Grillot N, Lebuffe G, Huet O et al.
JAMA 2023, 329 (1):28-38
AIM OF STUDY
To determine whether remifentanil is noninferior to rapid onset NMBs for RSI in patients at risk of aspiration
DESIGN (& LOCATION)
Mutlicentre, open label, randomised noninferiority control trial (France)
METHODOLOGY
Recruited 2019 -2021 in 15 French hospitals. Online randomisation immediately prior to procedure, in blocks of 4-6, stratified by choice of laryngoscopic technique (DL vs VL) and presence of bowel obstruction (Y/N)
Patients received 3 minutes of preoxygenation, followed by bolus of hypnotic, then either a bolus of remifentanil (3-4ug/kg) or neuromuscular blocker immediately afterwards, and intubation attempted at 30-60s in both groups
PRIMARY OUTCOME
Successful tracheal intubation rate on 1st attempt, without any major complications
SECONDARY OUTCOMES
Oesophageal intubations / time to apnoea / time to successful intubation / rescue treatment use / Cormack/Lehane grade / % glottic opening visible/ BURP use / Difficulty Score / Mechanical Cx / Sore throat / ITU / D7 – pneumonia, ARDS / in hosp mortality
STATISTICS
1150 total / 575 each arm / 80% power for 95% 2-sided CI
7% noninferiority margin preset
Absolute & adjusted effects calculated
Adjusted proportion & relative CIS – mixed-effects logistic regression model – taking into account DL/VL & bowel obstruction Y/N + accounting for centre variation
Subgroup analysis – adjusted logistic regression with same adjustment variables except when they defined a subgroup (ie bowel obstruction)
Secondary outcomes – mixed effects logistic regression
RESULTS
Tracheal intubation on the first attempt without major complications:
- 374/575 patients (66.1%) in the remifentanil group
- 408/575 (71.6%) in the NMB group
- (between-group difference adjusted for randomization strata and center, –6.1%; 95% CI, –11.6% to –0.5%; P = .37 for noninferiority), demonstrating inferiority.
Hemodynamic instability:
- 19/575 patients (3.3%) with remifentanil
- 3/575 patients (0.5%) with NMBs
- (adjusted difference, 2.8%; 95% CI, 1.2%-4.4%)
CONCLUSIONS/DISCUSSION
Amongst adults at risk of aspiration, remifentanil did not meet noninferiority criteria vs NMB for 1st attempt successful intubation without major complications
Note wide confidence intervals (ie that include noninferior effect) therefore difficult to draw clinical relevance
STATED LIMITATIONS FROM STUDY
Acknowledged:
Open label – fasciculations with Sux
Quantification of risk factors
Generalisable out of theatre environment?
Low rate of stylet use in 1st attempt
Learning curve of use of remi? (no trend to suggest this in data)
Other:
Use of bolus remifentanil vs TCI infusion (dose effect of remifentanil?)
Lack of opiate in NMB group
Sux as 1st line – representative of UK practise?
Breakdown of HD instability?
DISCUSSION FROM JOURNAL CLUB MEETING (? Change of practice)
– Those who have used remi bolus have found patients have significant HD instability
– More commonly used as infusion than bolus when not using NMB – ?relevance of this study for that
– Study possibly shows a dose effect of remi, which would be interesting to tease out further
Summary by Dr L Parker. Journal Club Meeting on 19th January 2023.
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