Clinical Validation of Medasense Pain Response Index (PRI)

This study is currently recruiting participants. (see Contacts and Locations)
Verified September 2013 by Medasense Biometrics Ltd
Sponsor:
Information provided by (Responsible Party):
Medasense Biometrics Ltd
ClinicalTrials.gov Identifier:
NCT01762332
First received: December 23, 2012
Last updated: September 1, 2013
Last verified: September 2013
  Purpose

In our previous study, NCT01631695, we proposed and clinically evaluated the Medasense pain response index, PRI, in anesthetized patients undergoing surgery.

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.


Condition Intervention
Surgery
Pain
Drug: Base level of remifentanil effect side concentration: 2ng/ml
Drug: Base level of remifentanil effect side concentration: 4ng/ml

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Investigator, Outcomes Assessor)
Primary Purpose: Screening
Official Title: Validation of Medasense Non-invasive Nociception Monitor During Surgery and Postoperative Recovery.

Resource links provided by NLM:


Further study details as provided by Medasense Biometrics Ltd:

Primary Outcome Measures:
  • 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) ] [ Designated as safety issue: No ]
    outcome measure will be assessed one minute before painful event, and will be compared to a measure taken during the painful event.


Secondary Outcome Measures:
  • 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) ] [ Designated as safety issue: No ]
    Outcome measures will be assessed one minute before painful event, and will be compared to measures taken during the painful event.

  • 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 ] [ Designated as safety issue: No ]
    Outcome measures will be assessed one minute before administration of analgesic drug, and will be compared to measures taken 5 minutes after.


Estimated Enrollment: 100
Study Start Date: January 2013
Estimated Study Completion Date: January 2014
Estimated Primary Completion Date: January 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Low opioid level
Base level of remifentanil effect side concentration: 2ng/ml
Drug: Base level of remifentanil effect side concentration: 2ng/ml
constant remifentanil level of 2ng/ml administrated using Target Control Infusion pumps.
Other Name: Ultiva
Active Comparator: High opioid level
Base level of remifentanil effect side concentration: 4ng/ml
Drug: Base level of remifentanil effect side concentration: 4ng/ml
constant remifentanil level of 4ng/ml administrated using Target Control Infusion pumps.
Other Name: Ultiva

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.

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01762332

Contacts
Contact: Ruth Edry, MD +972-4-8542487 r_edery@rambam.health.gov.il

Locations
Israel
Rambam Health Care Campus Recruiting
Haifa, Israel, 31096
Contact: Ruth Edry, MD       r_edery@rambam.health.gov.il   
Principal Investigator: Ruth Edry, MD         
Sponsors and Collaborators
Medasense Biometrics Ltd
Investigators
Principal Investigator: Ruth Edry, MD Rambam Health Care Campus
  More Information

Publications:
Responsible Party: Medasense Biometrics Ltd
ClinicalTrials.gov Identifier: NCT01762332     History of Changes
Other Study ID Numbers: Medasense003, 0326-12-RMB
Study First Received: December 23, 2012
Last Updated: September 1, 2013
Health Authority: Israel: Ministry of Health

Additional relevant MeSH terms:
Remifentanil
Analgesics, Opioid
Narcotics
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Therapeutic Uses
Hypnotics and Sedatives
Anesthetics, Intravenous
Anesthetics, General
Anesthetics

ClinicalTrials.gov processed this record on August 01, 2014