Clinical trial NCT04679818: Postoperative Consequences of Intraoperative NOL Titration
Official title: Postoperative Consequences of Intraoperative NOL Titration
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Anesthesia; Adverse Effect
Lead sponsor: The Cleveland Clinic
Sponsor class: OTHER
First posted: 2020-12-22
Enrollment: 72
Sex: ALL
Minimum age (years): 21
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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

Detailed description: Previous work has shown that NOL (Nociception Level) 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 (Post-Anesthesia Care Unit). 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.

Eligibility criteria: 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

Primary outcomes:
measure: Pain Scores at 10-minute Intervals for the Initial Hour of Recovery
timeFrame: At 10-minute intervals during the first 60 minutes after extubation.
measure: Pain Scores at 10-minute Intervals for the Initial 30 Minutes of Recovery
timeFrame: At 10-minute intervals during the first 30 minutes after extubation.
Secondary outcomes:
measure: Number of Measurements With Pain Score Less Than 5 (vs ≥5) for Initial Hour of Recovery
timeFrame: At 10-minute intervals during the first 60 minutes after extubation.
measure: Number of Measurements With Pain Score Less Than 5 (vs ≥5) for the Initial 30 Minutes of Recovery
timeFrame: At 10-minute intervals during the first 30 minutes after extubation.
Other outcomes:
measure: Number of Analgesic Rescue Boluses
timeFrame: During the first 60 minutes after extubation.
measure: Ramsay Scores During the First 60 Minutes
timeFrame: At 10-minute intervals during the first 60 minutes after extubation.
measure: Treatment Effect on the Time to Emergence From Anesthesia.
timeFrame: From discontinuation of sevoflurane anesthesia to extubation intraoperatively, assessed up to the timepoint of leaving operation room.
Locations:
city: Cleveland
country: United States
facility: Cleveland Clinic
state: Ohio
Study officials:
affiliation: The Cleveland Clinic
name: Kurt Ruetzler, MD
role: PRINCIPAL_INVESTIGATOR
References: