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Clinical Validation of Medasense Pain Response Index (PRI)

NCT01762332 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 82

Last updated 2019-03-08

No results posted yet for this study

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.

Conditions

Interventions

DRUG

Base level of remifentanil effect side concentration: 2ng/ml

constant remifentanil level of 2ng/ml administered using Target Control Infusion pumps.

DRUG

Base level of remifentanil effect side concentration: 4ng/ml

constant remifentanil level of 4ng/ml administered using Target Control Infusion pumps.

OTHER

chronic beta-blocker treatment

Patients from the chronic beta-blocker treatment group will not be randomized, and will all be allocated to the high opioid level group.

Sponsors & Collaborators

  • Medasense Biometrics Ltd

    lead OTHER

Principal Investigators

  • Ruth Edry, MD · Rambam Health Care Campus

Study Design

Allocation
RANDOMIZED
Purpose
SCREENING
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-01-31
Primary Completion
2014-05-31
Completion
2014-05-25

Countries

  • Israel

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01762332 on ClinicalTrials.gov