Overview

Clinical Validation of Medasense Pain Response Index (PRI)

Status:
Completed

Trial end date:
2014-05-25

Target enrollment:
0

Participant gender:
All

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.

Phase:

N/A

Accepts Healthy Volunteers?

Details

Lead Sponsor:

Medasense Biometrics Ltd

Treatments:

Adrenergic beta-Antagonists
Analgesics, Opioid
Remifentanil

Criteria

Inclusion Criteria:

- ASA physical status 1-3

- Elective surgery

Exclusion Criteria:

- Pregnancy or lactation

- History of severe cardiac arrhythmias

- Abuse of alcohol or illicit drugs

- History of mental retardation, dementia, psychiatric disorders

- Allergy to any of the drugs to be used during anesthesia and recovery