Postoperative Consequences of Intraoperative NOL Titration

Anesthesia; Adverse Effect Clinical Trial

Official title:

Postoperative Consequences of Intraoperative NOL Titration

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04679818
• Other study ID #: 19-1646
• Status: Completed
• Phase: Phase 3
• Start date: December 30, 2020
• Est. completion date: January 10, 2023

Study information

• Verified date: January 2024
• Source: The Cleveland Clinic
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

To demonstrate that intraoperative NOL-guided titration of fentanyl improves initial recovery characteristics.

Description:

Previous work has shown that NOL accurately quantifies nociception during general anesthesia.6 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 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 73
• Est. completion date: January 10, 2023
• Est. primary completion date: December 30, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years to 85 Years

Eligibility

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
• Clinician preference for an opioid other than, or in addition to, fentanyl
• Non-sinus heart
• 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

Related Conditions & MeSH terms

• Anesthesia; Adverse Effect

Intervention

Drug:
• 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 1 µg/kg actual body weight (ABW), up to a maximum dose of 100 µg per bolus, can be given per clinical judgement.

Device:
• PMD-200 Nol-guided opioid administration
PMD-200 NOL values exceeding 25 for more than 30 seconds will typically be treated with boluses of fentanyl 1µg/kg ABW, up to a maximum of 100 µg per boluses, 5-minute intervals. Towards the end of the surgery (approximately 30-45 minutes before end of surgery, based on clinical judgment), the boluses of fentanyl will be reduced to 0.5 µg/kg ABW, up to a maximum of 50 µg per boluses, 5 minutes intervals. The target of a PMD-200 NOL score below 25 will be maintained until surgery ends

Locations

Country	Name	City	State
United States	Cleveland Clinic	Cleveland	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
The Cleveland Clinic

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pain Scores	The investigators will evaluate the pain scores at 10-minute using pain scores (0-10 verbal response scale)	60 minutes
Secondary	Pain Scores <5.	The investigators will evaluate whether or not the pain score at any measured interval is < 5, using (0-10 verbal response scale)	60 minutes