Clinical Validation of Medasense Pain Response Index (PRI)
Status:
Completed
Trial end date:
2014-05-25
Target enrollment:
Participant gender:
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.