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

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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Key information

Conditions

Nociceptive Pain Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

21 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Cleveland clinic

Cleveland, Ohio, 44195, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

NOL Guided Analgesia

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

Other names: Physiological Monitoring Device: PMD-200 system

Routine opioid management

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

Primary outcomes

PACU pain score

Time frame: 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

Sponsors and collaborators

Lead sponsor

Medasense Biometrics Ltd

Other

Registry information

Official study title

Postoperative Benefits of Intraoperative NOL Titration - Pilot

Important dates

Study start: 2020
Primary completion: 2020
Study completion: 2020
First posted: Mar 12, 2020
Registry last updated: May 6, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed