Postoperative Consequences of Intraoperative NOL Titration

NCT ID: NCT04679818

Last Updated: 2024-06-21

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 72 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-12-30
• Study Completion Date: 2023-01-10

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.

Conditions

Anesthesia; Adverse Effect

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: DOUBLE

Study Groups

PMD-200 NOL group

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

Group Type: ACTIVE_COMPARATOR

PMD-200 Nol-guided opioid administration

Intervention Type: 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

Control Group

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.

Group Type: ACTIVE_COMPARATOR

Routine opioid management

Intervention Type: 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.

Interventions

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.

Intervention Type: DRUG

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

Intervention Type: DEVICE

Other Intervention Names

Fentanyl; PMD-200 NOL

Eligibility Criteria

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

• Minimum Eligible Age: 21 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

The Cleveland Clinic

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Kurt Ruetzler, MD

Role: PRINCIPAL_INVESTIGATOR

The Cleveland Clinic

Locations

Cleveland Clinic

Cleveland, Ohio, United States

Countries

United States

References

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.

Reference Type: DERIVED

PMID: 36727855 (View on PubMed)

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

19-1646

Identifier Type: -

Identifier Source: org_study_id