Phase 3
Completed N=72
Postoperative Consequences of Intraoperative NOL Titration
Anesthesia; Adverse Effect
Source: ClinicalTrials.gov NCT04679818 ↗
Enrolled (actual)
72
Serious AEs
0.0%
Results posted
Jun 2024
Primary outcomePrimary: 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
◆ Published Evidence
Established
24citations · ~8 / year
Nociception Level Index-Guided Intraoperative Analgesia for Improved Postoperative Recovery: A Randomized Trial.
Summary
To demonstrate that intraoperative NOL-guided titration of fentanyl improves initial recovery characteristics.
Linked Publications
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Nociception Level Index-Guided Intraoperative Analgesia for Improved Postoperative Recovery: A Randomized Trial.
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 |
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) and the linked publication. 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. Informational only — not medical advice.