Clinical Validation of Medasense Pain Response Index (PRI)
NCT ID: NCT01762332
Last Updated: 2019-03-08
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
82 participants
INTERVENTIONAL
2013-01-31
2014-05-25
Brief Summary
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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.
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Detailed Description
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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
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Study Design
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RANDOMIZED
PARALLEL
SCREENING
TRIPLE
Study Groups
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Low opioid level
Base level of remifentanil effect side concentration: 2ng/ml Stopped recruitment (May 2014)
Base level of remifentanil effect side concentration: 2ng/ml
constant remifentanil level of 2ng/ml administered using Target Control Infusion pumps.
High opioid level
Base level of remifentanil effect side concentration: 4ng/ml Stopped recruitment (May 2014)
Base level of remifentanil effect side concentration: 4ng/ml
constant remifentanil level of 4ng/ml administered using Target Control Infusion pumps.
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.
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.
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.
Interventions
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Base level of remifentanil effect side concentration: 2ng/ml
constant remifentanil level of 2ng/ml administered using Target Control Infusion pumps.
Base level of remifentanil effect side concentration: 4ng/ml
constant remifentanil level of 4ng/ml administered using Target Control Infusion pumps.
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 Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Elective surgery
Exclusion Criteria
* 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
18 Years
75 Years
ALL
No
Sponsors
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Medasense Biometrics Ltd
OTHER
Responsible Party
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Principal Investigators
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Ruth Edry, MD
Role: PRINCIPAL_INVESTIGATOR
Rambam Health Care Campus
Locations
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Rambam Health Care Campus
Haifa, , Israel
Countries
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References
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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.
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.
Other Identifiers
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0326-12-RMB
Identifier Type: OTHER
Identifier Source: secondary_id
Medasense003
Identifier Type: -
Identifier Source: org_study_id
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