager to sit up and walk once permitted, despite their earlier issues with pain.
[0206] Post-op infection: There were no signs of infection noted during the early recovery period.Docket No.: 62795.2WO01
[0207] Wound healing quality: Wound healing was assessed as normal. The incisions showed appropriate progress at follow-up, with no concerns for delayed healing or wound breakdown.
[0208] Scar formation / Keloid: Moderate scarring was observed. The patient developed some firm tissue around the incision lines, and the surgeon noted early signs of hypertrophic scarring, though nothing clinically significant at that stage.
[0209] Patient satisfaction score: The patient gave a mixed satisfaction rating, expressing appreciation for the final cosmetic results but dissatisfaction with the pain and recovery experience. They commented that the first few days post-op were more difficult than anticipated, especially with managing discomfort and swelling. Overall, they felt the outcome was good, but the journey to get there was more challenging than expected.Patient Narrative - NoIV-11
[0210] Surgery: Abdominoplasty
[0211] Emergence / wake up time: This patient experienced a slower emergence from anesthesia. Despite stable vitals, the patient took longer than average to regain full consciousness and required extended PACU monitoring for orientation and responsiveness.
[0212] Mental clarity / focus / brain fog: The patient’s mental clarity was low during recovery. They appeared groggy, had difficulty concentrating, and needed repeated instructions to stay engaged. Nurses noted that the patient required reassurance and prompting to remain alert.
[0213] Nausea / Vomiting: More frequent episodes of nausea were recorded during early recovery, accompanied by two instances of vomiting. Antiemetics were administered, which provided eventual relief, but symptoms initially delayed recovery milestones.
[0214] Pain Levels in PACU: High levels of pain were reported. The patient described deep aching and tightness in the surgical areas, requiring multiple doses of IV and oral pain medication to achieve partial relief.
[0215] PACU discharge time: Despite the severity of pain and nausea, discharge time was accelerated due to scheduling constraints and the patient's desire to leave once medically cleared. However, staff noted that the patient still appeared uncomfortable at discharge.
[0216] Mobility levels: Mobility was delayed. The patient was hesitant to sit up or ambulate, citing dizziness and discomfort. Assistance was needed for initial movement, and full mobility was not achieved before leaving PACU.
[0217] Post-op infection: No signs of postoperative infection were observed during the early recovery period.Docket No.: 62795.2WO01
[0218] Wound healing quality: Healing was assessed as less ideal. Incision lines appeared inflamed, and early signs of delayed dermal remodeling were noted by the surgeon during follow-up.
[0219] Scar formation / Keloid: Scarring was within normal limits. The patient showed no signs of keloid formation, though tissue firmness around the suture lines was present.
[0220] Patient satisfaction score: The patient provided a mixed satisfaction score. While ultimately pleased with the cosmetic improvement, they were vocal about the difficulties experienced during the early recovery phase, especially the intensity of the pain and nausea. They expressed interest in whether anything could have made recovery smoother in hindsight. Patient Narrative - NoIV-12
[0221] Surgery: Abdominoplasty
[0222] Emergence / wake up time: The patient had a normal emergence from anesthesia. They became responsive in a reasonable time frame, with stable vitals and mild grogginess initially that resolved without intervention.
[0223] Mental clarity / focus / brain fog: Mental clarity was low. Although the patient was awake and oriented, they reported a lingering foggy feeling and difficulty focusing during early recovery. PACU staff noted the patient seemed withdrawn and minimally communicative.
[0224] Nausea / Vomiting: Nausea was present at a normal frequency, with no vomiting episodes reported. Standard antiemetics were given prophylactically and helped manage the symptoms.
[0225] Pain Levels in PACU: Pain levels were moderate. The patient described a dull, persistent ache in the surgical areas, particularly around the navel. Pain medication helped reduce discomfort, but relief was only partial while in PACU.
[0226] PACU discharge time: Discharge was prolonged due to ongoing discomfort and hesitation to mobilize. Nurses delayed clearance to ensure adequate pain control and patient readiness for transition home.
[0227] Mobility levels: Mobility was delayed. The patient was slow to get up and required physical assistance. They reported feeling unsteady and reluctant to ambulate for fear of triggering pain.
[0228] Post-op infection: There were no signs of infection during the immediate postoperative phase.
[0229] Wound healing quality: Healing was considered normal. The surgical sites were progressing as expected, with appropriate inflammation and no dehiscence or delayed closure.Docket No.: 62795.2WO01
[0230] Scar formation / Keloid: Moderate scarring was noted. The incision lines were raised and firm at follow-up, and early hypertrophic changes were suspected, especially around the lower abdomen.
[0231] Patient satisfaction score: The patient expressed mixed satisfaction. While they were content with the overall cosmetic result, they shared frustration about the recovery experience, particularly the pain, slow mobility, and lack of mental sharpness in the hours after surgery. They mentioned the recovery felt harder than anticipated.Patient Narrative - NoIV-1
[0232] Surgery: Abdominoplasty
[0233] Emergence / wake up time: This patient had a slower emergence from anesthesia. Although they remained hemodynamically stable, they appeared groggy and required more time than average to become fully interactive and coherent in PACU.
[0234] Mental clarity / focus / brain fog: Mental clarity was moderate. The patient could follow instructions and engage in conversation, though nurses noted they appeared distracted and slightly delayed in processing questions during the first hour of recovery.
[0235] Nausea / Vomiting: Nausea occurred at a normal rate. The patient reported a mildly unsettled stomach but did not experience any vomiting. Antiemetics were administered as part of routine care.
[0236] Pain Levels in PACU: Pain was rated as moderate. The patient described discomfort localized to the abdominal area but responded well to standard analgesia, which brought pain levels to a manageable range.
[0237] PACU discharge time: Discharge was within a normal timeframe. Once pain and alertness were stabilized, the patient met discharge benchmarks without major delay.
[0238] Mobility levels: Mobility was normal. The patient stood and walked with mild assistance and tolerated positional changes without significant issues, though not with particular eagerness.
[0239] Post-op infection: No infection was identified during the early postoperative recovery.
[0240] Wound healing quality: Wound healing was considered less ideal. The surgical sites showed mild erythema and slower-than-expected closure. Though not alarming, followup was scheduled to ensure progression.
[0241] Scar formation / Keloid: Scarring appeared normal. There was no evidence of hypertrophic or keloid formation at the time of evaluation.Docket No.: 62795.2WO01
[0242] Patient satisfaction score: The patient expressed high satisfaction with the final outcome. They felt that their cosmetic results met expectations and were pleased overall, but they did mention the recovery felt more sluggish than anticipated. They noted the healing process could have been smoother and wondered if additional support post-op might have helped.Patient Narrative - NoIV-14[0243J Surgery: Abdominoplasty
[0244] Emergen ce / Wake Up Time: This patient demonstrated a slower emergence from anesthesia. They remained groggy for a prolonged period and needed extra time before becoming fully responsive, extending the initial monitoring duration.
[0245] Mental Clarity / Focus / Brain Fog: Mental clarity was moderate. While the patient was able to respond to basic questions, they described feeling "foggy" and mentally slow for most of their time in recovery.
[0246] Nausea / Vomiting: More frequent nausea was observed during the early recovery phase. The patient required multiple doses of anti-nausea medication to manage symptoms, though no vomiting occurred.
[0247] Pain Levels in PACU: The patient reported high pain levels shortly after surgery. Analgesic support was escalated, and nursing notes indicated complaints of persistent abdominal discomfort despite standard treatment protocols.
[0248] PACU Discharge Time: Discharge occurred within a normal timeframe, but only after adequate control of pain and nausea. Staff noted that the patient was hesitant to leave until those symptoms were managed.
[0249] Mobility Levels: Mobility was within normal expectations. The patient was able to stand and take a few steps but required encouragement and assistance.
[0250] Post-op Infection: No infection was noted in the early postoperative period. Surgical sites remained clean and intact.
[0251] Wound Healing Quality: Healing was assessed as normal. There were no issues with delayed healing, though the incision edges appeared slightly inflamed, consistent with early-phase recovery.
[0252] Scar Formation / Keloid: Moderate scarring was noted on follow-up. The patient exhibited thickening along parts of the incision line, and scar modulation was discussed.
[0253] Patient Satisfaction Score: The patient reported a mixed level of satisfaction. They were pleased with the visual outcome of their abdominoplasty but voiced disappointment in the immediate recovery experience, particularly with the nausea and pain. They expressedDocket No.: 62795.2WO01 curiosity about other patients recovering more comfortably and wondered if an enhanced recovery approach could have helped.Patient Narrative - NoIV-15
[0254] Surgery: Abdominoplasty
[0255] Emergence / wake up time: The patient had a slower emergence from anesthesia, taking additional time to become fully alert and communicative. Recovery staff noted delayed responsiveness and longer drowsiness compared to typical PACU benchmarks.
[0256] Mental clarity / focus / brain fog: Mental clarity was moderate. The patient showed occasional hesitation when responding to questions and commented on feeling groggy well into the early recovery period.
[0257] Nausea / Vomiting: No nausea or vomiting occurred. Despite the slower wake-up and overall grogginess, the patient remained gastrointestinally stable and required no antiemetics.
[0258] Pain Levels in PACU: Moderate abdominal pain was reported. The patient needed two rounds of IV analgesics before discomfort subsided to a tolerable level.
[0259] PACU discharge time: Discharge was prolonged. Due to delayed emergence and pain control, additional time was needed in PACU before meeting safe discharge criteria.
[0260] Mobility levels: Mobility was delayed. The patient required extra assistance to get out of bed and expressed difficulty with core engagement due to surgical tightness and discomfort.
[0261] Post-op infection: No signs of infection were observed in the early post-op period. Incisions remained clean and without erythema or drainage.
[0262] Wound healing quality: Healing was excellent. The incision lines were described as clean, dry, and healing ahead of expected pace. No issues with separation or inflammation were noted.
[0263] Scar formation / Keloid: Scarring appeared minimal. Early scar formation was flat, with good pigment match and no indication of hypertrophic or keloid development.
[0264] Patient satisfaction score: The patient reported a very high level of satisfaction. Despite an initially sluggish recovery and delayed mobility, they were thrilled with their cosmetic outcome and especially pleased with the clean incision lines and nearly invisible scars. They expressed gratitude toward the surgical team for a smooth process and reported feeling increasingly confident as healing progressed.Patient Narrative - NoIV-16
[0265] Surgery: Breast Reconstruction / MastopexyDocket No.: 62795.2WO01
[0266] Emergence / wake up time: This patient experienced a slower emergence from anesthesia. They remained in a sedated, low-responsiveness state for an extended time after surgery, requiring close PACU monitoring and additional time before regaining full alertness.
[0267] Mental clarity / focus / brain fog: Mental clarity was moderate. Once awake, the patient appeared coherent but reported feeling foggy and mentally drained. They needed reassurance and repeated explanations of their post-op instructions.
