Effect of Remifentanil vs Neuromuscular Blockers During Rapid Sequence Intubation on Successful Intubation Without Major Complications Among Patients at Risk of Aspiration: A Randomized Clinical Trial
An erratum to this article was published (JAMA, 14 Feb 2023 ↗)
Primary result · Successful intubation on first attempt without major complications (as-randomized population)Result — go to the resultBetween-group difference adjusted for randomization strata and center −6.1% 95% CI −11.6% to −0.5%Authors' conclusion
Among adults at risk of aspiration during rapid sequence intubation in the operating room, remifentanil, compared with neuromuscular blockers, did not meet the criterion for noninferiority with regard to successful intubation on first attempt without major complications.
Study context
- Population
- Adults at risk of aspiration (fasting <6 hours, bowel occlusion, recent trauma, or severe gastroesophageal reflux) undergoing tracheal intubation in the operating room, 15 hospitals in France, October 2019 to April 20211,130 (98.3%) completed
- Participants
- 1,150 adults
- Comparison
- Remifentanil vs Neuromuscular blockers
- Remifentaniln = 575
- Neuromuscular blockersn = 575reference
- Primary endpoint
- Successful tracheal intubation on first attempt without major complications (lung aspiration of digestive content, oxygen desaturation, major hemodynamic instability, sustained arrhythmia, cardiac arrest, severe anaphylactic reaction)
Methodological detailsmulticentre, open-label, noninferiority
- Multicentre
- Open-label
- Noninferiority
Primary result
As reported in the abstract
Successful intubation on first attempt without major complications (as-randomized population)
Between-group difference adjusted for randomization strata and center
−6.1%
95% CI −11.6% to −0.5%
P = 0.37 for noninferiority
Events by treatment group
Remifentanil vs Neuromuscular blockers
between-group difference adjusted for randomization strata and center −6.1% (95% CI −11.6% to −0.5%); P = 0.37 for noninferiority
Further findings
| Outcome | Remifentanil | Neuromuscular blockers | Adjusted difference (95% CI) | P value | |
|---|---|---|---|---|---|
| Successful intubation on first attempt without major complications (per-protocol population)2-sided CI · per-protocol population | 66.2% | 71.3% | −5.7% (−11.3% to −0.1%) | P = 0.32 for noninferiority | |
| −15−10−505Difference (linear scale) |
Safety
| Outcome | Remifentanil | Neuromuscular blockers | Adjusted difference (95% CI) | |
|---|---|---|---|---|
| Adverse event of hemodynamic instability | 3.3% | 0.5% | 2.8% (1.2%–4.4%) | |
| −20246Difference (linear scale) |
Original publication
Effect of Remifentanil vs Neuromuscular Blockers During Rapid Sequence Intubation on Successful Intubation Without Major Complications Among Patients at Risk of Aspiration: A Randomized Clinical Trial. JAMA. Published 3 January 2023. doi:10.
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