Intraoperative NOL Titration

Sponsor

The Cleveland Clinic (Other)

Overall Status

Active, not recruiting

CT.gov ID

NCT04679818

Collaborator

(none)

144

Enrollment

Location

Arms

Anticipated Duration (Months)

4.6

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Anesthesia; Adverse Effect	Drug: Routine opioid management Device: PMD-200 Nol-guided opioid administration	Phase 3

Detailed 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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

144 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Investigator, Outcomes Assessor)

Primary Purpose:

Prevention

Official Title:

Postoperative Consequences of Intraoperative NOL Titration

Actual Study Start Date :

Dec 30, 2020

Anticipated Primary Completion Date :

Dec 1, 2022

Anticipated Study Completion Date :

Aug 1, 2023

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Control Group Clinicians will be blinded to PMD-200 NOL monitoring and use clinical judgement to determine how much fentanyl should be given, and when.	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 Other Names: PMD-200 NOL
Active Comparator: PMD-200 NOL group Clinicians will titrate fentanyl to keep PMD-200 NOL under 25 - always using good clinical judgement for individual patients	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. Other Names: Fentanyl

Arm

Intervention/Treatment

Active Comparator: Control Group

Clinicians will be blinded to PMD-200 NOL monitoring and use clinical judgement to determine how much fentanyl should be given, and when.

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

Other Names:

PMD-200 NOL

Active Comparator: PMD-200 NOL group

Clinicians will titrate fentanyl to keep PMD-200 NOL under 25 - always using good clinical judgement for individual patients

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.

Other Names:

Fentanyl

Outcome Measures

Primary Outcome Measures

Pain Scores [60 minutes]
The investigators will evaluate the pain scores at 10-minute using pain scores (0-10 verbal response scale)

Secondary Outcome Measures

Pain Scores <5. [60 minutes]
The investigators will evaluate whether or not the pain score at any measured interval is < 5, using (0-10 verbal response scale)

Eligibility Criteria

Criteria

Ages Eligible for Study:

21 Years to 85 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Cleveland Clinic	Cleveland	Ohio	United States	44195

Sponsors and Collaborators

The Cleveland Clinic

Investigators

Principal Investigator: Kurt Ruetzler, MD, The Cleveland Clinic

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

The Cleveland Clinic

ClinicalTrials.gov Identifier:

NCT04679818

Other Study ID Numbers:

19-1646

First Posted:

Dec 22, 2020

Last Update Posted:

Mar 8, 2022

Last Verified:

Mar 1, 2022

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Yes

Additional relevant MeSH terms:

Fentanyl

Analgesics, Opioid

Study Results

No Results Posted as of Mar 8, 2022