Postoperative Benefits of Intraoperative Nociception Level (NOL) Titration - Pilot

Study Overview
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Brief Summary
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Previous work has shown that NOL (Medasense, Ramat Gan, Israel) accurately quantifies nociception during general anesthesia. 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 post anesthesia care unit (PACU). 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.

Official Title
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Postoperative Benefits of Intraoperative NOL Titration - Pilot

Conditions
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Nociceptive Pain

Intervention / Treatment
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* Device: NOL Guided Analgesia
* Other: Routine opioid management


Participation Criteria
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Eligibility Criteria
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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; Local anesthetic infiltration at surgical field; Clinician preference for an opioid other than, or in addition to, fentanyl; Non-sinus heart rhythm; 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

Ages Eligible for Study
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Minimum Age: 21 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: NOL-Guided analgesia vs. Routine Management
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Routine opioid management<br>Clinicians will be blinded to NOL monitoring and use clinical judgement to determine how much fentanyl should be given, and when | Other: Routine opioid management<br>* 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 50 µg can be given per clinical judgement<br>|
| Experimental: NOL-guided opioid administration<br>Clinicians will titrate fentanyl to keep NOL under 25 - always using good clinical judgement for individual patients | Device: NOL Guided Analgesia<br>* NOL values exceeding 25 will typically be treated with boluses of fentanyl 50 µg at roughly 5-minute intervals. The target will be maintained until surgery ends<br>* Other names: Physiological Monitoring Device: PMD-200 system;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| PACU pain score | Average pain scores (0-10 verbal response scale) at 10-minute intervals during the initial 60 minutes of recovery are more often between 1 and 3 or significantly lower with NOL-guided fentanyl than with routine care | 60 minutes during recovery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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NOL, Nociception