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[JAMA发表论文]:院外快速顺序诱导使用罗库溴铵或琥珀酰胆碱对气管插管成功率的影响
2019年12月26日 时讯速递, 进展交流 暂无评论

Original Investigation December 17, 2019

Effect of Rocuronium vs Succinylcholine on Endotracheal Intubation Success Rate Among Patients Undergoing Out-of-Hospital Rapid Sequence IntubationA Randomized Clinical Trial

Bertrand Guihard, Charlotte Chollet-Xémard, Philippe Lakhnati, et al

JAMA. 2019;322(23):2303-2312. doi:10.1001/jama.2019.18254

Importance 背景

Rocuronium 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.

罗库溴铵及琥珀酰胆碱常用于快速顺序诱导,但在紧急情况下这两种肌松药物对成功插管的影响从未经过临床试验验证。罗库溴铵没有琥珀酰胆碱的某些副作用。

Objective 目的

To assess the noninferiority of rocuronium vs succinylcholine for tracheal intubation in out-of-hospital emergency situations.

评估在院外紧急情况下气管插管使用罗库溴铵是否不劣于琥珀酰胆碱。

Design, Setting and Participants 试验设计,场景及研究人群

Multicenter, 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.

多中心,单盲,非劣效随机临床实践,对1248名院外气管插管患者快速顺序诱导时比较罗库溴铵(1.2 mg/kg) 与琥珀酰胆碱 (1 mg/kg)的效果。2014年1月至2016年8月间,在法国17个院外急诊医疗单元纳入患者。最后随访日期为2016年8月31日。

Interventions 干预措施

Patients were randomly assigned to undergo tracheal intubation facilitated by rocuronium (n = 624) or succinylcholine (n = 624).

患者接受气管插管时随机使用罗库溴铵(n = 624) 或琥珀酰胆碱 (n = 624)。

Main Outcomes and Measures 主要预后指标

The 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.

主要预后指标为首次气管插管成功率。选择非劣效边际为7%。预先确定采用符合方案集为主要分析。

Results 结果

Among 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.

共有1248名患者接受随机分组 (平均年龄, 56 岁; 501 名 [40.1%] 女性),1230名 (98.6%) 患者完成试验,1226名 (98.2%) 患者纳入符合方案集分析。罗库溴铵组610名患者中455名 (74.6%) 及琥珀酰胆碱组616名患者中489名(79.4%)首次插管成功,组间差异−4.8% (单尾97.5% CI, −9% to ∞),不满足非劣效标准。罗库溴铵组和琥珀酰胆碱组最常见的插管相关不良事件为低氧血症 (55/610 [9.0%] vs. 61/616 [9.9%]) 和低血压 (39/610 [6.4%] vs. 62/616 [10.1%])。

Conclusions and Relevance 结论与意义

Among 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.

对于接受院外紧急情况下气管插管的患者,与琥珀酰胆碱相比,罗库溴铵对首次插管成功率的影响并未显示非劣效。

Trial Registration 试验注册

ClinicalTrials.gov Identifier: NCT02000674

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