Postoperative Consequences of Intraoperative NOL Titration

PHASE3CompletedINTERVENTIONAL
Enrollment

72

Participants

Timeline

Start Date

December 30, 2020

Primary Completion Date

December 30, 2022

Study Completion Date

January 10, 2023

Conditions
Anesthesia; Adverse Effect
Interventions
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

Trial Locations (1)

44195

Cleveland Clinic, Cleveland

All Listed Sponsors
lead

The Cleveland Clinic

OTHER

NCT04679818 - Postoperative Consequences of Intraoperative NOL Titration | Biotech Hunter | Biotech Hunter