[0268] Nausea / Vomiting: The patient experienced more frequent episodes of nausea and required multiple doses of antiemetic medication to stabilize symptoms. Although no vomiting was documented, persistent nausea negatively impacted the early recovery process.
[0269] Pain Levels in PACU: High levels of discomfort were reported, particularly at the graft and incision sites. The patient needed several rounds of analgesia and described the pain as "intense and burning" despite medication.
[0270] PACU discharge time: Discharge from PACU was prolonged. Due to both nausea and pain management delays, the patient remained in recovery longer than anticipated before meeting all safety criteria for discharge.
[0271] Mobility levels: Mobility was delayed. The patient showed reluctance to move or sit upright for extended periods, citing both discomfort and lingering dizziness as barriers to early ambulation.
[0272] Post-op infection: No evidence of infection was noted during the early postoperative period. Surgical sites remained intact with no signs of erythema or discharge.
[0273] Wound healing quality: Healing quality was assessed as less ideal. The surgeon noted some minor inflammation and slower- than- average tissue response around the incision lines at the first follow-up visit.
[0274] Scar formation / Keloid: Scarring was moderate. There was early hypertrophic development along the mastopexy incisions, with some firmness and thickening that the surgeon plans to monitor closely.
[0275] Patient satisfaction score: The patient ultimately reported a high level of satisfaction. While the recovery process was physically difficult and slower than expected, they expressed gratitude for the reconstructive outcome and felt the aesthetic improvements were worth the discomfort. They noted that, despite the bumps in recovery, they felt more confident about their body and would still choose to undergo the procedure again.Patient Narrative - NoIV-17
[0276] Surgery: Breast Reconstruction / MastopexyDocket No.: 62795.2WO01
[0277] Emergence / Wake Up Time: This patient experienced a slower-than-average emergence from anesthesia. The transition to wakefulness was prolonged, and the patient required extended monitoring before achieving full responsiveness.
[0278] Mental Clarity / Focus / Brain Fog: Mental clarity was low. Upon awakening, the patient was disoriented, required repeated verbal prompts, and struggled to maintain focus during initial communication with the PACU staff.
[0279] Nausea / Vomiting: Nausea was rare. The patient reported a mild queasiness but did not require any antiemetic intervention and experienced no episodes of vomiting.
[0280] Pain Levels in PACU: Pain levels were moderate. The patient described discomfort localized to the surgical areas and required standard pain control measures, which were moderately effective.
[0281] PACU Discharge Time: Discharge time was within normal limits. Despite the slower emergence, once pain and orientation were under control, the patient met criteria and was safely discharged from recovery without delay.
[0282] Mobility Levels: Mobility was normal. The patient ambulated with some assistance and tolerated positional changes without significant difficulty, although some stiffness was noted.
[0283] Post-op Infection: No postoperative infection was observed. Surgical sites remained clean and intact throughout the early healing period.
[0284] Wound Healing Quality: Healing was judged to be less ideal. Mild erythema and slower tissue integration were noted during early follow-up, though no signs of dehiscence or major complications were present.
[0285] Scar Formation / Keloid: Scarring was moderate. Slight hypertrophic development was visible along the incision lines, particularly near the anchor points, and will continue to be monitored over time.
[0286] Patient Satisfaction Score: The patient reported a high satisfaction score. While she acknowledged that recovery was more taxing than expected, particularly in terms of mental fog and incision discomfort, she was pleased with the reconstructive outcome and surgical aesthetics. She mentioned that although the early days were difficult, she ultimately felt the result made the process worthwhile.Patient Narrative - NoIV-18
[0287] Surgery: Breast Reconstruction / MastopexyDocket No.: 62795.2WO01
[0288] Emergence / Wake Up Time: The patient demonstrated a normal emergence from anesthesia. They became alert within the expected timeframe, though the initial moments of arousal were sluggish and required repeated verbal stimulation.
[0289] Mental Clarity / Focus / Brain Fog: Mental clarity was low. The patient appeared mentally foggy for an extended period post-op, showing difficulty with orientation and verbal engagement during early recovery.
[0290] Nausea / Vomiting: Nausea and vomiting were more frequent than typical. The patient reported persistent queasiness and experienced two distinct episodes of vomiting, requiring pharmacologic intervention to stabilize symptoms.
[0291] Pain Levels in PACU: Pain levels were high. The patient described significant discomfort and pressure in the chest area, necessitating multiple rounds of IV pain medication for relief.
[0292] PACU Discharge Time: Despite the elevated discomfort, discharge time was accelerated due to early hemodynamic stability and the patient’s insistence on continuing recovery at home. However, additional education was required to ensure safe discharge.
[0293] Mobility Levels: Mobility was delayed. The patient was hesitant to ambulate due to pain and nausea, and required considerable assistance when moving from bed to chair.
[0294] Post-op Infection: No infection was observed during the initial postoperative phase. Surgical sites were clean and without signs of inflammation or drainage.
[0295] Wound Healing Quality: Wound healing was normal. Incisions showed satisfactory tissue approximation and closure, with no early signs of dehiscence or breakdown.
[0296] Scar Formation / Keloid: Scarring was normal. The healing incisions demonstrated appropriate formation of scar tissue with no hypertrophic or keloid characteristics noted during follow-up.
[0297] Patient Satisfaction Score: The patient gave a mixed satisfaction rating. While she expressed confidence in the surgical results and long-term aesthetic goals, she felt the recovery period was unexpectedly difficult due to the persistent nausea and significant discomfort. Her comments reflected appreciation for the final outcome but acknowledged that the early postoperative experience left much to be desired.Patient Narrative - NoIV-19
[0298] Surgery: Breast Reconstruction / Mastopexy
[0299] Emergence / Wake Up Time: This patient had a slower emergence from anesthesia. They remained drowsy and minimally responsive for an extended period in PACU, requiring continuous monitoring and delayed verbal interaction.Docket No.: 62795.2WO01
[0300] Mental Clarity / Focus / Brain Fog: Mental clarity was low. The patient experienced pronounced brain fog upon awakening and reported difficulty focusing and tracking conversations during the early recovery period.
[0301] Nausea / Vomiting: The patient experienced more frequent episodes of nausea and vomiting, which prolonged their PACU stay and required antiemetic medications to control symptoms effectively.
[0302] Pain Levels in PACU: Pain levels were high. The patient reported substantial discomfort, particularly across the surgical sites, and required several doses of IV analgesia to achieve moderate relief.
[0303] PACU Discharge Time: Discharge from PACU was prolonged due to the combination of slow wake-up, significant nausea, and uncontrolled pain. Clearance for discharge occurred only after stabilization.
[0304] Mobility Levels: Early mobility was achieved, despite the difficult emergence and high pain. The patient made a strong effort to ambulate with assistance shortly after discharge criteria were met.
[0305] Post-op Infection: No infection was observed. The surgical wounds remained clean, dry, and intact with no signs of erythema, drainage, or fever.
[0306] Wound Healing Quality: Wound healing was categorized as less ideal. Though there was no infection, the incision edges showed signs of delayed tissue regeneration and mild localized inflammation on follow-up.
[0307] Scar Formation / Keloid: Scarring was normal. There was no excessive keloid or hypertrophic tissue formation, though early firmness around the incision lines was noted.
[0308] Patient Satisfaction Score: The patient reported a mixed satisfaction experience. While she was ultimately happy with the surgical outcome and appreciated the cosmetic result, the postoperative period was marred by excessive nausea, significant pain, and slow cognitive recovery. She expressed that the overall recovery process was more difficult than expected, particularly in comparison to prior surgeries.Patient Narrative - NoIV-20
[0309] Surgery: Breast Reconstruction / Mastopexy
[0310] Emergence / Wake Up Time: The patient exhibited a normal emergence from anesthesia. Vital signs remained stable and the patient became alert within an expected timeframe, requiring no special intervention.Docket No.: 62795.2WO01
[0311] Mental Clarity / Focus / Brain Fog: Mental clarity was moderate. The patient was coherent and communicative but reported mild grogginess and needed extra time before feeling fully oriented.
[0312] Nausea / Vomiting: The patient experienced more frequent nausea than average during the immediate post-op phase. Although vomiting did not occur, symptoms required pharmacologic management and extended recovery room support.
[0313] Pain Levels in PACU: Pain was rated low. The patient reported discomfort but was able to tolerate it well with minimal analgesia, which allowed the care team to avoid higher doses of medication.
[0314] PACU Discharge Time: Discharge from PACU was within a normal range. Despite the nausea, the patient recovered physical and cognitive baselines in a timely manner and met the criteria for transfer.
[0315] Mobility Levels: Mobility was delayed. While not severely restricted, the patient needed extended rest before attempting to ambulate and required moderate assistance during early mobilization.
[0316] Post-op Infection: There were no signs of infection. Incisions remained clean with no redness, discharge, or signs of systemic inflammation throughout follow-up.
[0317] Wound Healing Quality: Wound healing was assessed as normal. Sutures remained intact and the skin showed gradual and expected tissue regeneration without complications.
[0318] Scar Formation / Keloid: Scarring was also categorized as normal. There were no visible signs of keloid or hypertrophic changes, and healing was consistent with typical postoperative expectations.
[0319] Patient Satisfaction Score: The patient reported a high level of satisfaction. While she noted issues with nausea and slower mobility than expected, she expressed confidence in her surgical outcome and gratitude for the overall care. She commented that her recovery would have been even smoother with additional support during the early postoperative hours.Patient Narrative - NoIV-21
[0320] Surgery: Facelift / Neck Lift
[0321] Emergence / Wake Up Time: The patient's emergence from anesthesia was within a normal timeframe. They regained consciousness and responsiveness without complications but did not exhibit the accelerated clarity seen in some other cases.
[0322] Mental Clarity / Focus / Brain Fog: Mental clarity was low. The patient reported lingering fogginess and struggled to fully engage during the early stages of recovery. ThisDocket No.: 62795.2WO01 limited their interaction with staff immediately post-op and delayed their subjective return to baseline.
[0323] Nausea / Vomiting: The patient experienced normal levels of nausea, without vomiting. Symptoms were mild but persistent enough to require routine antiemetic administration.
[0324] Pain Levels in PACU: Pain levels were high. The patient required multiple doses of analgesics to gain relief, particularly noting discomfort around the jawline and neck areas where the surgical manipulation was most extensive.
[0325] PACU Discharge Time: Discharge was prolonged due to the combined impact of low mental clarity and pain. Nursing staff had to extend observation to ensure that the patient met all discharge criteria safely.
[0326] Mobility Levels: Mobility was within normal expectations. The patient was slow but steady in achieving initial ambulation and required modest assistance during first movement attempts.
