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

NCT04305015 | Completed

• 1 other identifier: CLI-20-01
• Study Type: interventional
• Target: 26
• Locations: 1 country
• Sites: 1

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.

Conditions

Nociceptive Pain

Keywords

NOL; Nociception

Outcome Measures

Primary Outcomes (1)

• PACU pain score

  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

  60 minutes during recovery

Study Arms (2)

Routine opioid management

ACTIVE COMPARATOR

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

Other: Routine opioid management

NOL-guided opioid administration

EXPERIMENTAL

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

Device: NOL Guided Analgesia

Interventions

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

Also known as: Physiological Monitoring Device: PMD-200 system

NOL-guided opioid administration

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

Routine opioid management

Eligibility Criteria

• Age: 21 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Medasense Biometrics Ltd: lead

Study Sites (1)

Cleveland clinic

Cleveland, Ohio, 44195, United States

Location

MeSH Terms

Conditions

Nociceptive Pain

Condition Hierarchy (Ancestors)

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: 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
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: NOL-Guided analgesia vs. Routine Management

Study Record Dates

• First Submitted: March 9, 2020
• First Posted: March 12, 2020
• Study Start: November 9, 2020
• Primary Completion: December 30, 2020
• Study Completion: December 30, 2020
• Last Updated: May 6, 2021

Record last verified: 2021-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)