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: May 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 (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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 72
• 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 Nociception level (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
Other	Number of Analgesic Rescue Boluses	Number of analgesic rescue boluses in the first 60 minutes after extubation.	During the first 60 minutes after extubation.
Other	Ramsay Scores During the First 60 Minutes	Ramsay scores will be measured using Ramsay Sedation Scale every 10 minutes in the initial hour of recovery. Ramsay Sedation Scale: 1 = Patient is anxious and agitated or restless, or both; 2 = Patient is co-operative, oriented, and tranquil; 3 = Patient responds to commands only; 4 = Patient exhibits brisk response to light glabellar tap or loud auditory stimulus; 5 = Patient exhibits a sluggish response to light glabellar tap or loud auditory stimulus; 6 = Patient exhibits no response. Frequencies for each score were reported.	At 10-minute intervals during the first 60 minutes after extubation.
Other	Treatment Effect on the Time to Emergence From Anesthesia.	Time to emergence from anesthesia is defined as minutes from discontinuation of sevoflurane anesthesia to extubation	From discontinuation of sevoflurane anesthesia to extubation intraoperatively, assessed up to the timepoint of leaving operation room.
Primary	Pain Scores at 10-minute Intervals for the Initial Hour of Recovery	Pain scores are measured using a Verbal Response Scale (VRS) every 10 minutes in the initial hour of recovery. VRS is a scale from 0 to 10 where 0 signifies no pain and 10 signifies the worst pain ever experienced.	At 10-minute intervals during the first 60 minutes after extubation.
Primary	Pain Scores at 10-minute Intervals for the Initial 30 Minutes of Recovery	Pain scores are measured using a Verbal Response Scale (VRS) at 10-minute intervals for the initial 30 minutes of recovery. VRS is a scale from 0 to 10 where 0 signifies no pain and 10 signifies the worst pain ever experienced.	At 10-minute intervals during the first 30 minutes after extubation.
Secondary	Number of Measurements With Pain Score Less Than 5 (vs =5) for Initial Hour of Recovery	Binary repeated-measures outcome of pain score will be defined as a pain score less than 5 (vs =5). Pain scores will be measured using a Verbal Response Scale (VRS) at 10-minute intervals for the initial hour of recovery. VRS is a scale from 0 to 10 where 0 signifies no pain and 10 signifies the worst pain ever experienced.	At 10-minute intervals during the first 60 minutes after extubation.
Secondary	Number of Measurements With Pain Score Less Than 5 (vs =5) for the Initial 30 Minutes of Recovery	Binary repeated-measures outcome will be defined as a pain score less than 5 (vs =5). Pain scores will be measured using a Verbal Response Scale (VRS) at 10-minute intervals for the 30 minutes of recovery. VRS is a scale from 0 to 10 where 0 signifies no pain and 10 signifies the worst pain ever experienced.	At 10-minute intervals during the first 30 minutes after extubation.