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

Primary Purpose

Nociceptive Pain

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
NOL Guided Analgesia
Routine opioid management
Sponsored by
Medasense Biometrics Ltd
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Nociceptive Pain focused on measuring NOL, Nociception

Eligibility Criteria

21 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Adults having major non-cardiac surgery expected to last ≥2 hours;
  2. American Society of Anesthesiologists physical status 1-3;
  3. Age 21-85 years old;
  4. Planned endotracheal intubation

Exclusion Criteria:

  1. Planned neuraxial or regional block;
  2. Local anesthetic infiltration at surgical field;
  3. Clinician preference for an opioid other than, or in addition to, fentanyl;
  4. Non-sinus heart rhythm;
  5. Neurologic condition that, in the opinion of the investigators, may preclude accurate assessment of postoperative pain and nausea;
  6. Lack of English language fluency;
  7. Routine user of psychoactive drugs other than opioids;
  8. Contraindication to sevoflurane, fentanyl, morphine, or ondansetron.
  9. Intracranial surgery
  10. BMI > 40

Sites / Locations

  • Cleveland clinic

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Routine opioid management

NOL-guided opioid administration

Arm Description

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

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

Outcomes

Primary Outcome Measures

PACU pain score
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

Secondary Outcome Measures

Full Information

First Posted
March 9, 2020
Last Updated
May 2, 2021
Sponsor
Medasense Biometrics Ltd
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1. Study Identification

Unique Protocol Identification Number
NCT04305015
Brief Title
Postoperative Benefits of Intraoperative Nociception Level (NOL) Titration - Pilot
Official Title
Postoperative Benefits of Intraoperative NOL Titration - Pilot
Study Type
Interventional

2. Study Status

Record Verification Date
April 2021
Overall Recruitment Status
Completed
Study Start Date
November 9, 2020 (Actual)
Primary Completion Date
December 30, 2020 (Actual)
Study Completion Date
December 30, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Medasense Biometrics Ltd

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Nociceptive Pain
Keywords
NOL, Nociception

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
NOL-Guided analgesia vs. Routine Management
Masking
ParticipantOutcomes 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
Allocation
Randomized
Enrollment
26 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Routine opioid management
Arm Type
Active Comparator
Arm Description
Clinicians will be blinded to NOL monitoring and use clinical judgement to determine how much fentanyl should be given, and when
Arm Title
NOL-guided opioid administration
Arm Type
Experimental
Arm Description
Clinicians will titrate fentanyl to keep NOL under 25 - always using good clinical judgement for individual patients
Intervention Type
Device
Intervention Name(s)
NOL Guided Analgesia
Other Intervention Name(s)
Physiological Monitoring Device: PMD-200 system
Intervention Description
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
Intervention Type
Other
Intervention Name(s)
Routine opioid management
Intervention Description
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
Primary Outcome Measure Information:
Title
PACU pain score
Description
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
Time Frame
60 minutes during recovery

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
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; 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
Facility Information:
Facility Name
Cleveland clinic
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44195
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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