At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Postoperative Consequences of Intraoperative NOL Titration
In Brief
A Phase 3 clinical trial evaluating Routine opioid management and PMD-200 Nol-guided opioid administration for Anesthesia; Adverse Effect. Completed, enrolled 72 participants across 1 site.
Detailed Summary
To demonstrate that intraoperative NOL-guided titration of fentanyl improves initial recovery characteristics.
Study Details
Timeline
Interventions
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.
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