Status:
COMPLETED
Postoperative Benefits of Intraoperative Nociception Level (NOL) Titration - Pilot
Lead Sponsor:
Medasense Biometrics Ltd
Conditions:
Nociceptive Pain
Eligibility:
All Genders
21-85 years
Phase:
NA
Brief Summary
Previous work has shown that NOL (Medasense, Ramat Gan, Israel) accurately quantifies nociception during general anesthesia. Presumably, titrating opioids to NOL will therefore provide individual guid...
Eligibility Criteria
Inclusion
- Adults having major non-cardiac surgery expected to last ≥2 hours;
- American Society of Anesthesiologists physical status 1-3;
- Age 21-85 years old;
- Planned endotracheal intubation
Exclusion
- Planned neuraxial or regional block;
- Local anesthetic infiltration at surgical field;
- Clinician preference for an opioid other than, or in addition to, fentanyl;
- Non-sinus heart rhythm;
- Neurologic condition that, in the opinion of the investigators, may preclude accurate assessment of postoperative pain and nausea;
- Lack of English language fluency;
- Routine user of psychoactive drugs other than opioids;
- Contraindication to sevoflurane, fentanyl, morphine, or ondansetron.
- Intracranial surgery
- BMI \> 40
Key Trial Info
Start Date :
November 9 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 30 2020
Estimated Enrollment :
26 Patients enrolled
Trial Details
Trial ID
NCT04305015
Start Date
November 9 2020
End Date
December 30 2020
Last Update
May 6 2021
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Cleveland clinic
Cleveland, Ohio, United States, 44195