Postoperative Consequences of Intraoperative NOL Titration

Phase 3

Completed

• Conditions: Anesthesia; Adverse Effect
• Interventions: Device: PMD-200 Nol-guided opioid administration; Drug: Routine opioid management

• Registration Number: NCT04679818
• Lead Sponsor: The Cleveland Clinic

Brief 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.

Study Timeline

• Study First Submitted: 2020-12-17
• Study First Submitted QC: 2020-12-17
• Study First Posted: 2020-12-22
• Study Start: 2020-12-30
• Primary Completion: 2022-12-30
• Study Completion: 2023-01-10
• Results First Submitted: 2024-03-01
• Status Verified: 2024-05
• Results First Submitted QC: 2024-06-18
• Last Update Submitted: 2024-06-18
• Results First Posted: 2024-06-21
• Last Update Posted: 2024-06-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 72

Inclusion Criteria

• 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

Exclusion Criteria

• Planned neuraxial or regional block
• Clinician preference for an opioid other than, or in addition to, fentanyl
• Non-sinus heart
• 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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
PMD-200 NOL group	PMD-200 Nol-guided opioid administration	Clinicians will titrate fentanyl to keep PMD-200 (Pain Monitoring Device) Nociception level (NOL) under 25 - always using good clinical judgement for individual patients
Control Group	Routine opioid management	Clinicians will be blinded to PMD-200 Nociception level (NOL) monitoring and use clinical judgement to determine how much fentanyl should be given, and when.

Primary Outcome Measures

Name	Time	Method
Pain Scores at 10-minute Intervals for the Initial 30 Minutes of Recovery	At 10-minute intervals during the first 30 minutes after extubation.	Pain scores are measured using a Verbal Response Scale (VRS) at 10-minute intervals for the initial 30 minutes of recovery. VRS is a scale from 0 to 10 where 0 signifies no pain and 10 signifies the worst pain ever experienced.
Pain Scores at 10-minute Intervals for the Initial Hour of Recovery	At 10-minute intervals during the first 60 minutes after extubation.	Pain scores are measured using a Verbal Response Scale (VRS) every 10 minutes in the initial hour of recovery. VRS is a scale from 0 to 10 where 0 signifies no pain and 10 signifies the worst pain ever experienced.

Secondary Outcome Measures

Name	Time	Method
Number of Measurements With Pain Score Less Than 5 (vs ≥5) for the Initial 30 Minutes of Recovery	At 10-minute intervals during the first 30 minutes after extubation.	Binary repeated-measures outcome will be defined as a pain score less than 5 (vs ≥5). Pain scores will be measured using a Verbal Response Scale (VRS) at 10-minute intervals for the 30 minutes of recovery. VRS is a scale from 0 to 10 where 0 signifies no pain and 10 signifies the worst pain ever experienced.
Number of Measurements With Pain Score Less Than 5 (vs ≥5) for Initial Hour of Recovery	At 10-minute intervals during the first 60 minutes after extubation.	Binary repeated-measures outcome of pain score will be defined as a pain score less than 5 (vs ≥5). Pain scores will be measured using a Verbal Response Scale (VRS) at 10-minute intervals for the initial hour of recovery. VRS is a scale from 0 to 10 where 0 signifies no pain and 10 signifies the worst pain ever experienced.

Trial Locations

Locations (1)

Cleveland Clinic; 🇺🇸 Cleveland, Ohio, United States