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

Nociceptive Pain Clinical Trial

Official title:

Postoperative Benefits of Intraoperative NOL Titration - Pilot

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04305015
• Other study ID #: CLI-20-01
• Status: Completed
• Phase: N/A
• Start date: November 9, 2020
• Est. completion date: December 30, 2020

Study information

• Verified date: April 2021
• Source: Medasense Biometrics Ltd
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 26
• Est. completion date: December 30, 2020
• Est. primary completion date: December 30, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years to 85 Years

Eligibility

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

Related Conditions & MeSH terms

• Nociceptive Pain

Intervention

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:
• 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

Locations

Country	Name	City	State
United States	Cleveland clinic	Cleveland	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
Medasense Biometrics Ltd

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	60 minutes during recovery