[0327] Post-op Infection: No signs of postoperative infection were observed. The surgical sites remained free of inflammation, discharge, or systemic symptoms.
[0328] Wound Healing Quality: Healing was rated as less ideal. Although there was no infection, the incisions showed slight delay in epithelialization and remained more inflamed than expected during the initial recovery window.
[0329] Scar Formation / Keloid: Scarring was moderate, with early thickening noted along portions of the incision lines. The patient was advised on scar management techniques during follow-up.
[0330] Patient Satisfaction Score: This patient expressed mixed satisfaction. They were pleased with the surgical results but reported frustration with the early recovery experience, particularly due to lingering brain fog, pain, and slower healing. They expressed interest in exploring additional postoperative support options should they undergo future procedures.Patient Narrative - NoIV-22
[0331] Surgery: Facelift / Neck Lift
[0332] Emergence / Wake Up Time: This patient had a slower emergence from anesthesia. While they maintained stable vitals, their return to full responsiveness took longer than average, with grogginess persisting through much of the early PACU phase.
[0333] Mental Clarity / Focus / Brain Fog: Mental clarity was low. The patient experienced significant fogginess and delayed cognitive function. They were quiet and disengaged early on and noted that it took several hours to “feel like themselves again.”Docket No.: 62795.2WO01
[0334] Nausea / Vomiting: Nausea was within a normal expected range for the procedure. Although not severe, the patient required antiemetic support to prevent progression of symptoms. No vomiting was reported.
[0335] Pain Levels in PACU: Pain was moderate and localized to the surgical areas. The patient rated their discomfort as manageable with standard analgesic regimens and did not request additional medication beyond routine orders.
[0336] PACU Discharge Time: Discharge occurred at a normal pace. Once their nausea and pain were controlled, the patient met PACU discharge benchmarks without delay.
[0337] Mobility Levels: Mobility was delayed. Despite stable vitals and improving symptoms, the patient was hesitant to ambulate early and required more encouragement and support to mobilize compared to peers.
[0338] Post-op Infection: A postoperative infection was documented. The patient presented with localized redness and mild serous drainage at the lower facelift incision site during their first follow-up visit. Oral antibiotics were prescribed, and the issue resolved without escalation.
[0339] Wound Healing Quality: Healing was considered normal. Despite the minor infection, the tissues responded appropriately to treatment, and no significant disruption of the healing process occurred.
[0340] Scar Formation / Keloid: Scarring was moderate. Incision lines developed early firmness and hyperpigmentation, with visible thickening suggestive of hypertrophic response.
[0341] Patient Satisfaction Score: Despite a slower recovery and a mild infection, this patient reported a very high level of satisfaction. They were extremely pleased with the final aesthetic outcome and felt the surgeon delivered excellent results. They described the post-op course as “expected” and expressed that they would undergo the procedure again if needed. Patient Narrative - NoIV-23
[0342] Surgery: Facelift / Neck Lift
[0343] Emergence / Wake Up Time: The patient experienced a slower emergence from anesthesia. Recovery of consciousness was prolonged, and additional time in PACU was required before the patient became fully alert and oriented.
[0344] Mental Clarity / Focus / Brain Fog: Mental clarity was moderate. While the patient was able to communicate, they reported feeling groggy and mentally sluggish throughout the remainder of the day. This sensation lingered into the evening hours post-surgery.Docket No.: 62795.2WO01
[0345] Nausea / Vomiting: More frequent episodes of nausea occurred during the early post-operative period. The patient required multiple doses of anti-nausea medication and expressed difficulty managing the discomfort in PACU.
[0346] Pain Levels in PACU: Pain was reported as high, with persistent discomfort around the facial and neck surgical sites. The patient needed more than one round of pain medication to gain relief and expressed visible distress at times.
[0347] PACU Discharge Time: Discharge from PACU was prolonged due to the combined effects of nausea, pain, and slower mental recovery. Nursing staff extended observation time to ensure safe transition to home care.
[0348] Mobility Levels: Mobility was delayed. The patient required assistance to sit upright and did not ambulate independently until much later than typical for this procedure.
[0349] Post-op Infection: No signs of infection were observed during the follow-up period. The incisions remained clean and dry with no evidence of systemic or localized complications.
[0350] Wound Healing Quality: Wound healing was excellent. Incisions appeared to be progressing rapidly with minimal inflammation or scabbing, and the surgeon commented on the favorable healing trajectory.
[0351] Scar Formation / Keloid: Scarring was assessed as normal. The incision lines remained flat and were beginning to fade appropriately with early post-op scar management in place.
[0352] Patient Satisfaction Score: The patient expressed a mixed satisfaction score. They were very happy with the cosmetic results and the surgeon's work but expressed frustration with the initial recovery experience. The combination of nausea, pain, and mental fog made the first few days difficult. Despite this, they acknowledged the end result as worth the discomfort.Patient Narrative - NoIV-24
[0353] Surgery: Facelift / Neck Lift
[0354] Emergence / Wake Up Time: The emergence from anesthesia was slower than average. The patient took longer than expected to become fully responsive and required extra time for orientation in the PACU.
[0355] Mental Clarity / Focus / Brain Fog: Mental clarity was moderate. The patient was conversational but reported some lingering fogginess and a delayed sense of mental sharpness during the initial recovery period.
[0356] Nausea / Vomiting: The patient experienced no significant nausea or vomiting. Mild queasiness was noted but resolved without intervention and did not hinder recovery.Docket No.: 62795.2WO01
[0357] Pain Levels in PACU: Pain levels in PACU were moderate. The patient required analgesics to manage the discomfort but responded well to treatment and did not require escalation of therapy.
[0358] PACU Discharge Time: Despite the slower emergence and moderate pain, the discharge time was accelerated. The patient met discharge criteria more quickly than expected once symptoms were managed.
[0359] Mobility Levels: Mobility was normal. The patient was able to sit up and ambulate within a typical timeframe post-surgery, requiring minimal assistance.
[0360] Post-op Infection: There were no signs of infection during the post-operative period. The surgical sites remained intact with no redness, drainage, or systemic symptoms.
[0361] Wound Healing Quality: Wound healing was assessed as less ideal. Although there was no infection, the incisions appeared mildly inflamed and slower to close compared to other patients, prompting conservative follow-up measures.
[0362] Scar Formation / Keloid: Scarring was judged to be within normal expectations. Some firmness around incision lines was noted, but no hypertrophic or keloid tendencies were observed at this stage.
[0363] Patient Satisfaction Score: The patient reported a high level of satisfaction. While the recovery process was described as "not the easiest," they felt the surgical results were well worth the discomfort. They appreciated the attentive care but expressed curiosity about whether an enhanced recovery approach — like IV supplementation — might have made things smoother. Patient Narrative - NoIV-25
[0364] Surgery: Facelift / Neck Lift
[0365] Emergence / Wake Up Time: The patient experienced a slower emergence from anesthesia. Initial responsiveness was delayed, requiring extended monitoring before achieving full orientation.
[0366] Mental Clarity / Focus / Brain Fog: Mental clarity was moderate. The patient was able to communicate effectively but reported a sense of grogginess and slower cognitive processing that lingered into the early recovery phase.
[0367] Nausea / Vomiting: More frequent episodes of nausea were documented in the immediate post-op period. Antiemetics were administered to control symptoms, and the patient described feeling “queasy” well into the first few hours after surgery.
[0368] Pain Levels in PACU: Moderate pain was reported in PACU. The patient received multiple doses of analgesics to achieve adequate relief, particularly for deep tissue discomfort around the surgical sites.Docket No.: 62795.2WO01
[0369] PACU Discharge Time: Discharge was prolonged. Due to the combination of slower emergence and need for ongoing symptom control, the patient required extended time in PACU before safely meeting discharge criteria.
[0370] Mobility Levels: Mobility was delayed. The patient was slow to sit up and hesitant to ambulate without significant assistance, likely due to lingering discomfort and nausea.
[0371] Post-op Infection: There were no signs of post-operative infection. The incision sites remained clean, with no drainage or redness observed.
[0372] Wound Healing Quality: Wound healing was within normal expectations. At follow-up, the incisions were progressing well, though some mild edema was still present.
[0373] Scar Formation / Keloid: Moderate scarring was noted during follow-up. The patient showed early signs of hypertrophic scarring, particularly along the neckline, though no revision was indicated at the time.
[0374] Patient Satisfaction Score: The patient gave a mixed satisfaction rating. While pleased with the aesthetic result, they expressed frustration with the initial post-op experience, especially the persistent nausea and pain. They wondered aloud whether enhanced recovery techniques, such as IV-based support, might have improved their outcome.
[0375] Patient narratives: The following patients received Version 2 of IV fluid post-operatively.
[0376] Patient Narrative - Version 2-01
[0377] Surgery: Bilateral double incision mastectomy with nipple grafts
[0378] Emergence / Wake Up Time: Emergence from anesthesia was normal. The patient regained consciousness without delay and transitioned smoothly from a sedated state to full awareness, following standard recovery timelines.
[0379] Mental Clarity / Focus / Brain Fog: The patient demonstrated high mental clarity postoperatively. They were fully alert, conversant, and responsive within a short time of waking, with no signs of confusion or cognitive delay.
[0380] Nausea / Vomiting: Nausea was within normal limits. The patient experienced brief queasiness early in PACU but did not require antiemetic intervention, and there were no episodes of vomiting.
[0381] Pain Levels in PACU: Pain was reported as low. Mild discomfort around the surgical site was effectively managed with the standard initial dose of analgesics, and no additional pain medications were requested.Docket No.: 62795.2WO01
[0382] PACU Discharge Time: Discharge timing was normal. The patient met standard PACU discharge criteria within the usual observation window, requiring no extensions or additional interventions.
[0383] Mobility Levels: Mobility was also within the normal range. The patient followed standard postoperative milestones for sitting up and ambulating with minimal assistance by nursing staff.
[0384] Post-op Infection: There were no signs of postoperative infection. Surgical sites remained clean, dry, and intact during follow-up assessments.
[0385] Wound Healing Quality: Healing was excellent. The incisions showed early epithelialization and strong wound edge approximation, with no concerns for delayed recovery or tissue stress.
[0386] Scar Formation / Keloid: Scar formation was minimal. The patient demonstrated favorable tissue remodeling with thin, flat incision lines and no evidence of hypertrophic or keloid scarring.
[0387] Patient Satisfaction Score: The patient reported a very high level of satisfaction. They noted that their recovery felt unusually smooth and efficient and believed the postoperative IV fluid that they received played a key role in their minimal pain, rapid healing, and clear-headed recovery. They expressed that they would strongly recommend the IV therapy to others undergoing similar surgery.Patient Narrative - Version 2-02
[0388] Surgery: Bilateral double incision mastectomy with nipple grafts
[0389] Emergence / Wake Up Time: The patient had a normal emergence from anesthesia.They regained consciousness at a typical pace, following expected post-anesthesia protocols without requiring any prolonged monitoring.
