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Non-invasive method for prediction of opioid-analgesia and opioid-blood-concentrations

An opioid, blood drug concentration technology, applied in the field of medical treatment such as pain therapy equipment, can solve problems such as undetermined

Inactive Publication Date: 2015-12-09
FRAUNHOFER GESELLSCHAFT ZUR FOERDERUNG DER ANGEWANDTEN FORSCHUNG EV
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

However, it has not been established whether the miotic effect of opioids is appropriate to draw conclusions about clinically relevant effects of opioids

Method used

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  • Non-invasive method for prediction of opioid-analgesia and opioid-blood-concentrations
  • Non-invasive method for prediction of opioid-analgesia and opioid-blood-concentrations
  • Non-invasive method for prediction of opioid-analgesia and opioid-blood-concentrations

Examples

Experimental program
Comparison scheme
Effect test

Embodiment

[0060] material method

[0061] subjects

[0062] Sixteen volunteers (aged 19-36 years, all within ±10% of their normal body weight, 8 males) participated in this double-blind, randomized, single-session study. Subjects were determined to be healthy by examining medical history, current physiological status and routine clinical laboratory tests and abstained from prescription / over-the-counter drugs, alcohol and food 30 days, 24 hours and 6 hours before the experiment, respectively. Effect measures and clinical effects were assessed in this order: visual acuity (duration: 5 min), clinical indices (1 min), pupil size and response to light stimulation (5 min), analgesic effect and accompanying tracking performance assessment (20 min). Non-redundant supplementary data for this study to existing analyzes are published in ( Another case in (Oertel et al., 2001) and (Oertel et al., 2012b).

[0063] medication

[0064] Remifentanil ( Provided via GlaxoWellcome GmbH & Co., Hambu...

Embodiment I

[0078] Embodiment 1: the prediction of substitute to remifentanil blood drug concentration

[0079] Data were derived from 14 subjects with three dropouts (at target concentrations of 1.8, 2.4 and 6 ng / ml) and only one replacement (1.8 ng / ml). Two subjects withdrew early from the trial, one because of anxiety that began shortly after the remifentanil infusion, and the other because of excessive vomiting and nausea. The third dropout was a medical decision to stop the remifentanil infusion due to bradycardia.

[0080] Table 1 : Nonparametric Spearman rank correlation matrix for opioid effect measures (n=14; percent change in effect measure from baseline that served as the basis for this nonparametric correlation analysis). Correlation coefficients ρ are given with respective p-values.

[0081]

[0082] *: Significant nonparametric rank correlations from this table do not imply that pain can be predicted from plasma concentrations using a linear relationship between arteria...

Embodiment II

[0085] Example II: Prediction of Analgesia by Surrogates

[0086] In the second part of the analysis, the use of surrogates to predict more clinically relevant remifentanil effects, particularly analgesia, was analyzed. Two subjects at zero concentration and subjects with hyperalgesia (23% increase in pain score from 25 to 30.7 mm VAS at a steady state plasma concentration of 2.1 ng / ml, target 1.8 ng / ml) formed a separate cluster and exclude them. Prediction of analgesic effect based on observed plasma concentrations of remifentanil (E max = -100% and EC 50 = 2.4 ng / ml; again, these values ​​have been obtained using the standard inverse model: EC 50 The estimated standard error of 4, E max not significantly different from the value -100% and thus determined, and R 2 0.274) provides an RMSE of 23%. E. max In the model, the observed concentration was replaced by the predicted concentration based on the magnitude of the pupillary light reflex, and the resulting RMSE was 50...

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Abstract

The present invention pertains to a non-invasive method and apparatus for predicting or monitoring analgesia and blood levels of opioid drugs in a patient receiving pain treatment, e.g., during palliative treatment. The inventive method comprises the measurement of one or more, preferably two or more, surrogate markers of a patient. According to the present invention surrogate markers correlate with the level of analgesia in the opioid receiving subject and thus provide a non-invasive method to predict and monitor analgesia during a treatment. Even more, surrogate markers were identified which correlate with the blood-concentration of the opioid in the subject. Thus, the invention provides a valuable clinical tool to assess and control pain treatments with opioids. Disclosed is the prediction method, an apparatus suitable for performing the inventive methods as well as the apparatus for use in medical treatments, such as pain therapy.

Description

technical field [0001] The present invention relates to non-invasive methods and devices for predicting or monitoring analgesia and blood levels of opioid drugs in patients receiving pain treatment, such as during palliative treatment. The methods of the invention comprise measuring more than one, preferably two or more surrogate markers in a patient. According to the present invention, the surrogate index correlates with the level of analgesia in subjects receiving opioids, thus providing a non-invasive method to predict and monitor analgesia during treatment. More importantly, surrogate markers are identified that correlate with blood levels of opioids in the subject. Thus, the present invention provides a valuable clinical tool to evaluate, monitor and manage pain treatment with opioids. The predictive method, a device suitable for carrying out the method of the invention and a device for medical treatment such as pain therapy are disclosed. Background technique [000...

Claims

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Application Information

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IPC IPC(8): A61B5/11A61B5/00
CPCA61B5/1106A61B3/112A61B5/1104A61B5/4821A61B5/4839A61B5/4848A61B5/0816A61B5/14542A61B5/162A61B5/7225A61B5/7275A61B5/7278
Inventor J·勒奇A·尤里齐B·厄特尔G·盖斯林格
Owner FRAUNHOFER GESELLSCHAFT ZUR FOERDERUNG DER ANGEWANDTEN FORSCHUNG EV
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