Clinical Validation of Medasense Pain Response Index (PRI)
Summary
In our previous study, NCT01631695, we proposed and clinically evaluated the Medasense pain response index, PRI, in anesthetized patients undergoing surgery. Note: the name PRI has been changed to NoL (Nociception Level) Index. The PRI is based on a non-linear combination of several pain-related physiological parameters into a one unique index (0-100). In this study we aim to validate the performance of the PRI by: 1. investigating the patient's PRI response to surgical painful stimuli under different levels of analgesia: * Investigating patient's PRI response to surgical painful stimuli under two different levels of Remifentanil Target Control Infusion (TCI) rates. * Investigating patient's PRI response to standardized painful stimulus (Tetanic stimulus) with and without opioids. 2. investigating the effect of beta-blockers on PRI performance in patients taking chronic beta-blocker treatment. The study is based on recording and analyzing the subject's physiological signals, while recording painful events, medication dosing and different clinical signs.
Timeline
- Start
- 2013-01
- Primary completion
- 2014-05
- Completion
- 2014-05-25
Publications
- Background Treister R, Kliger M, Zuckerman G, Aryeh IG, Eisenberg E. Differentiating between heat pain intensities: the combined effect of multiple autonomic parameters. Pain. 2012 Sep;153(9):1807-1814. doi: 10.1016/j.pain.2012.04.008. Epub 2012 May 29.
- Background Ben-Israel N, Kliger M, Zuckerman G, Katz Y, Edry R. Monitoring the nociception level: a multi-parameter approach. J Clin Monit Comput. 2013 Dec;27(6):659-68. doi: 10.1007/s10877-013-9487-9. Epub 2013 Jul 9.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Remifentanil | Small molecule | 2 ng/ml | — |
| Comparator | Remifentanil | Small molecule | 4 ng/ml | — |
Indications
No indication recorded.