Purpose

Etomidate and ketamine are hemodynamically stable induction agents often used to sedate critically ill patients during emergency endotracheal intubation. In 2015, quality improvement data from our hospital suggested a survival benefit at Day 7 from avoidance of etomidate in critically ill patients during emergency intubation. In this clinical trial, we hypothesized that randomization to ketamine instead of etomidate would be associated with Day 7 survival after emergency endotracheal intubation.

Methods

A prospective, randomized, open-label, parallel assignment, single-center clinical trial performed by an anesthesiology-based Airway Team under emergent circumstances at one high-volume medical center in the United States. 801 critically ill patients requiring emergency intubation were randomly assigned 1:1 by computer-generated, pre-randomized sealed envelopes to receive etomidate (0.2–0.3 mg/kg, n = 400) or ketamine (1–2 mg/kg, n = 401) for sedation prior to intubation. The pre-specified primary endpoint of the trial was Day 7 survival. Secondary endpoints included Day 28 survival.

Results

Of the 801 enrolled patients, 396 were analyzed in the etomidate arm, and 395 in the ketamine arm. Day 7 survival was significantly lower in the etomidate arm than in the ketamine arm (77.3% versus 85.1%, difference − 7.8, 95% confidence interval − 13, − 2.4, p = 0.005). Day 28 survival rates for the two groups were not significantly different (etomidate 64.1%, ketamine 66.8%, difference − 2.7, 95% confidence interval − 9.3, 3.9, p = 0.294).

Conclusion

While the primary outcome of Day 7 survival was greater in patients randomized to ketamine, there was no significant difference in survival by Day 28.

中文翻译：

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依托咪酯与氯胺酮用于紧急气管插管：一项随机临床试验

目的

依托咪酯和氯胺酮是血流动力学稳定的诱导剂，通常用于在紧急气管插管期间镇静危重病人。2015 年，我们医院的质量改进数据表明，危重患者在紧急插管期间避免使用依托咪酯可提高第 7 天的生存率。在这项临床试验中，我们假设随机分配到氯胺酮而不是依托咪酯与紧急气管插管后的第 7 天存活率相关。

方法

一项前瞻性、随机、开放标签、平行分配、单中心临床试验，由基于麻醉学的气道团队在美国一家大容量医疗中心的紧急情况下进行。801 名需要紧急插管的重症患者通过计算机生成的预随机密封信封以 1:1 的比例随机分配接受依托咪酯（0.2-0.3 mg/kg，n = 400）或氯胺酮（1-2 mg/kg，n = 401) 用于插管前的镇静。该试验预先指定的主要终点是第 7 天的存活率。次要终点包括第 28 天的存活率。

结果

在 801 名入组患者中，依托咪酯组分析了 396 名，氯胺酮组分析了 395 名。依托咪酯组的第 7 天存活率明显低于氯胺酮组（77.3% 对 85.1%，差异 − 7.8，95% 置信区间 − 13，− 2.4，p = 0.005）。两组的第 28 天存活率没有显着差异（依托咪酯 64.1%，氯胺酮 66.8%，差异 − 2.7，95% 置信区间 − 9.3、3.9，p = 0.294）。

结论

虽然第 7 天生存的主要结果在随机接受氯胺酮的患者中更高，但第 28 天的生存率没有显着差异。