Pain Clinical Trial
Official title:
Validation of Medasense Non-invasive Nociception Monitor During Surgery and Postoperative Recovery.
Verified date | May 2015 |
Source | Medasense Biometrics Ltd |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 82 |
Est. completion date | May 25, 2014 |
Est. primary completion date | May 2014 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 75 Years |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
Israel | Rambam Health Care Campus | Haifa |
Lead Sponsor | Collaborator |
---|---|
Medasense Biometrics Ltd |
Israel,
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. — View Citation
Treister R, Kliger M, Zuckerman G, Goor Aryeh I, Eisenberg E. Differentiating between heat pain intensities: the combined effect of multiple autonomic parameters. Pain. 2012 Sep;153(9):1807-14. doi: 10.1016/j.pain.2012.04.008. Epub 2012 May 29. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | Change in all pain related physiological parameters (heart rate, heart rate variability, Plethysmograph amplitude, skin conductance, etc) in response to specific painful stimuli | 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) | |
Secondary | Change in Medasense index/pain related physiological parameters/subjective pain assessment in response to changes in the level of analgesic drugs | 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 |
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