Status:
COMPLETED
Performance Assessment of the PMD-200 Under General Anesthesia
Lead Sponsor:
University of Vermont
Conditions:
Pain
Opioid Use
Eligibility:
All Genders
18+ years
Brief Summary
A novel measure of nociception is the nociception level (NoL) index. The NoL index ranges from 0 to 100 and is based on a combination of nociception-related physiologic variables, which estimates the ...
Detailed Description
The primary efficacy objective of this study is to demonstrate that the NOL Index of the PMD-200 monitor (Medasense Biometrics Ltd., Ramat Gan, Israel) is correlated with the responses to noxious stim...
Eligibility Criteria
Inclusion
- Age \> 18 years old.
- Requiring laparoscopic gastrointestinal or laparoscopic hysterectomy under general anesthesia (without regional anesthesia)
- Patient provides informed consent
Exclusion
- History of severe cardiac arrhythmias within the last 12 months
- Chronic pain conditions or analgesic usage (\>1 month of large doses of opioids: more than 30mg oral equivalent of morphine)
Key Trial Info
Start Date :
March 15 2018
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
December 12 2018
Estimated Enrollment :
61 Patients enrolled
Trial Details
Trial ID
NCT03467230
Start Date
March 15 2018
End Date
December 12 2018
Last Update
April 17 2019
Active Locations (1)
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1
University of Vermont Medical Center
Burlington, Vermont, United States, 05401