Intraoperative NOL Titration

Study Overview
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Brief Summary
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To demonstrate that intraoperative NOL-guided titration of fentanyl improves initial recovery characteristics.

Detailed Description
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Previous work has shown that NOL 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. 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 Consequences of Intraoperative NOL Titration

Conditions
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Anesthesia; Adverse Effect

Intervention / Treatment
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* Drug: Routine opioid management
* Device: PMD-200 Nol-guided opioid administration


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 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

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: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Control Group<br>Clinicians will be blinded to PMD-200 NOL monitoring and use clinical judgement to determine how much fentanyl should be given, and when. | Device: PMD-200 Nol-guided opioid administration<br>* PMD-200 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<br>* Other names: PMD-200 NOL;|
| Active Comparator: PMD-200 NOL group<br>Clinicians will titrate fentanyl to keep PMD-200 NOL under 25 - always using good clinical judgement for individual patients | Drug: 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 1 µg/kg actual body weight (ABW), up to a maximum dose of 100 µg per bolus, can be given per clinical judgement.<br>* Other names: Fentanyl;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain Scores | The investigators will evaluate the pain scores at 10-minute using pain scores (0-10 verbal response scale) | 60 minutes | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain Scores <5. | The investigators will evaluate whether or not the pain score at any measured interval is < 5, using (0-10 verbal response scale) | 60 minutes |