NCT01762332

Clinical Validation of Medasense Pain Response Index (PRI)

Validation of Medasense Non-invasive Nociception Monitor During Surgery and Postoperative Recovery.

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 82 (actual)
• Sponsor: Medasense Biometrics Ltd · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Detailed description

Pain is an unpleasant sensation, ranging from slight discomfort to intense suffering. Since pain is a subjective phenomenon, it has frequently defied objective, quantitative measurements. Today, in order to measure pain, subjective uni-dimensional scales are used to quantify pain. One of the most common scale used to rate a patient's pain intensity is the Numeric Pain Scale (NPS), usually scored from 0 to 100. Hitherto, those scales are based on the subjective evaluation of pain by the patient. During anesthesia the patient cannot communicate and therefore the verbal or other report is impossible. As a consequence, due to misrepresentation of the existence or extent of pain, care providers may fail to estimate the correct measure of pain and give too much or too little medication, leading to possible complications and adverse reactions. A validated scoring system of subject's pain level, or as in the case of an anaesthetised patient, subject's nociception level, is therefore needed. In this study the investigators intend to test and analyze the performances of Medasense pain response index, PRI, by comparing it with other standard pain related indicators (Heart Rate (HR), Heart Rate Variability (HRV), Skin Conductance, etc) before and after painful stimuli at different levels of analgesia. In addition, in order to reduce the variability between stimuli, a standardized stimulus (Tetanic ,30 sec, 100Hz, 60mA) will be given to all patients after sleep induction and before intubation, with and without administration of Fentanyl and the values of the PRI during these stimuli will be investigated.

Conditions

• Surgery
• Pain

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2013-01-01
• Primary completion: 2014-05-01
• Completion: 2014-05-25
• First posted: 2013-01-07
• Last updated: 2019-03-08

Locations

1 site across 1 country: Israel