[0390] Mental Clarity / Focus / Brain Fog: Mental clarity was rated as high. The patient reported feeling mentally sharp soon after waking and was able to engage in conversation clearly and coherently without any lingering confusion or fogginess.
[0391] Nausea / Vomiting: Nausea was rare in this case. The patient reported only a slight queasy sensation shortly after awakening but did not require any medication, and symptoms resolved quickly.
[0392] Pain Levels in PACU: Pain levels were low. The patient reported mild discomfort, which was well-managed with a standard analgesic dose. No additional intervention was needed, and the patient remained comfortable throughout the PACU stay.Docket No.: 62795.2WO01
[0393] PACU Discharge Time: The discharge from PACU was accelerated. The patient met all criteria early and was cleared for transfer ahead of typical timing, aided by their stable vitals and overall rapid recovery.
[0394] Mobility Levels: Early mobility was observed. The patient stood and ambulated with assistance sooner than expected, showing initiative and comfort in moving despite the nature of their procedure.
[0395] Post-op Infection: There were no signs of infection noted during the early recovery period. The surgical sites remained clean and intact without redness, drainage, or concern.
[0396] Wound Healing Quality: Healing was assessed as normal. The incisions were progressing well, with no signs of delayed healing or tissue breakdown. Healing followed the expected trajectory for this type of surgery.
[0397] Scar Formation / Keloid: Scar development was within normal expectations. Incision lines were flat and soft at follow-up with no indications of hypertrophic or keloid response.
[0398] Patient Satisfaction Score: The patient expressed a high level of satisfaction with their surgical recovery. They felt that the post-operative IV fluid that they received gave them a noticeable edge — especially in how mentally clear and physically stable they felt shortly after surgery. They appreciated the minimal pain and early mobility, stating the recovery exceeded their expectations.Patient Narrative - Version 2-03
[0399] Surgery: Bilateral double incision mastectomy with nipple grafts
[0400] Emergence / Wake Up Time: The patient experienced an accelerated emergence from anesthesia. They regained consciousness unusually quickly and were alert and responsive within minutes of arriving in the recovery room.
[0401] Mental Clarity / Focus / Brain Fog: Mental clarity was rated as low. Despite a fast wake-up, the patient reported feeling mentally foggy for a while, with delayed processing and a need for extended quiet time before regaining their full cognitive baseline.
[0402] Nausea / Vomiting: Nausea was rare. The patient did not report any significant nausea or vomiting, and antiemetics were not required at any point during recovery.
[0403] Pain Levels in PACU: Pain levels were high upon arrival to PACU. The patient reported sharp and persistent discomfort at the surgical sites. Multiple doses of analgesics were necessary to reach acceptable pain control levels.Docket No.: 62795.2WO01
[0404] PACU Discharge Time: Discharge from PACU was prolonged. Due to the initial pain intensity and the time required to ensure the patient was comfortable and oriented, they remained under observation longer than expected.
[0405] Mobility Levels: Despite challenges in PACU, the patient achieved early mobility. They were able to sit up and ambulate with assistance not long after transfer, demonstrating good physical recovery readiness.
[0406] Post-op Infection: No signs of infection were noted. Surgical incisions remained clean and intact, and there was no fever, redness, or drainage reported in early follow-up.
[0407] Wound Healing Quality: Wound healing was excellent. Incisions progressed with no complications, and early signs pointed to strong tissue repair and integration of the nipple grafts.
[0408] Scar Formation / Keloid: Scar formation was minimal. The incision lines were fine and smooth at follow-up, with no early signs of abnormal scarring or keloid activity.
[0409] Patient Satisfaction Score: The patient expressed a very high level of satisfaction with their recovery. Although they experienced a difficult pain phase early on, they felt that the post-operative IV fluid that they received played a key role in accelerating their emergence and supporting rapid wound healing. They stated they felt stronger than expected just a day after surgery and were surprised by how clean and healthy the incision sites looked so early in recovery.Patient Narrative - Version 2-04
[0410] Surgery: Bilateral double incision mastectomy with nipple grafts
[0411] Emergence / Wake Up Time: This patient experienced an accelerated emergence from anesthesia. They were responsive and cooperative within minutes of arrival to PACU, requiring minimal prompting to orient themselves.
[0412] Mental Clarity / Focus / Brain Fog: Mental clarity was high. The patient described feeling mentally sharp and alert shortly after waking, with clear speech and an ability to follow instructions without hesitation.
[0413] Nausea / Vomiting: Nausea was reported as normal. The patient had mild waves of queasiness but did not require intervention and had no episodes of vomiting.
[0414] Pain Levels in PACU: Pain in the recovery area was low. The patient tolerated the initial post-operative period well and required only standard, minimal pain management for comfort.Docket No.: 62795.2WO01
[0415] PACU Discharge Time: Discharge was accelerated. The patient met recovery milestones quickly and was able to transition out of PACU ahead of schedule without complications.
[0416] Mobility Levels: Early mobility was achieved. The patient was up and walking under supervision not long after PACU discharge and demonstrated confidence in moving independently.
[0417] Post-op Infection: No signs of infection were observed during follow-up. The surgical sites remained free of redness, swelling, or drainage.
[0418] Wound Healing Quality: Wound healing was rated as less ideal. Although the incisions remained intact, the appearance of the tissue showed early signs of mild delayed healing, such as slight crusting or slower epithelialization.
[0419] Scar Formation I Keloid: Moderate scarring developed. The patient showed signs of thicker scar tissue forming, particularly around the lateral incision edges, consistent with early hypertrophic changes.
[0420] Patient Satisfaction Score: The patient reported a high level of satisfaction with their recovery. They credited the post-operative IV fluid that they received for helping them feel awake and balanced post-operatively and for minimizing discomfort. While they acknowledged some concerns about the scar visibility and slower-than-expected healing of the incisions, they felt their energy levels and pain control made the overall experience a positive one.Patient Narrative - Version 2-05
[0421] Surgery: Bilateral double incision mastectomy with nipple grafts
[0422] Emergence / Wake Up Time: The patient had an accelerated emergence from anesthesia, becoming alert and interactive quickly after arrival in PACU. They required minimal verbal stimulation to regain full orientation.
[0423] Mental Clarity / Focus / Brain Fog: Mental clarity was moderate. While the patient was awake and responsive, they described feeling slightly “foggy” for a short period following emergence, which resolved by the time they left the recovery area.
[0424] Nausea / Vomiting: Nausea was rare. The patient denied any persistent queasiness and did not require antiemetics, with no vomiting episodes recorded.
[0425] Pain Levels in PACU: Pain was moderate in the immediate post-operative period. The patient required one additional dose of analgesics for comfort but maintained manageable pain levels throughout recovery.Docket No.: 62795.2WO01
[0426] PACU Discharge Time: Discharge from PACU was within the normal timeframe. The patient met criteria at a typical pace, following stabilization of vital signs and effective pain management.
[0427] Mobility Levels: Mobility was delayed. While vital signs and pain control were appropriate, the patient experienced some hesitancy and stiffness, requiring additional time before ambulating comfortably.
[0428] Post-op Infection: There were no signs of infection at any point during recovery. Incisions remained clean and dry.
[0429] Wound Healing Quality: Wound healing was excellent. Follow-up visits revealed healthy granulation tissue and well- pproximated incisions with no complications.
[0430] Scar Formation / Keloid: Scarring was minimal. The incisions were flat and healing evenly, with no evidence of hypertrophy or keloid development.
[0431] Patient Satisfaction Score: The patient expressed a very high level of satisfaction with their recovery. They shared that the post-operative IV fluid that they received made a noticeable difference in how alert and steady they felt after surgery. Despite some early discomfort and delayed mobility, they were thrilled with their energy levels and surgical healing. They said they felt “like themselves” within a day and would enthusiastically recommend the IV drip to others undergoing similar procedures.Patient Narrative - Version 2-06
[0432] Surgery: Bilateral double incision mastectomy with nipple grafts
[0433] Emergence / Wake Up Time: The patient experienced a normal emergence from anesthesia. They regained consciousness and orientation within the expected time range, requiring standard monitoring and support.
[0434] Mental Clarity / Focus / Brain Fog: Mental clarity was high. The patient reported feeling mentally sharp and alert shortly after waking, without the typical post-anesthesia grogginess that many expect.
[0435] Nausea / Vomiting: More frequent episodes of nausea were observed postoperatively. The patient required medication to manage symptoms, though no vomiting was documented, and the nausea resolved within a few hours.
[0436] Pain Levels in PACU: Pain was rated as moderate. The patient reported discomfort around the chest area, which was effectively managed with a combination of IV and oral analgesics during their stay in PACU.Docket No.: 62795.2WO01
[0437] PACU Discharge Time: Discharge was accelerated. Despite experiencing nausea and moderate pain, the patient met all recovery criteria efficiently and was cleared for discharge sooner than average.
[0438] Mobility Levels: Mobility was early. The patient was eager to get up and move shortly after surgery and tolerated ambulation well with minimal assistance.
[0439] Post-op Infection: No infection was observed. The surgical sites remained clean and intact throughout the recovery process.
[0440] Wound Healing Quality: Healing was excellent. Incisions showed strong epithelialization and minimal inflammation, consistent with optimal post-op healing.
[0441] Scar Formation / Keloid: Scarring was minimal. Follow-up assessments noted smooth and flat incisions with no hypertrophic changes.
[0442] Patient Satisfaction Score: The patient reported a high level of satisfaction with their surgical experience and recovery. They felt that the post-operative IV fluid that they received contributed significantly to their mental clarity and healing, despite the early nausea. They emphasized how quickly they were able to resume light activities and praised the recovery team for helping them feel well taken care of.Patient Narrative - Version 2-07
[0443] Surgery: Bilateral double incision mastectomy with nipple grafts
[0444] Emergence / Wake Up Time: This patient had an accelerated emergence from anesthesia. They became responsive and communicative more quickly than the average recovery timeline, requiring minimal prompting or intervention.
[0445] Mental Clarity / Focus / Brain Fog: Mental clarity was moderate. The patient was generally coherent and communicative but mentioned feeling a bit foggy in the initial minutes of recovery. This resolved quickly as they became more oriented.
[0446] Nausea / Vomiting: Nausea was rare. The patient reported only a mild queasiness that resolved on its own without medication, and no vomiting occurred.
[0447] Pain Levels in PACU: Pain was low in the PACU. The patient described their discomfort as mild and was managed effectively with standard analgesic protocols, requiring only minimal intervention.
[0448] PACU Discharge Time: Discharge from the recovery unit was accelerated. Due to stable vitals, low pain, and early alertness, the patient was able to meet discharge milestones efficiently and without delay.Docket No.: 62795.2WO01
[0449] Mobility Levels: Mobility was early. The patient was able to sit up and walk with minimal assistance shortly after surgery and was eager to begin light movement soon after arriving home.
