Clinical Validation of Medasense Pain Response Index (PRI)

March 7, 2019 updated by: Medasense Biometrics Ltd

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

82

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Israel
      • Haifa, Israel, 31096
        • Rambam Health Care Campus

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: SCREENING
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: TRIPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Low opioid level
Base level of remifentanil effect side concentration: 2ng/ml Stopped recruitment (May 2014)
Drug: Base level of remifentanil effect side concentration: 2ng/ml
constant remifentanil level of 2ng/ml administered using Target Control Infusion pumps.
Other Names:
  • Ultiva
Active Comparator: High opioid level
Base level of remifentanil effect side concentration: 4ng/ml Stopped recruitment (May 2014)
Drug: Base level of remifentanil effect side concentration: 4ng/ml
constant remifentanil level of 4ng/ml administered using Target Control Infusion pumps.
Other Names:
  • Ultiva
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.
Other: chronic beta-blocker treatment

Patients with chronic beta-blocker treatment prior to surgery and study. Will all be allocated to the high opioid level arm without randomization.

Continue recruitment.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Medasense's non-invasive pain monitoring index in response to painful events
Time Frame: at time of surgery. 1 minute before and 1 minute after painful stimuli (for instance: intubation, skin incision, trocar insertion)

outcome measure will be assessed one minute before painful event, and will be compared to a measure taken during the painful event.

Note: during data analysis it became aparent that these definitions cannot be met. For example: the time of various clinical stimuli cannot be identified within seconds. Also, there is no meaning to a measure taken during event. Therefore, to avoid including part of the stimulus in the pre stimulus window, we restricted analysis to the first 30 seconds of the designated 1 minute before the event (-30 to -60 seconds). Similarly, the post stimulus window start was defined 10 seconds after the event annotation and the post stimulus window enlarged to 80 seconds.
at time of surgery. 1 minute before and 1 minute after painful stimuli (for instance: intubation, skin incision, trocar insertion)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in all pain related physiological parameters (heart rate, heart rate variability, Plethysmograph amplitude, skin conductance, etc) in response to specific painful stimuli
Time Frame: at time of surgery. 1 minute before and 1 minute after painful stimuli (for instance: intubation, skin incision, trocar insertion)

Outcome measures will be assessed one minute before painful event, and will be compared to measures taken during the painful event.

Note: same changes as in outcome 1 measure.
at time of surgery. 1 minute before and 1 minute after painful stimuli (for instance: intubation, skin incision, trocar insertion)
Change in Medasense index/pain related physiological parameters/subjective pain assessment in response to changes in the level of analgesic drugs
Time Frame: at time of surgery. 1 minute before and 5 minute after analgesics administration

Outcome measures will be assessed one minute before administration of analgesic drug, and will be compared to measures taken 5 minutes after.

Note: after fentanyl administration - same change as in outcome 1 measure.
at time of surgery. 1 minute before and 5 minute after analgesics administration

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Medasense Biometrics Ltd

Investigators

  • Principal Investigator: Ruth Edry, MD, Rambam Health Care Campus

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2013

Primary Completion (Actual)

May 1, 2014

Study Completion (Actual)

May 25, 2014

Study Registration Dates

First Submitted

December 23, 2012

First Submitted That Met QC Criteria

January 4, 2013

First Posted (Estimate)

January 7, 2013

Study Record Updates

Last Update Posted (Actual)

March 8, 2019

Last Update Submitted That Met QC Criteria

March 7, 2019

Last Verified

May 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Medasense003
  • 0326-12-RMB (Other Identifier: Rambam Health Care Campus, Haifa, Israel)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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