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

Not Applicable

Completed

• Conditions: Nociceptive Pain
• Interventions: Other: Routine opioid management; Device: NOL Guided Analgesia

• Registration Number: NCT04305015
• Lead Sponsor: Medasense Biometrics Ltd

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-03-09
• Study First Submitted QC: 2020-03-09
• Study First Posted: 2020-03-12
• Study Start: 2020-11-09
• Primary Completion: 2020-12-30
• Study Completion: 2020-12-30
• Status Verified: 2021-04
• Last Update Submitted: 2021-05-02
• Last Update Posted: 2021-05-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 26

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Routine opioid management	Routine opioid management	Clinicians will be blinded to NOL monitoring and use clinical judgement to determine how much fentanyl should be given, and when
NOL-guided opioid administration	NOL Guided Analgesia	Clinicians will titrate fentanyl to keep NOL under 25 - always using good clinical judgement for individual patients

Primary Outcome Measures

Name	Time	Method
PACU pain score	60 minutes during recovery	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

Trial Locations

Locations (1)

Cleveland clinic; 🇺🇸 Cleveland, Ohio, United States