[0450] Post-op Infection: No signs of infection were observed throughout the early postoperative period.
[0451] Wound Healing Quality: Healing was normal. The surgical incisions progressed appropriately with no signs of wound breakdown or delayed epithelialization.
[0452] Scar Formation / Keloid: Scarring was normal. The incision lines showed standard healing patterns, and there was no evidence of abnormal scar formation or keloid development at follow-up.
[0453] Patient Satisfaction Score: The patient expressed a high level of satisfaction with their overall recovery. They credited the post-operative IV fluid that they received with helping them feel comfortable and well-prepared in the immediate postoperative phase. While they did mention feeling slightly foggy at first, they were grateful for how manageable their recovery felt and would recommend the IV to others undergoing similar surgery.Patient Narrative - Version 2-08
[0454] Surgery: Bilateral double incision mastectomy with nipple grafts
[0455] Emergence / wake up time: The patient emerged rapidly from anesthesia, with early signs of alertness and stable vitals shortly after entering the PACU. The recovery team noted a smooth and efficient transition.
[0456] Mental clarity / focus / brain fog: Mental clarity was high. The patient was alert, articulate, and able to engage clearly with PACU staff within minutes of waking up.
[0457] Nausea / Vomiting: Nausea was within normal range. The patient reported some queasiness but did not vomit and did not require antiemetic medication.
[0458] Pain Levels in PACU: Pain was reported as high during the initial recovery phase. The patient required a full dose of postoperative analgesia, which successfully brought their discomfort under control.
[0459] PACU discharge time: Despite elevated pain levels, the patient was discharged on an accelerated timeline after stabilizing quickly and meeting all discharge criteria.
[0460] Mobility levels: Mobility was within normal limits. The patient sat up and ambulated independently with a standard level of assistance and pacing.
[0461] Post-op infection: No postoperative infection was noted by the surgical team.
[0462] Wound healing quality: Wound healing was normal at the one-week follow-up.Incisions appeared clean and intact with expected signs of healing.Docket No.: 62795.2WO01
[0463] Scar formation / Keloid: Minimal scarring was observed. The incision lines were thin, healing well, and showed no signs of keloid or hypertrophic changes.
[0464] Patient satisfaction score: The patient gave a very high satisfaction score, describing the post-operative IV fluid that they received as a “total recovery booster.” They noted that, despite initial pain, they felt energetic and alert and said the drip made their experience “so much better than previous surgeries.”Patient Narrative - Version 2-09
[0465] Surgery: Bilateral double incision mastectomy with nipple grafts
[0466] Emergence / wake up time: The patient experienced an accelerated emergence from anesthesia, regaining consciousness quickly and without complications shortly after PACU admission.
[0467] Mental clarity / focus / brain fog: Mental clarity was medium. The patient was alert but slightly less engaged than others in the post-operative IV fluid that they received group. They followed commands and answered questions but remained somewhat quiet.
[0468] Nausea / Vomiting: Nausea was rare. The patient did not experience vomiting and did not require any anti-nausea medication during recovery.
[0469] Pain Levels in PACU: Pain was medium. The patient rated their discomfort as tolerable and was given a standard dose of analgesic, which provided adequate relief.
[0470] PACU discharge time: Discharge occurred within a normal timeframe. The patient met recovery milestones as expected without any delays.
[0471] Mobility levels: Post-op mobility was early. The patient stood up and walked with minimal support and expressed confidence in their ability to move around.
[0472] Post-op infection: No infection was observed during the postoperative period.
[0473] Wound healing quality: Healing was excellent. The incisions showed clean, healthy recovery with no signs of delayed tissue response.
[0474] Scar formation / Keloid: Scarring was minimal. The patient’s incision lines were narrow and flat with no thickening or discoloration.
[0475] Patient satisfaction score: The patient gave a mixed satisfaction score. While they appreciated the fast recovery and excellent wound healing, they felt the overall experience was “average” due to persistent discomfort and described the benefit as helpful, but not dramatic.Patient Narrative - Version 2-10
[0476] Surgery: Bilateral double incision mastectomy with nipple graftsDocket No.: 62795.2WO01
[0477] Emergence / Wake Up Time: The patient experienced a normal emergence from anesthesia, regaining consciousness and orientation without complication. They became responsive in a reasonable time frame with no need for pharmacologic reversal or extended monitoring.
[0478] Mental Clarity / Focus / Brain Fog: Mental clarity was moderate. The patient was able to carry on conversation and follow commands but noted feeling slightly “off’ mentally for the first hour post-op. This improved steadily without the need for additional support.
[0479] Nausea / Vomiting: Nausea was rare. There were no episodes of vomiting, and the patient required no antiemetic medications in recovery.
[0480] Pain Levels in PACU: Pain was low. The patient reported mild discomfort that was promptly treated with a single dose of standard analgesics, with no breakthrough pain observed thereafter.
[0481] PACU Discharge Time: Discharge was accelerated. Due to stable vitals, low pain, and a cooperative demeanor, the patient was cleared for discharge ahead of schedule.
[0482] Mobility Levels: Early mobility was achieved. The patient was able to ambulate with minimal assistance and demonstrated steady coordination when transitioning from bed to standing.
[0483] Post-op Infection: No infection was noted during follow-up. The patient’s incisions remained clean and well-approximated throughout the initial recovery period.
[0484] Wound Healing Quality: Healing was excellent. The incision sites demonstrated rapid tissue regeneration and no complications, with healthy granulation and minimal scab formation.
[0485] Scar Formation / Keloid: Scarring appeared normal. The patient’s skin responded well to closure, with no early signs of hypertrophic or keloid development.
[0486] Patient Satisfaction Score: The patient reported very high satisfaction, stating that the recovery process felt smoother than expected. They were especially surprised by how minimal their discomfort was, and they appreciated the post-operative IV fluid’s role in supporting a calm, focused recovery. They described the overall experience as “surprisingly easy” and expressed interest in receiving the IV again for any future procedures.Patient Narrative - Version 2-11
[0487] Surgery: Abdominoplasty
[0488] Emergence / Wake Up Time: This patient experienced an accelerated emergence from anesthesia, becoming alert and responsive more quickly than typically expected following abdominoplasty. There was no need for extended observation beyond standard protocol.Docket No.: 62795.2WO01
[0489] Mental Clarity / Focus / Brain Fog: Mental clarity was moderate. The patient communicated clearly and responded appropriately but noted feeling slightly “foggy” for the first portion of recovery. These symptoms resolved on their own without intervention.
[0490] Nausea / Vomiting: Nausea was rare. No vomiting occurred, and no antiemetics were required in the recovery room.
[0491] Pain Levels in PACU: Pain was low and well-managed. The patient reported minimal discomfort, which was easily controlled with a conservative dose of analgesia. They remained calm and cooperative throughout PACU stay.
[0492] PACU Discharge Time: Discharge occurred within a normal timeframe. While not unusually early, the patient met all standard discharge criteria without delay or complication.
[0493] Mobility Levels: Mobility was within the normal range. The patient stood and walked with assistance per postoperative protocol, tolerating activity without dizziness or excessive fatigue.
[0494] Post-op Infection: No infection was noted. The surgical site remained clean with no signs of erythema, drainage, or dehiscence at early follow-up.
[0495] Wound Healing Quality: Wound healing was assessed as normal. The incision sites showed expected progress without complications or delays.
[0496] Scar Formation / Keloid: Minimal scarring was observed. The healing process was smooth, with thin, well-aligned scars and no hypertrophic or keloid changes noted.
[0497] Patient Satisfaction Score: The patient expressed very high satisfaction with their recovery experience. They highlighted the ease of waking up from anesthesia and the noticeable absence of nausea or significant pain. The patient felt that the post-operative IV fluid that they received played a key role in setting the tone for a smoother post-op course and would strongly recommend it to others undergoing similar procedures.Patient Narrative - Version 2-12
[0498] Surgery: Abdominoplasty
[0499] Emergence / Wake Up Time: The patient demonstrated an accelerated emergence from anesthesia, waking up quickly, oriented, and responsive. This smooth transition required minimal PACU intervention and allowed the team to begin early postoperative assessments promptly.
[0500] Mental Clarity / Focus / Brain Fog: Mental clarity was high. The patient appeared mentally sharp, asking coherent questions about their surgery and demonstrating excellent memory recall during their PACU stay.Docket No.: 62795.2WO01
[0501] Nausea / Vomiting: Nausea was rare. The patient denied any feelings of queasiness, and no vomiting occurred. No antiemetics were needed during recovery.
[0502] Pain Levels in PACU: Pain levels were low. The patient described only mild discomfort, which was effectively controlled with a single dose of analgesics without the need for escalation.
[0503] PACU Discharge Time: Discharge time was accelerated. Due to stable vitals, low pain, and high mental alertness, the patient was discharged from PACU ahead of typical benchmarks for abdominoplasty cases.
[0504] Mobility Levels: Mobility was early. The patient ambulated with assistance shortly after PACU discharge, tolerating upright movement well and reporting minimal dizziness or fatigue.
[0505] Post-op Infection: There were no signs of postoperative infection. The surgical site remained clean and intact throughout the early healing period.
[0506] Wound Healing Quality: Wound healing was excellent. Tissue regeneration was rapid, and early follow-up showed healthy skin approximation with no concerns for delayed healing or breakdown.
[0507] Scar Formation / Keloid: Scarring was minimal. The incision lines were flat, light in color, and well-aligned, showing no hypertrophic or keloid tendencies.
[0508] Patient Satisfaction Score: The patient reported a mixed level of satisfaction. While they were highly pleased with the anesthesia recovery and overall healing progress, they expressed some concerns about residual tightness and abdominal discomfort common in early abdominoplasty recovery. Despite this, they stated they were very grateful for having opted into the post-operative IV fluid that they received, especially noting the mental clarity and lack of nausea as major benefits.Patient Narrative - Version 2-13
[0509] Surgery: Abdominoplasty
[0510] Emergence / Wake Up Time: This patient experienced an accelerated emergence from anesthesia, regaining full consciousness quickly and without any signs of disorientation. Their responsiveness in PACU allowed for early assessments and a seamless transition into recovery care.
[0511] Mental Clarity / Focus / Brain Fog: Mental clarity was high. The patient was alert, coherent, and able to engage in conversation clearly. There was no evidence of confusion or fogginess, and the patient was oriented to time and place throughout PACU.Docket No.: 62795.2WO01
[0512] Nausea / Vomiting: Nausea was rare, and the patient denied any postoperative queasiness or need for antiemetic medication. The absence of gastrointestinal discomfort contributed to a smoother PACU course.
[0513] Pain Levels in PACU: Pain was rated as low. The patient described mild pressure and tightness around the abdominal area, typical of abdominoplasty, but did not require more than standard pain control measures.
