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

Sponsor

Medasense Biometrics Ltd (Other)

Overall Status

Completed

CT.gov ID

NCT04305015

Collaborator

(none)

Enrollment

Location

Arms

1.7

Actual Duration (Months)

15.5

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Nociceptive Pain	Device: NOL Guided Analgesia Other: Routine opioid management	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

26 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

NOL-Guided analgesia vs. Routine ManagementNOL-Guided analgesia vs. Routine Management

Masking:

Double (Participant, Outcomes Assessor)

Masking Description:

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

Primary Purpose:

Treatment

Official Title:

Postoperative Benefits of Intraoperative NOL Titration - Pilot

Actual Study Start Date :

Nov 9, 2020

Actual Primary Completion Date :

Dec 30, 2020

Actual Study Completion Date :

Dec 30, 2020

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Routine opioid management 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 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
Experimental: NOL-guided opioid administration Clinicians will titrate fentanyl to keep NOL under 25 - always using good clinical judgement for individual patients	Device: NOL Guided Analgesia 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 Other Names: Physiological Monitoring Device: PMD-200 system

Arm

Intervention/Treatment

Active Comparator: Routine opioid management

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

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

Experimental: NOL-guided opioid administration

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

Device: NOL Guided Analgesia

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

Other Names:

Physiological Monitoring Device: PMD-200 system

Outcome Measures

Primary Outcome Measures

PACU pain score [60 minutes during recovery]
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

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;
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

Contacts and Locations

Locations

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

Sponsors and Collaborators

Medasense Biometrics Ltd

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Medasense Biometrics Ltd

ClinicalTrials.gov Identifier:

NCT04305015

Other Study ID Numbers:

CLI-20-01

First Posted:

Mar 12, 2020

Last Update Posted:

May 6, 2021

Last Verified:

Apr 1, 2021

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

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

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

Product Manufactured in and Exported from the U.S.:

Keywords provided by Medasense Biometrics Ltd

NOL

Nociception

Additional relevant MeSH terms:

Nociceptive Pain

Analgesics, Opioid

Study Results

No Results Posted as of May 6, 2021