Clinical Validation of Medasense Pain Response Index (PRI)
Validation of Medasense Non-invasive Nociception Monitor During Surgery and Postoperative Recovery.
2 other identifiers
interventional
82
1 country
1
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:
- 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.
- investigating the effect of beta-blockers on PRI performance in patients taking chronic beta-blocker treatment.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable surgery
Started Jan 2013
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 23, 2012
CompletedStudy Start
First participant enrolled
January 1, 2013
CompletedFirst Posted
Study publicly available on registry
January 7, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
May 25, 2014
CompletedMarch 8, 2019
May 1, 2015
1.3 years
December 23, 2012
March 7, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change in Medasense's non-invasive pain monitoring index in response to painful events
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 Outcomes (2)
Change in all pain related physiological parameters (heart rate, heart rate variability, Plethysmograph amplitude, skin conductance, etc) in response to specific painful stimuli
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
at time of surgery. 1 minute before and 5 minute after analgesics administration
Study Arms (3)
Low opioid level
ACTIVE COMPARATORBase level of remifentanil effect side concentration: 2ng/ml Stopped recruitment (May 2014)
High opioid level
ACTIVE COMPARATORBase level of remifentanil effect side concentration: 4ng/ml Stopped recruitment (May 2014)
chronic beta-blocker treatment
OTHERPatients with chronic beta-blocker treatment prior to surgery and study. Will all be allocated to the high opioid level arm without randomization. Continue recruitment.
Interventions
constant remifentanil level of 2ng/ml administered using Target Control Infusion pumps.
constant remifentanil level of 4ng/ml administered using Target Control Infusion pumps.
Patients from the chronic beta-blocker treatment group will not be randomized, and will all be allocated to the high opioid level group.
Eligibility Criteria
You may qualify if:
- ASA physical status 1-3
- Elective surgery
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Rambam Health Care Campus
Haifa, 31096, Israel
Related Publications (2)
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.
PMID: 22647429BACKGROUNDBen-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.
PMID: 23835792BACKGROUND
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Ruth Edry, MD
Rambam Health Care Campus
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR
- Purpose
- SCREENING
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 23, 2012
First Posted
January 7, 2013
Study Start
January 1, 2013
Primary Completion
May 1, 2014
Study Completion
May 25, 2014
Last Updated
March 8, 2019
Record last verified: 2015-05