Clinical trial NCT01762332: Clinical Validation of Medasense Pain Response Index (PRI)
Official title: Validation of Medasense Non-invasive Nociception Monitor During Surgery and Postoperative Recovery.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Surgery
Pain
Keywords: nociception
analgesia
intraoperative monitoring
Lead sponsor: Medasense Biometrics Ltd
Sponsor class: OTHER
First posted: 2013-01-07
Enrollment: 82
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SCREENING

Brief 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.

Eligibility 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

Primary outcomes:
measure: Change in Medasense's non-invasive pain monitoring index in response to painful events
timeFrame: at time of surgery. 1 minute before and 1 minute after painful stimuli (for instance: intubation, skin incision, trocar insertion)
Secondary outcomes:
measure: Change in all pain related physiological parameters (heart rate, heart rate variability, Plethysmograph amplitude, skin conductance, etc) in response to specific painful stimuli
timeFrame: at time of surgery. 1 minute before and 1 minute after painful stimuli (for instance: intubation, skin incision, trocar insertion)
measure: Change in Medasense index/pain related physiological parameters/subjective pain assessment in response to changes in the level of analgesic drugs
timeFrame: at time of surgery. 1 minute before and 5 minute after analgesics administration
Other outcomes:
Locations:
city: Haifa
country: Israel
facility: Rambam Health Care Campus
Study officials:
affiliation: Rambam Health Care Campus
name: Ruth Edry, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Treister R, Kliger M, Zuckerman G, Aryeh IG, Eisenberg E. Differentiating between heat pain intensities: the combined effect of multiple autonomic parameters. Pain. 2012 Sep;153(9):1807-1814. doi: 10.1016/j.pain.2012.04.008. Epub 2012 May 29.
citation: Ben-Israel N, Kliger M, Zuckerman G, Katz Y, Edry R. Monitoring the nociception level: a multi-parameter approach. J Clin Monit Comput. 2013 Dec;27(6):659-68. doi: 10.1007/s10877-013-9487-9. Epub 2013 Jul 9.