Phase 3
N=72
Postoperative Consequences of Intraoperative NOL Titration
Anesthesia; Adverse Effect
Bottom Line
View on ClinicalTrials.gov: NCT04679818 ↗Enrolled (actual)
72
Serious AEs
0.0%
Results posted
Jun 2024
Primary outcome: Primary: Pain Scores at 10-minute Intervals for the Initial Hour of Recovery — 0; 0; 1.0; 5.0 score on a scale — p=0.895
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Routine opioid management (Drug); PMD-200 Nol-guided opioid administration (Device)
- Age
- Adult, Older Adult · 21+ yrs
- Sex
- All
- Sponsor
- The Cleveland Clinic
- Primary completion
- Dec 2022
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Pain Scores at 10-minute Intervals for the Initial Hour of Recovery |
0; 0; 1.0; 5.0; 2.5; 5.0 | 0.895 |
| PRIMARY Pain Scores at 10-minute Intervals for the Initial 30 Minutes of Recovery |
0; 0; 1.0; 5.0; 2.5; 5.0 | 0.228 |
| SECONDARY Number of Measurements With Pain Score Less Than 5 (vs ≥5) for Initial Hour of Recovery |
112; 130 | 0.565 |
| SECONDARY Number of Measurements With Pain Score Less Than 5 (vs ≥5) for the Initial 30 Minutes of Recovery |
63; 61 | 0.379 |
Summary
To demonstrate that intraoperative NOL-guided titration of fentanyl improves initial recovery characteristics.
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
- 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
Data sourced from ClinicalTrials.gov (NCT04679818). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.