【罂粟摘要】去甲肾上腺素与去氧肾上腺素治疗成人非心脏手术患者全麻期间低血压：一项多中心、开放标签、随机、交叉、可行性和先导性试验

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去甲肾上腺素与去氧肾上腺素治疗成人非心脏手术患者全麻期间低血压：一项多中心、开放标签、随机、交叉、可行性和先导性试验

贵州医科大学    麻醉与心脏电生理课题组

翻译：佟睿

编辑：宋雨婷

审校：曹莹

背景

术中低血压与术后并发症相关。通常需要使用血管升压药来纠正低血压，但最好的血管升压药尚不清楚。

方法

在加利福尼亚州的五家医院进行了一项多中心、整群随机、交叉、可行性和试点试验。在全麻患者中，去氧肾上腺素(PE)和去甲肾上腺素(NE)作为一线血管升压药在每家医院使用为期6个月，每月进行交替。主要观察指标是一线血管升压药给药依从性达到80%或更高。次要观察指标为急性肾损伤(AKI)、30天死亡率、非心脏手术后心肌损伤(MINS)、住院时间和30天内再住院情况。

结果

总共有3626名患者在6个月内入组；NE组被随机分入1809名患者，PE组被随机分入1817名患者。总体而言，88.2%的患者接受了分配的一线血管升压药。两组均未发生需要处理的渗药。患者年龄中位数为63岁，50%为女性，58%为白人。NE组与PE组的随机对照并未降低30天内再入院(调整后的优势比为0.92；95%可信区间为0.6-1.39)、30天死亡率(1.01；0.48-2.09)、AKI(1.1；0.92-1.31)或MINS(1.63；0.84-3.16)。

结论

在全麻下接受大手术的大数据不同人群入组，并随机接受NE或PE输注。这项先导性、可行性试验无法针对术后不良结果提供指导，计划进行一项后续的多中心有效性试验。

原始文献来源

Matthieu Legrand, Rishi Kothari, Nicholas Fong, et al. Norepinephrine versus phenylephrine for treating hypotension during general anaesthesia in adult patients undergoing major noncardiac surgery: a multicentre, open-label, cluster-randomised, crossover, feasibility, and pilot trial. [J]Br J Anae, doi: 10.1016/j.bja.2023.02.004.

英文原文

Norepinephrine versus phenylephrine for treating hypotension during general anaesthesia in adult patients undergoing major noncardiac surgery: a multicentre, open-label, cluster-randomised, crossover, feasibility, and pilot trial

Background: Intraoperative hypotension is associated with postoperative complications. The use of vasopressors is often required to correct hypotension but the best vasopressor is unknown.

Method: A multicentre, cluster-randomised, crossover, feasibility and pilot trial was conducted across five hospitals in California. Phenylephrine (PE) vs norepinephrine (NE) infusion as the first-line vasopressor in patients under general anaesthesia alternated monthly at each hospital for 6 months. The primary endpoint was first-line vasopressor administration compliance of 80% or higher. Secondary endpoints were acute kidney injury (AKI), 30-day mortality, myocardial injury after noncardiac surgery (MINS), hospital length of stay, and rehospitalisation within 30 days.

Results: A total of 3626 patients were enrolled over 6 months; 1809 patients were randomised in the NE group, 1817 in the PE group. Overall, 88.2% received the assigned first-line vasopressor. No drug infiltrations requiring treatment were reported in either group. Patients were median 63 yr old, 50% female, and 58% white. Randomisation in the NE group vs PE group did not reduce readmission within 30 days (adjusted odds ratio=0.92; 95% confidence interval, 0.6-1.39), 30-day mortality (1.01; 0.48-2.09), AKI (1.1; 0.92-1.31), or MINS (1.63; 0.84-3.16).

Conclusion: A large and diverse population undergoing major surgery under general anaesthesia was successfully enrolled and randomised to receive NE or PE infusion. This pilot and feasibility trial was not powered for adverse postoperative outcomes and a follow-up multicentre effectiveness trial is planned.

-End-

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