NCT04305015

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

Postoperative Benefits of Intraoperative NOL Titration - Pilot

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 26 (actual)
• Sponsor: Medasense Biometrics Ltd · Academic / Other
• Sex: All
• Age: 21 Years – 85 Years
• Healthy volunteers: Not accepted

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 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.

Conditions

• Nociceptive Pain

Interventions

Type	Name	Description
DEVICE	NOL Guided Analgesia	NOL values exceeding 25 will typically be treated with boluses of fentanyl 50 µg at roughly 5-minute intervals. The target will be maintained until surgery ends
OTHER	Routine opioid management	Clinical judgement will be according to their standard practice and may include interpretation of blood pressure, heart rate, diaphoresis, tearing, and pupil size. Boluses of fentanyl 50 µg can be given per clinical judgement

Timeline

• Start date: 2020-11-09
• Primary completion: 2020-12-30
• Completion: 2020-12-30
• First posted: 2020-03-12
• Last updated: 2021-05-06

Locations

1 site across 1 country: United States