[0514] PACU Discharge Time: Discharge time was accelerated. The patient's stable vital signs, low pain, and excellent alertness allowed them to meet all criteria for early PACU discharge with no delays.
[0515] Mobility Levels: Mobility was initiated early. The patient stood and ambulated with minimal assistance and reported feeling surprisingly steady on their feet for the first postoperative walk.
[0516] Post-op Infection: No infection was noted. The surgical site appeared clean and intact, with appropriate wound edges and no drainage or inflammation.
[0517] Wound Healing Quality: Healing was normal. The incisions demonstrated timely epithelialization and acceptable wound strength during early follow-up.
[0518] Scar Formation I Keloid: Scarring was normal. While there was expected tissue firmness around the incision line, it remained within the usual range for this type of surgery, with no signs of hypertrophic scarring.
[0519] Patient Satisfaction Score: The patient expressed very high satisfaction with their overall recovery. They emphasized how easy it was to wake up from anesthesia, the lack of nausea, and how quickly they were able to move post-op. The patient noted this recovery was far better than their prior experiences with surgery and credited the post-operative IV fluid that they received as a significant contributing factor to how well they felt both physically and mentally.Patient Narrative - Version 2-14
[0520] Surgery: Abdominoplasty
[0521] Emergence / Wake Up Time: The patient experienced an accelerated emergence from anesthesia, opening their eyes and following commands soon after arriving in PACU. There were no delays in regaining consciousness, and the transition to wakefulness was smooth.Docket No.: 62795.2WO01
[0522] Mental Clarity / Focus / B rain Fog: Mental clarity was low. Although the patient was responsive, they appeared groggy and somewhat withdrawn for the first part of their recovery. They needed repeated prompting during assessments and were less communicative than average.
[0523] Nausea / Vomiting: Nausea was rare. The patient mentioned a very mild wave of queasiness but did not require anti-nausea medications and did not vomit.
[0524] Pain Levels in PACU: Pain levels were moderate. The patient described a consistent aching discomfort in the abdomen, which was controlled after two rounds of analgesics. They rated their pain as tolerable but noted it peaked during initial movement.
[0525] PACU Discharge Time: Discharge time was normal. After adequate pain management and improved alertness, the patient met standard PACU criteria and was discharged without delay.
[0526] Mobility Levels: Mobility was early. Despite earlier grogginess, the patient was able to ambulate with assistance shortly after PACU discharge and tolerated upright positioning without complaint.
[0527] Post-op Infection: No signs of infection were noted. The surgical area was clean with intact sutures, and there was no erythema or drainage.
[0528] Wound Healing Quality: Wound healing was excellent. The incision sites demonstrated robust epithelialization, with early signs of optimal tissue regeneration and no concerns at follow-up.
[0529] Scar Formation / Keloid: Scarring was minimal. The abdominal incision was flat and well-approximated, showing no signs of hypertrophy or raised edges.
[0530] Patient Satisfaction Score: The patient reported very high satisfaction with their recovery process. While they recalled a bit of grogginess early on, they felt that their overall experience was smoother than expected. They attributed the lack of nausea and their strong healing progress to the post-operative IV fluid that they received, expressing that they would confidently choose it again for any future surgery.Patient Narrative - Version 2-15
[0531] Surgery: Abdominoplasty
[0532] Emergence / Wake Up Time: This patient had a slower emergence from anesthesia. While they remained hemodynamically stable throughout, it took additional time for them to fully regain consciousness and respond consistently to verbal cues in PACU.Docket No.: 62795.2WO01
[0533] Mental Clarity / Focus / Brain Fog: Mental clarity was moderate. The patient answered questions appropriately but reported feeling mentally “foggy” for a while. They were cooperative but mentioned their thoughts felt a little sluggish initially.
[0534] Nausea / Vomiting: Nausea was rare. The patient experienced a brief sensation of queasiness but did not require any intervention and reported resolution without medication.
[0535] Pain Levels in PACU: Pain was low. The patient described only mild discomfort localized to the abdomen and responded well to routine pain management with minimal need for rescue medications.
[0536] PACU Discharge Time: Discharge was on a normal timeline. Although wake-up was slightly delayed, once fully alert and comfortable, the patient met standard criteria for PACU discharge without complications.
[0537] Mobility Levels: Mobility was within normal expectations. The patient was able to sit up and ambulate with support during the standard recovery timeframe, showing no delay but also not exhibiting unusually rapid mobilization.
[0538] Post-op Infection: No signs of infection were observed. The surgical site appeared intact and clean at early postoperative assessment.
[0539] Wound Healing Quality: Wound healing was normal. There was appropriate closure of the incision, and the healing trajectory followed expected patterns for this surgery.
[0540] Scar Formation / Keloid: Scarring was moderate. The abdominal incision showed early signs of firm, raised tissue along portions of the scar line, consistent with mild hypertrophic scar formation, though still within acceptable limits.
[0541] Patient Satisfaction Score: The patient reported high satisfaction with their surgical and recovery experience. While they felt that the initial emergence was slower than ideal, they were pleased with the lack of nausea and low pain throughout recovery. They credited the postoperative IV fluid that they received with helping their healing stay on track and noted that they felt supported and stronger than expected by the second postoperative day.Patient Narrative - Version 2-16
[0542] Surgery: Breast Reconstruction / Mastopexy
[0543] Emergence / Wake Up Time: The patient experienced an accelerated emergence from anesthesia, regaining consciousness quickly and demonstrating appropriate responses within minutes of arriving in the PACU. Their early wakefulness allowed for a smoother transition into recovery.Docket No.: 62795.2WO01
[0544] Mental Clarity / Focus / Brain Fog: Mental clarity was high. The patient was alert, oriented, and engaged in conversation shortly after waking. They retained full awareness of their surroundings and were able to recall instructions and events clearly.
[0545] Nausea / Vomiting: Nausea was rare. The patient reported feeling slightly unsettled initially but did not require any anti-emetic medications and had no vomiting episodes.
[0546] Pain Levels in PACU: Pain levels were low. The patient reported minimal discomfort localized to the surgical area, which responded well to initial dosing of analgesics. No additional pain management was needed during the PACU stay.
[0547] PACU Discharge Time: PACU discharge was accelerated. Given the patient’s stable vitals, minimal pain, and clear mental status, they were able to meet all discharge criteria more quickly than average.
[0548] Mobility Levels: Early mobility was noted. The patient stood and ambulated with minimal assistance shortly after transfer to recovery, demonstrating strong energy and cooperation.
[0549] Post-op Infection: There were no signs of infection. The surgical sites were intact, clean, and dry on inspection.
[0550] Wound Healing Quality: Wound healing was excellent. At follow-up, the incisions showed healthy tissue regeneration with no signs of inflammation or delayed closure.
[0551] Scar Formation I Keloid: Scarring was minimal. The healing incisions were thin, flat, and well-approximated, with no evidence of raised or discolored tissue.
[0552] Patient Satisfaction Score: The patient reported high satisfaction with their recovery experience. They felt significantly better than expected after surgery and credited the post-operative IV fluid that they received for supporting their healing and preventing the usual grogginess and discomfort they had experienced with prior surgeries. They described the IV as a meaningful part of their post-op care and were grateful for the improved recovery quality it provided.Patient Narrative - Version 2-17
[0553] Surgery: Breast Reconstruction / Mastopexy
[0554] Emergence / W ake Up Time: The patient had a normal emergence from anesthesia. They woke up within the typical time window and demonstrated steady improvement in alertness without complications.
[0555] Mental Clarity / Focus / Brain Fog: Mental clarity was high. The patient was sharp, conversational, and fully oriented shortly after waking. They retained clear memory of post-op instructions and communicated effectively with the PACU team.Docket No.: 62795.2WO01
[0556] Nausea / Vomiting: Nausea was more frequent than usual. Despite receiving the post-operative IV fluid that they received, the patient required anti-emetic treatment for intermittent nausea episodes in PACU, though no vomiting occurred and symptoms were controlled quickly.
[0557] Pain Levels in PACU: Pain was low. The patient reported only mild discomfort, managed effectively with routine analgesics, requiring no escalation of care.
[0558] PACU Discharge Time: PACU discharge was accelerated. With stable vital signs, controlled symptoms, and clear mentation, the patient was discharged sooner than the standard timeframe.
[0559] Mobility Levels: Early mobility was achieved. The patient stood and walked with assistance shortly after arrival in the recovery area, without notable dizziness or instability.
[0560] Post-op Infection: There were no signs of infection. The surgical sites remained clean and intact during the early post-op period.
[0561] Wound Healing Quality: Wound healing was excellent. The incisions were healing smoothly with healthy tissue appearance and no signs of inflammation or delayed closure.
[0562] Scar Formation I Keloid: Scarring was normal. At follow-up, the incision lines were soft and flat with expected post-op pigmentation, showing no signs of hypertrophy or keloid.
[0563] Patient Satisfaction Score: The patient reported very high satisfaction with their surgical recovery. They expressed gratitude for the smooth and comfortable healing process, and while they experienced some nausea, they felt the post-operative IV fluid that they received made a notable difference in their overall alertness, wound healing, and energy levels post-op. They stated that they “felt like themselves” much faster than anticipated.Patient Narrative - Version 2- 18
[0564] Surgery: Breast Reconstruction / Mastopexy
[0565] Emergence / Wake Up Time: The patient demonstrated an accelerated emergence from anesthesia. They regained consciousness quickly and responded to verbal cues with minimal delay, showing strong initial recovery parameters.
[0566] Mental Clarity / Focus / Brain Fog: Mental clarity was medium. The patient was oriented and communicative, though there were some brief moments of slowed responses and mild cognitive lag, which resolved gradually during their PACU stay.
[0567] Nausea / Vomiting: Nausea was rare. The patient reported a mild queasiness early on, but it resolved on its own without requiring any additional medications, and no vomiting episodes were noted.Docket No.: 62795.2WO01
[0568] Pain Levels in PACU: Pain was high. The patient experienced significant discomfort at the surgical sites, requiring multiple doses of analgesia to manage symptoms and achieve comfort prior to discharge.
[0569] PACU Discharge Time: Discharge from PACU was prolonged. Due to the need for enhanced pain control and extended monitoring, the patient remained in recovery longer than average before meeting discharge criteria.
[0570] Mobility Levels: Early mobility was achieved. Despite the challenges with pain, the patient was motivated and able to ambulate with light assistance shortly after clearance from the nursing staff.
[0571] Post-op Infection: There were no signs of infection. Surgical sites remained intact and free from any redness, drainage, or swelling during the initial recovery period.
[0572] Wound Healing Quality: Wound healing was excellent. At follow-up, tissue regeneration was progressing smoothly, and the surgical incisions were well-approximated with no complications.
