Dataset Information

Fentanyl versus placebo with ketamine and rocuronium for patients undergoing rapid sequence intubation in the emergency department: The FAKT study-A randomized clinical trial.

ABSTRACT:

Objective

The objective was to determine whether the use of fentanyl with ketamine for emergency department (ED) rapid sequence intubation (RSI) results in fewer patients with systolic blood pressure (SBP) measurements outside the pre-specified target range of 100-150 mm Hg following the induction of anesthesia. Methods This study was conducted in the ED of five Australian hospitals. A total of 290 participants were randomized to receive either fentanyl or 0.9% saline (placebo) in combination with ketamine and rocuronium, according to a weight-based dosing schedule. The primary outcome was the proportion of patients in each group with at least one SBP measurement outside the prespecified range of 100-150 mm Hg (with adjustment for baseline abnormality). Secondary outcomes included first-pass intubation success, hypotension, hypertension and hypoxia, mortality, and ventilator-free days 30 days following enrollment.

Results

A total of 142 in the fentanyl group and 148 in the placebo group commenced the protocol. A total of 66% of patients receiving fentanyl and 65% of patients receiving placebo met the primary outcome (difference = 1%, 95% CI = -10 to 12). Hypotension (SBP ≤ 99 mm Hg) was more common with fentanyl (29% vs. 16%; difference = 13%, 95% CI = 3% to 23%), while hypertension (≥150 mm Hg) occurred more with placebo (69% vs. 55%; difference = 14%, 95% CI = 3 to 24). First-pass success rate, 30 day mortality, and ventilator-free days were similar.

Conclusions and relevance

There was no difference in the primary outcome between groups, although lower blood pressures were more common with fentanyl. Clinicians should consider baseline hemodynamics and postinduction targets when deciding whether to use fentanyl as a coinduction agent with ketamine.

SUBMITTER: Ferguson I

PROVIDER: S-EPMC9314707 | biostudies-literature |

REPOSITORIES: biostudies-literature

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Project description:Succinylcholine and rocuronium are widely used to facilitate rapid sequence induction (RSI) intubation in intensive care. Concerns relate to the side effects of succinylcholine and to slower onset and inferior intubation conditions associated with rocuronium. So far, succinylcholine and rocuronium have not been compared in an adequately powered randomized trial in intensive care. Accordingly, the aim of the present study was to compare the incidence of hypoxemia after rocuronium or succinylcholine in critically ill patients requiring an emergent RSI.This was a prospective randomized controlled single-blind trial conducted from 2006 to 2010 at the University Hospital of Basel. Participants were 401 critically ill patients requiring emergent RSI. Patients were randomized to receive 1 mg/kg succinylcholine or 0.6 mg/kg rocuronium for neuromuscular blockade. The primary outcome was the incidence of oxygen desaturations defined as a decrease in oxygen saturation ? 5%, assessed by continuous pulse oxymetry, at any time between the start of the induction sequence and two minutes after the completion of the intubation. A severe oxygen desaturation was defined as a decrease in oxygen saturation ? 5% leading to a saturation value of ? 80%.There was no difference between succinylcholine and rocuronium regarding oxygen desaturations (succinylcholine 73/196; rocuronium 66/195; P = 0.67); severe oxygen desaturations (succinylcholine 20/196; rocuronium 20/195; P = 1.0); and extent of oxygen desaturations (succinylcholine -14 ± 12%; rocuronium -16 ± 13%; P = 0.77). The duration of the intubation sequence was shorter after succinycholine than after rocuronium (81 ± 38 sec versus 95 ± 48 sec; P = 0.002). Intubation conditions (succinylcholine 8.3 ± 0.8; rocuronium 8.2 ± 0.9; P = 0.7) and failed first intubation attempts (succinylcholine 32/200; rocuronium 36/201; P = 1.0) did not differ between the groups.In critically ill patients undergoing emergent RSI, incidence and severity of oxygen desaturations, the quality of intubation conditions, and incidence of failed intubation attempts did not differ between succinylcholine and rocuronium.ClinicalTrials.gov, number NCT00355368.

Project description:ImportanceRocuronium and succinylcholine are often used for rapid sequence intubation, although the comparative efficacy of these paralytic agents for achieving successful intubation in an emergency setting has not been evaluated in clinical trials. Succinylcholine use has been associated with several adverse events not reported with rocuronium.ObjectiveTo assess the noninferiority of rocuronium vs succinylcholine for tracheal intubation in out-of-hospital emergency situations.Design, setting and participantsMulticenter, single-blind, noninferiority randomized clinical trial comparing rocuronium (1.2 mg/kg) with succinylcholine (1 mg/kg) for rapid sequence intubation in 1248 adult patients needing out-of-hospital tracheal intubation. Enrollment occurred from January 2014 to August 2016 in 17 French out-of-hospital emergency medical units. The date of final follow-up was August 31, 2016.InterventionsPatients were randomly assigned to undergo tracheal intubation facilitated by rocuronium (n = 624) or succinylcholine (n = 624).Main outcomes and measuresThe primary outcome was the intubation success rate on first attempt. A noninferiority margin of 7% was chosen. A per-protocol analysis was prespecified as the primary analysis.ResultsAmong 1248 patients who were randomized (mean age, 56 years; 501 [40.1%] women), 1230 (98.6%) completed the trial and 1226 (98.2%) were included in the per-protocol analysis. The number of patients with successful first-attempt intubation was 455 of 610 (74.6%) in the rocuronium group vs 489 of 616 (79.4%) in the succinylcholine group, with a between-group difference of -4.8% (1-sided 97.5% CI, -9% to ∞), which did not meet criteria for noninferiority. The most common intubation-related adverse events were hypoxemia (55 of 610 patients [9.0%]) and hypotension (39 of 610 patients [6.4%]) in the rocuronium group and hypoxemia (61 of 616 [9.9%]) and hypotension (62 of 616 patients [10.1%]) in the succinylcholine group.Conclusions and relevanceAmong patients undergoing endotracheal intubation in an out-of-hospital emergency setting, rocuronium, compared with succinylcholine, failed to demonstrate noninferiority with regard to first-attempt intubation success rate.Trial registrationClinicalTrials.gov Identifier: NCT02000674.