NCT04679818

Postoperative Consequences of Intraoperative NOL Titration

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 72 (actual)
• Sponsor: The Cleveland Clinic · Academic / Other
• Sex: All
• Age: 21 Years – 85 Years
• Healthy volunteers: Not accepted

Summary

To demonstrate that intraoperative NOL-guided titration of fentanyl improves initial recovery characteristics.

Detailed description

Previous work has shown that NOL (Nociception Level) accurately quantifies nociception during general anesthesia.6 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 PACU (Post-Anesthesia Care Unit). 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

• Anesthesia; Adverse Effect

Interventions

Type	Name	Description
DRUG	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 1 µg/kg actual body weight (ABW), up to a maximum dose of 100 µg per bolus, can be given per clinical judgement.
DEVICE	PMD-200 Nol-guided opioid administration	PMD-200 Nociception level (NOL) values exceeding 25 for more than 30 seconds will typically be treated with boluses of fentanyl 1µg/kg ABW, up to a maximum of 100 µg per boluses, 5-minute intervals. Towards the end of the surgery (approximately 30-45 minutes before end of surgery, based on clinical judgment), the boluses of fentanyl will be reduced to 0.5 µg/kg ABW, up to a maximum of 50 µg per boluses, 5 minutes intervals. The target of a PMD-200 NOL score below 25 will be maintained until surgery ends

Timeline

• Start date: 2020-12-30
• Primary completion: 2022-12-30
• Completion: 2023-01-10
• First posted: 2020-12-22
• Last updated: 2024-06-21
• Results posted: 2024-06-21

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study