Postoperative Consequences of Intraoperative NOL Titration

NeuroTherapia, Inc.

Status and phase: Completed; Phase 3

Conditions: Anesthesia; Adverse Effect

Treatments: Drug: Routine opioid management; Device: PMD-200 Nol-guided opioid administration

Study type: Interventional

Funder types: Other

Identifiers

NCT04679818

19-1646

Details and patient eligibility

About

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

Full 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.

Enrollment: 72 patients

Sex: All

Ages: 21 to 85 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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72 participants in 2 patient groups

PMD-200 NOL group

Active Comparator group

Description:

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

Treatment:

Device: PMD-200 Nol-guided opioid administration

Control Group

Active Comparator group

Description:

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.

Treatment:

Drug: Routine opioid management