Postoperative Benefits of Intraoperative Nociception Level (NOL) Titration - Pilot

Completed · Not applicable

Conditions studied: Nociceptive Pain

In brief

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 guidance so that patients will be given about the right amount. Patient given the right amount will presumably awaken quickly when anesthesia is done, and have good initial pain control in the post anesthesia care unit (PACU). To the extent that NOL titration facilitates optimal opioid dosing, patients are likely to have better PACU experiences - which would be an important outcome that clinicians and regulators are likely to take seriously.

Key facts

Study ID

NCT04305015

Run by

Medasense Biometrics Ltd

People needed

26

Starts

2020-11-09

Expected to finish

2020-12-30

Last updated by the study team

2021-05-06

Who can join

Age: 21 and older, up to 85. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Cleveland clinic — Cleveland, Ohio, United States

Full record on ClinicalTrials.gov

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