Postoperative Benefits of Intraoperative Nociception Level (NOL) Titration

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

26 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-11-09

Study Completion Date

2020-12-30

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.

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Detailed Description

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Conditions

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Nociceptive Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

NOL-Guided analgesia vs. Routine Management

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Anesthesia clinicians cannot be blinded since they will need to titrate opioid administration to NOL. However, all postoperative care and evaluations will be fully blinded to randomization, thus preventing measurement bias

Study Groups

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Routine opioid management

Clinicians will be blinded to 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 OTHER

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

NOL-guided opioid administration

Clinicians will titrate fentanyl to keep NOL under 25 - always using good clinical judgement for individual patients

Group Type EXPERIMENTAL

NOL Guided Analgesia

Intervention Type DEVICE

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

Interventions

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NOL Guided Analgesia

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

Intervention Type DEVICE

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 50 µg can be given per clinical judgement

Intervention Type OTHER

Other Intervention Names

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Physiological Monitoring Device: PMD-200 system

Eligibility Criteria

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Inclusion Criteria

1. Adults having major non-cardiac surgery expected to last ≥2 hours;
2. American Society of Anesthesiologists physical status 1-3;
3. Age 21-85 years old;
4. Planned endotracheal intubation

Exclusion Criteria

1. Planned neuraxial or regional block;
2. Local anesthetic infiltration at surgical field;
3. Clinician preference for an opioid other than, or in addition to, fentanyl;
4. Non-sinus heart rhythm;
5. Neurologic condition that, in the opinion of the investigators, may preclude accurate assessment of postoperative pain and nausea;
6. Lack of English language fluency;
7. Routine user of psychoactive drugs other than opioids;
8. Contraindication to sevoflurane, fentanyl, morphine, or ondansetron.
9. Intracranial surgery
10. BMI \> 40

Minimum Eligible Age

21 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No