Postoperative Consequences of Intraoperative NOL Titration

NCT04679818 | Completed Phase 3 Results FDA Device

• 1 other identifier: 19-1646
• Study Type: interventional
• Target: 72
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Anesthesia; Adverse Effect

Outcome Measures

Primary Outcomes (2)

• Pain Scores at 10-minute Intervals for the Initial Hour of Recovery

  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.

  At 10-minute intervals during the first 60 minutes after extubation.

• Pain Scores at 10-minute Intervals for the Initial 30 Minutes of Recovery

  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.

  At 10-minute intervals during the first 30 minutes after extubation.

Secondary Outcomes (2)

• 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.

• 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.

Other Outcomes (3)

• Number of Analgesic Rescue Boluses

  During the first 60 minutes after extubation.

• Ramsay Scores During the First 60 Minutes

  At 10-minute intervals during the first 60 minutes after extubation.

• Treatment Effect on the Time to Emergence From Anesthesia.

  From discontinuation of sevoflurane anesthesia to extubation intraoperatively, assessed up to the timepoint of leaving operation room.

Study Arms (2)

PMD-200 NOL group

ACTIVE COMPARATOR

Clinicians will titrate fentanyl to keep PMD-200 (Pain Monitoring Device) Nociception level (NOL) under 25 - always using good clinical judgement for individual patients

Device: PMD-200 Nol-guided opioid administration

Control Group

ACTIVE COMPARATOR

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.

Drug: Routine opioid management

Interventions

Routine opioid management DRUG

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.

Also known as: Fentanyl

Control Group

PMD-200 Nol-guided opioid administration DEVICE

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

Also known as: PMD-200 NOL

PMD-200 NOL group

Eligibility Criteria

• Age: 21 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• The Cleveland Clinic: lead

Study Sites (1)

Cleveland Clinic

Cleveland, Ohio, 44195, United States

Location

Related Publications (1)

• Ruetzler K, Montalvo M, Bakal O, Essber H, Rossler J, Mascha EJ, Han Y, Ramachandran M, Keebler A, Turan A, Sessler DI. Nociception Level Index-Guided Intraoperative Analgesia for Improved Postoperative Recovery: A Randomized Trial. Anesth Analg. 2023 Apr 1;136(4):761-771. doi: 10.1213/ANE.0000000000006351. Epub 2023 Jan 20.

  PMID: 36727855 DERIVED

MeSH Terms

Interventions

Fentanyl

Intervention Hierarchy (Ancestors)

Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Results Point of Contact

• Title: Kurt Ruetzler
• Organization: Cleveland Clinic

ruetzlk@ccf.org

216 636-0561

Study Officials

• Kurt Ruetzler, MD

  The Cleveland Clinic

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 17, 2020
• First Posted: December 22, 2020
• Study Start: December 30, 2020
• Primary Completion: December 30, 2022
• Study Completion: January 10, 2023
• Last Updated: June 21, 2024
• Results First Posted: June 21, 2024

Record last verified: 2024-05

Locations

US (1)