Nociceptive Pain
Conditions
Keywords
NOL, Nociception
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.
Interventions
DEVICENOL 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
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
Sponsors
Medasense Biometrics Ltd
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, 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
Intervention model description
NOL-Guided analgesia vs. Routine Management
Eligibility
Sex/Gender
ALL
Age
21 Years to 85 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
United States
Outcome results
None listed