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

Medasense

Status: Completed

Conditions: Nociceptive Pain

Treatments: Other: Routine opioid management; Device: NOL Guided Analgesia

Study type: Interventional

Funder types: Other

Identifiers

NCT04305015

CLI-20-01

Details and patient eligibility

About

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.

Enrollment: 26 patients

Sex: All

Ages: 21 to 85 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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26 participants in 2 patient groups

Routine opioid management

Active Comparator group

Description:

Clinicians will be blinded to NOL monitoring and use clinical judgement to determine how much fentanyl should be given, and when

Treatment:

Other: Routine opioid management

NOL-guided opioid administration

Experimental group

Description:

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

Treatment:

Device: NOL Guided Analgesia