[0573] Scar Formation / Keloid: Scarring was minimal. Early signs suggested fine, flat incisions with little to no thickening, and the surgical team noted no signs of hypertrophic changes.
[0574] Patient Satisfaction Score: The patient expressed very high satisfaction with their post-op recovery, despite the initial pain. They credited the post-operative IV fluid that they received for helping them feel more awake, alert, and functional far sooner than expected. They were particularly impressed by how quickly they regained energy and reported feeling significantly better than they had after previous surgeries without the IV, calling it a key factor in their smoother recovery this time.Patient Narrative - Version 2-19
[0575] Surgery: Breast Reconstruction / Mastopexy
[0576] Emergence / Wake Up Time: The patient experienced a normal emergence from anesthesia. They regained consciousness within the expected timeframe and responded to verbal stimuli appropriately, with no delays or complications noted.
[0577] Mental Clarity / Focus / Brain Fog: Mental clarity was high. The patient appeared sharp and fully oriented shortly after waking, easily engaging in conversation and understanding instructions provided by the PACU staff.
[0578] Nausea / Vomiting: Nausea was rare. A brief sensation of queasiness was reported but resolved spontaneously without intervention. No vomiting occurred, and the patient remained comfortable throughout recovery.Docket No.: 62795.2WO01
[0579] Pain Levels in PACU: Pain was low. Mild discomfort was reported and effectively managed with standard post-op analgesics. No additional interventions were required.
[0580] PACU Discharge Time: Discharge time was normal. The patient met all recovery benchmarks without delay and was cleared for discharge on schedule following a stable and uneventful PACU course.
[0581] Mobility Levels: Early mobility was achieved. The patient stood and walked with minimal assistance during their PACU stay and tolerated movement well without lightheadedness or nausea.
[0582] Post-op Infection: There were no signs of infection during the immediate recovery period. Surgical sites remained clean, dry, and intact with no redness or discharge noted.
[0583] Wound Healing Quality: Wound healing was normal. The incisions showed steady progress, and the tissues appeared to be healing without complications or concern for delayed recovery.
[0584] Scar Formation / Keloid: Scarring was normal. The incision lines showed no abnormal tissue buildup, and the healing was consistent with standard postoperative expectations for this procedure.
[0585] Patient Satisfaction Score: The patient expressed very high satisfaction with their surgical and recovery experience. They felt that the post-operative IV fluid that they received played a meaningful role in reducing grogginess, improving early mobility, and helping them feel more stable and alert much sooner than expected. While their recovery was generally smooth, they emphasized that this experience stood out compared to previous surgeries without the IV drip and strongly supported offering it to others undergoing similar procedures.Patient Narrative - IV-20
[0586] Surgery: Breast Reconstruction / Mastopexy
[0587] Emergence / Wake Up Time: This patient had an accelerated emergence from anesthesia. They regained consciousness rapidly and showed prompt responsiveness, requiring minimal stimulation to become fully alert in the PACU.
[0588] Mental Clarity / Focus / Brain Fog: Mental clarity was medium. The patient was generally coherent and responsive but described feeling “a little cloudy” for a short period after waking up, which gradually cleared as recovery progressed.
[0589] Nausea / Vomiting: Nausea was rare. The patient mentioned a brief wave of queasiness but it resolved quickly without medication and no episodes of vomiting were observed.Docket No.: 62795.2WO01
[0590] Pain Levels in PACU: Pain was moderate. Discomfort was concentrated around the surgical site and required routine analgesics to achieve an acceptable level of control. No escalation in pain treatment was necessary.
[0591] PACU Discharge Time: Discharge was accelerated. The patient met all clinical benchmarks for discharge ahead of typical timeframes and showed strong early signs of stabilization and readiness for home recovery.
[0592] Mobility Levels: Early mobility was observed. The patient was able to ambulate with assistance and demonstrated good coordination and tolerance to movement shortly after PACU clearance.
[0593] Post-op Infection: No signs of infection were present. The surgical areas remained clean and showed no signs of redness, drainage, or irritation during the initial post-op period.
[0594] Wound Healing Quality: Wound healing was excellent. Incisions were well- approximated, with no signs of tissue stress, breakdown, or delayed epithelialization noted at follow-up.
[0595] Scar Formation I Keloid: Scarring was minimal. The incision sites appeared to be healing smoothly with fine lines and no indications of hypertrophic or keloid tissue.
[0596] Patient Satisfaction Score: The patient reported high satisfaction with their overall surgical and recovery experience. They noted the post-operative IV fluid that they received contributed to their rapid emergence and early stability, and although they did experience some moderate pain, they were grateful for how quickly they felt functional. They described their recovery as smoother and more manageable than expected, and they stated they would choose the IV therapy again in future procedures.Patient Narrative - Version 2-21
[0597] Surgery: Facelift / Neck Lift
[0598] Emergence / Wake Up Time: The patient experienced an accelerated emergence from anesthesia. They woke up quickly and transitioned smoothly into the recovery phase, demonstrating stable vital signs and full orientation soon after arrival in the PACU.
[0599] Mental Clarity / Focus / Brain Fog: Mental clarity was high. The patient appeared alert and articulate, engaging in conversation and processing information with ease. Nurses noted their remarkable sharpness so soon after surgery.
[0600] Nausea / Vomiting: Nausea was rare, with no vomiting episodes reported. The patient described feeling “slightly queasy” early on, but symptoms resolved without requiring antiemetics.Docket No.: 62795.2WO01
[0601] Pain Levels in PACU: Pain was described as moderate, particularly around the surgical sites. The discomfort was well-managed with standard analgesic protocols and did not hinder early recovery milestones.
[0602] PACU Discharge Time: Discharge was normal. The patient met all required recovery benchmarks and was cleared to leave within the expected time window.
[0603] Mobility Levels: Mobility was normal. The patient was able to sit up, walk to the restroom, and transition to a wheelchair without excessive dizziness or instability, following the typical recovery timeline.
[0604] Post-op Infection: There were no signs of infection. The incisions remained clean, and there was no redness, warmth, or drainage on examination.
[0605] Wound Healing Quality: Wound healing was excellent. The surgical sites demonstrated healthy tissue recovery with no complications. Early follow-ups confirmed the incisions were progressing better than average.
[0606] Scar Formation I Keloid: Scarring was minimal. The patient’s incision lines were thin and flat, with no evidence of hypertrophic or keloid tissue development.
[0607] Patient Satisfaction Score: The patient reported very high satisfaction with both the surgical outcome and recovery process. They expressed that the post-operative IV fluid that they received made a noticeable difference, helping them feel “clear-headed and strong” much sooner than expected. They were particularly impressed with their lack of grogginess and how quickly they were able to resume light activity. The patient stated they would absolutely recommend the IV therapy to anyone considering surgery.Patient Narrative - Version 2-22
[0608] Surgery: Facelift / Neck Lift
[0609] Emergence / Wake Up Time: The patient experienced an accelerated emergence from anesthesia. They regained consciousness quickly and were able to follow commands and engage in conversation without delay.
[0610] Mental Clarity / Focus / Brain Fog: Mental clarity was medium. The patient was coherent and able to communicate effectively, though they described feeling a bit “slow” mentally for the first 30-45 minutes before returning to full clarity.
[0611] Nausea / Vomiting: Nausea was rare, and there were no episodes of vomiting. The patient felt mildly unsettled early on but did not require any medication for symptom relief.
[0612] Pain Levels in PACU: Pain levels were low. The patient reported only mild discomfort and required minimal analgesics, which helped them remain relaxed and calm in the PACU.Docket No.: 62795.2WO01
[0613] PACU Discharge Time: Discharge was accelerated. The patient met recovery milestones efficiently and was cleared for discharge well within the lower end of expected PACU times.
[0614] Mobility Levels: Early mobility was noted. The patient sat up and walked with minimal assistance shortly after recovery, showing good coordination and energy levels.
[0615] Post-op Infection: There were no signs of infection during the early post-op period. The surgical sites remained intact and free of redness or drainage.
[0616] Wound Healing Quality: Wound healing was assessed as normal. While not unusually rapid, the healing process was on track with expected timelines, with no complications or signs of delay.
[0617] Scar Formation / Keloid: Scarring was minimal. Incision lines were healing cleanly, with no signs of thickening or keloid formation.
[0618] Patient Satisfaction Score: The patient expressed high satisfaction with their surgical experience and recovery. They believed that the post-operative IV fluid that they received made a positive impact, particularly in minimizing their pain and improving their ability to get moving early. While they didn’t feel “amazing” right away, they noticed a smoother and more stable recovery compared to previous surgeries they’d had without IV therapy.Patient Narrative - Version 2-23
[0619] Surgery: Facelift / Neck Lift
[0620] Emergence / Wake Up Time: The patient had an accelerated emergence from anesthesia. They became alert and responsive shortly after extubation, showing clear signs of cognitive readiness faster than expected.
[0621] Mental Clarity / Focus / Brain Fog: Mental clarity was high. The patient demonstrated strong focus and awareness, engaging easily in conversation with the PACU staff and recalling instructions clearly.
[0622] Nausea / Vomiting: Nausea was rare, with no vomiting observed. The patient described a mild queasy sensation upon waking that resolved quickly without medication.
[0623] Pain Levels in PACU: Pain was moderate in intensity. The patient required a standard dose of pain medication and responded well, achieving acceptable comfort levels within 30 minutes of arrival in PACU.
[0624] PACU Discharge Time: Discharge time was normal. The patient met recovery benchmarks within the standard time range and was cleared after demonstrating adequate pain control and mobility.Docket No.: 62795.2WO01
[0625] Mobility Levels: Mobility was normal. The patient was able to sit upright and walk with assistance without dizziness or instability, though they moved a bit more cautiously than others who received the IV.
[0626] Post-op Infection: There were no signs of infection noted. Surgical incisions remained clean and dry during the early recovery phase.
[0627] Wound Healing Quality: Wound healing was excellent. Tissue approximation appeared ideal, and the surgeon noted healthy early healing during follow-up with no concerns.
[0628] Scar Formation / Keloid: Scarring was normal. The incisions were smooth and flat, healing within expected parameters with no indications of hypertrophic or keloid changes.
[0629] Patient Satisfaction Score: The patient reported very high satisfaction with their recovery and the overall experience. They specifically praised the post-operative IV fluid that they received for helping them feel clear-headed and emotionally steady during what could have been a stressful recovery. They commented that even with some pain, they felt physically stronger and believed the IV played a major role in improving their comfort and overall outcome.Patient Narrative - Version 2-24
[0630] Surgery: Facelift / Neck Lift
[0631] Emergence / Wake Up Time: The patient had a normal emergence from anesthesia. They regained consciousness smoothly and steadily without requiring prolonged observation or additional interventions.
