Status:
COMPLETED
Performance Assessment of the PMD-200 in Subjects Requiring Surgery Under General Anesthesia
Lead Sponsor:
Medasense Biometrics Ltd
Conditions:
Anesthesia
Eligibility:
All Genders
18-100 years
Brief Summary
The proposed study is designed to further demonstrate the performance of the Nociception Level (NoL) Index - in surgical patient under general anesthesia, by evaluating its response to controlled chan...
Detailed Description
The proposed study is designed to further demonstrate the performance of the NoL Index in surgical patient under general anesthesia, by evaluating its response to controlled changes in the levels of n...
Eligibility Criteria
Inclusion
- The subject age is \> 18 years old
- The subject requires surgery under general anesthesia.
- A blood pressure measurement (via arterial line or cuff) will be available during the surgical procedure.
- The subject signed an Informed Consent Form (ICF)
Exclusion
- History of severe cardiac arrhythmias within the last 12 months
- Pregnancy or lactation
- Chronic pain conditions or analgesic usage (\> 1 month of large doses of opioids: more than 30mg PO equivalent of morphine)
Key Trial Info
Start Date :
December 13 2016
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
December 1 2020
Estimated Enrollment :
80 Patients enrolled
Trial Details
Trial ID
NCT03466138
Start Date
December 13 2016
End Date
December 1 2020
Last Update
May 4 2021
Active Locations (1)
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1
Wolfson Medical Center
Holon, Israel, 5822012