[0632] Mental Clarity / Focus / Brain Fog: Mental clarity was assessed as high. The patient was articulate, engaged, and cognitively sharp shortly after awakening, with no signs of confusion or brain fog.
[0633] Nausea / Vomiting: Nausea was normal, presenting briefly and mildly. The patient described a subtle wave of queasiness, which resolved on its own without the need for antiemetics.
[0634] Pain Levels in PACU: The patient experienced low pain levels. Mild discomfort was easily managed with a single standard dose of pain medication, and the patient remained comfortable throughout their PACU stay.
[0635] PACU Discharge Time: Discharge time was accelerated. The patient met all recovery milestones quickly and was cleared for discharge earlier than average, with stable vitals and strong mobility.Docket No.: 62795.2WO01
[0636] Mobility Levels: Mobility was early. The patient stood and walked with confidence, showing no signs of weakness or imbalance, and expressed eagerness to begin recovery at home.
[0637] Post-op Infection: There were no infections reported. The incision sites remained clean, dry, and free of inflammation or signs of contamination.
[0638] Wound Healing Quality: Wound healing was normal. The recovery process was appropriate for the surgery type, with no abnormalities in healing speed or tissue response noted.
[0639] Scar Formation I Keloid: Scarring was minimal. Incisions were healing smoothly with soft, thin lines and no signs of hypertrophic or keloid development.
[0640] Patient Satisfaction Score: The patient reported very high satisfaction with their recovery experience. They attributed much of their positive outcome to the post-operative IV fluid that they received, noting that they felt “more like themselves” soon after surgery. They appreciated the rapid mental recovery and minimal discomfort and expressed that they would strongly recommend the IV to others undergoing similar procedures.Patient Narrative - Version 2-25
[0641] Surgery: Facelift / Neck Lift
[0642] Emergence / Wake Up Time: The patient experienced an accelerated emergence from anesthesia. They awoke quickly and required minimal prompting or observation time before becoming alert and communicative.
[0643] Mental Clarity / Focus / Brain Fog: Mental clarity was medium. While the patient was oriented and responsive, they reported a brief period of mild fogginess which resolved within the first hour of recovery.
[0644] Nausea / Vomiting: Nausea was rare. A slight wave of nausea was noted early in recovery but did not require treatment and did not recur.
[0645] Pain Levels in PACU: Pain was low in the immediate postoperative period. The patient requested a single dose of analgesia and remained comfortable for the duration of their PACU stay.
[0646] PACU Discharge Time: Discharge time was accelerated. The patient progressed efficiently through recovery milestones and was cleared for discharge sooner than the average recovery timeline.
[0647] Mobility Levels: Mobility was normal. The patient ambulated within the expected timeframe and was stable and steady with minimal assistance.Docket No.: 62795.2WO01
[0648] Post-op Infection: No signs of infection were noted during the early recovery period. The surgical sites remained intact and well-approximated.
[0649] Wound Healing Quality: Wound healing was normal, showing expected progress at follow-up with no delays or tissue complications observed.
[0650] Scar Formation I Keloid: Scarring was normal. The incisions were healing well with soft, flat tissue development and no concerning signs of hypertrophy or keloid formation.
[0651] Patient Satisfaction Score: The patient reported very high satisfaction with their surgical experience and recovery. They remarked that they felt much more stable and functional than they had anticipated following a facial procedure. The post-operative IV fluid that they received was seen as a key component of their recovery, helping them return to normal activities faster and with greater comfort.RESULTS
[0652] Patients who received Version 2 and Version 3 were observed to have less scarring, less nausea, more mental clarity, better wound healing, and experienced better post-op mobility and an accelerated emergence time and PACU discharge time compared to those who received Version 1 or no IV drip.
[0653] Patients who received B-Complex, B-12, Vitamin C and zinc had better surgical outcomes compared to those who did not receive a post-operative drip (FIGs. 1-10). Types of surgeries did not correlate to the benefits observed with the IV drip (data not shown).
[0654] Patients who received arginine and glutamine had better surgical outcomes compared to those who did not (compare Version 3 and Version 2 to Version 1 and no IV drip (FIGs. 1-10)
[0655] The removal of biotin from the IV drips (compare Version 3 to Version 2) did not significantly change the beneficial outcomes observed (FIGs. 1-10).
Claims
Docket No.: 62795.2WO01CLAIMSWHAT IS CLAIMED IS:
1. A composition for mitigating post-surgical inflammation, scarring, and risk of infection comprising an aqueous mixture of a B-Complex, wherein theB-Complex comprises:B 1 -Thiamine HydrochlorideB2- Riboflavin 5’ Phosphate SodiumB6- Pyridoxine HydrochlorideB5- DexpanthenolB3- Niacinamide;Vitamin C;Vitamin B-12;Arginine;L-Glutamine;Biotin; andZinc.
2. The composition of claim 1 wherein: the B-Complex is present in an amount ranging from 1ml - 30ml; the Vitamin C is present in an amount ranging from 50mg to 30,000mg; the Vitamin B-12 is present as either cyanocobalamin or hydroxocobalamin and present in an amount ranging from 500mcg - 60,000mcg; the Arginine is present in an amount ranging from 50mg - lOgm; the L-Glutamine is present in an amount ranging from lOmg - 20gm; the Biotin is present in an amount ranging from Img - 200mg; and the Zinc is present in an amount ranging from Img - lOOmg.
3. The composition of claim 2, wherein in the B-Complex, the Bl-Thiamine Hydrochloride is present in an amount of approximately 300mg; the B2- Riboflavin 5’ Phosphate Sodium is present in an amount of approximately 6mg; the B6- Pyridoxine Hydrochloride is present in an amount of approximately 6mg; the B5- Dexpanthenol is present in an amount of approximately 6mg; and the B3- Niacinamide is present in an amount of approximately 300mg.
4. The composition of claim 2 wherein: the Vitamin C is present in an amount of approximately 1500-3000mg;Docket No.: 62795.2WO01 the Vitamin B-12 is present in an amount of approximately 2000-5000mcg; the Arginine is present in an amount of approximately 100-200mg; the L-Glutamine is present in an amount of approximately 25-50mg; the Biotin is present in an amount of approximately 10-20mg; and the Zinc is present in an amount of approximately 10-20mg.
5. The composition of claim 2 wherein the composition is mixed with a suitable intravenous carrier.
6. A method for mitigating post-surgical inflammation, scarring, and risk of infection comprising intravenously administering a composition comprising: an aqueous mixture of a B-Complex, where the B-Complex comprises:B 1 -Thiamine HydrochlorideB2- Riboflavin 5’ Phosphate SodiumB6- Pyridoxine HydrochlorideB5- DexpanthenolB3- Niacinamide;Vitamin C;Vitamin B-12;Arginine;L-Glutamine;Biotin; andZinc.
7. A composition, comprising: an aqueous mixture of a B-Complex, where the B-Complex comprises:B 1 -Thiamine HydrochlorideB2- Riboflavin 5’ Phosphate SodiumB6- Pyridoxine HydrochlorideB5- DexpanthenolB3- Niacinamide;Vitamin C;Vitamin B-12; andZinc.
8. The composition of claim 7, wherein the composition comprises about 3 mg / ml Vitamin Bl and / or Vitamin B3.Docket No.: 62795.2WO019. The composition of claim 7 or claim 8, wherein the composition comprises about 0.06 mg / mlVitamin B2, Vitamin B6, and / or Vitamin B5.
10. The composition of any one of claims 7-9, wherein the composition comprises about 15 mg / ml Vitamin C.
11. The composition of any one of claims 7-10, wherein the composition comprises about 20 pg / ml Vitamin B-12.
12. The composition of claim of any one of claims 7-11, wherein the composition comprises about 0.1 mg / ml zinc.
13. The composition of any one of claims 7-12, wherein the composition further comprises glutathione and / or NAD+.
14. The composition of any one of claims 7-13, wherein the composition further comprises arginine.
15. The composition of claim 14, wherein the arginine is about 1 mg / ml arginine.
16. The composition of any one of claims 7-15, wherein the composition further comprises glutamine.
17. The composition of claim 16, wherein the glutamine comprises 0.25 mg / ml L-glutamine.
18. The composition of any one of claims 6-17, wherein the composition comprises biotin.
19. The composition of claim 18, wherein the composition comprises 0.1 mg / ml biotin.
20. A method of decreasing, ameliorating, or mitigating at least one negative effect of anesthesia, wherein the method comprises administering the composition of claim 7 to a patient in need thereof.
21. A method of decreasing, ameliorating, or mitigating at least one complication of a surgical procedure, wherein the method comprises administering the composition of claim 7 to a patient in need thereof.
22. The method of claim 20, wherein the at least one complication of anesthesia comprises grogginess, loss of mental clarity, loss of alertness, delayed emergence from anesthesia, and brain fog.
23. The method of claim 21, wherein the at least one complication of the surgical procedure comprises nausea, decreased immunity, increased risk of infection, deep vein thrombosis, scarring, and pain.
24. The method of claim 23, wherein the decreased immunity is a local infection or a systemic infection.
25. The method of any one of claims 20-24, wherein the composition decreases or reduces administration of a second medicament to the patient.Docket No.: 62795.2WO0126. The method of any one of claims 20-24, wherein the patient does not receive a second medicament.
27. The method of claim 25 or claim 26, wherein the second medicament comprises an antinausea medication, an analgesic, an antiviral, or an antibiotic.
28. The method of any one of claims 20-27, wherein the patient: has an emergence / wake up time score of accelerated, normal, or prolonged / slower; has a mental clarity score of high, medium, or low; has a nausea / vomiting score of frequent, normal, or rare; has a pain level in PACU score of low, medium, or high; has a PACU discharge time score of accelerated, normal, or prolonged; has a postoperative mobility score of early, normal, or delayed; has a postoperative infection score of infection or none; has a wound healing quality score of excellent, normal, or less ideal; has a scar formation / keloid score of minimal, normal, or moderate; or has a patient satisfaction score of very high, high, or mixed.
29. The method of any one of claims 20-28, wherein the patient is a human.
30. The method of any one of claims 21 or 23-29, wherein the surgical procedure is an inpatient procedure or an out-patient procedure.
31. The method of any one of claims 21 or 23-30, wherein the patient is administered an anesthetic.
32. The method of any one of claims 20, 22, or 25-31, wherein the anesthetic is a general anesthetic.
33. The method of claim 32, wherein the general anesthetic is propofol.
34. The method of any one of claims 20, 22, or 25-33, wherein the anesthetic is administered intravenously.
35. The method of any one of claims 20, 22, or 25-34, wherein the anesthetic is administered with an adjunct medication.
36. The method of claim 28, wherein the patient has one or more better scores compared to a patient who did not receive IV fluid post-operatively.
37. The method of claim 28, wherein the patient has one or more better scores compared to a patient who did not receive IV fluid comprising arginine and glutamine post-operatively.
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