静脉、吸入或联合麻醉维持对儿童腺样体扁桃体切除术后呼吸不良事件的影响(AmPRAEC研究):一项多中心随机临床试验

贵州医科大学 麻醉与心脏电生理课题组

翻译:周倩 编辑:周倩  审校:曹莹

背景

全身麻醉药物可能影响儿童术后呼吸系统不良事件(PRAEs)的风险,但麻醉维持策略对这些事件的影响尚未得到广泛验证。本研究旨在验证以下假设:在吸入麻醉基础上联合丙泊酚输注或单独使用丙泊酚输注的麻醉维持策略,可逐步降低PRAE的发生率。

方法

本研究为多中心随机对照试验,纳入中国12家医院的760例0-12岁接受腺样体扁桃体切除术的儿童。患者随机分为IV组(丙泊酚维持)、IVIH组(丙泊酚+七氟烷维持)和IH组(七氟烷维持)。所有患儿均采用气管插管进行气道管理,并在清醒状态下拔管。主要结局指标为术后麻醉恢复室中术后不良事件(PRAEs)的发生率。

结果 

【罂粟摘要】静脉、吸入或联合麻醉维持对儿童腺样体扁桃体切除术后呼吸不良事件的影响(AmPRAEC研究):一项多中心随机临床试验

共760名儿童(中位年龄[四分位间距]为6[4至7]岁;460名男孩[60.5%])被随机分组,共有729份样本可用于改良的意向性治疗分析。IV组的PRAE发生率最低(239例中的45例[18.8%]),其次是 IVIH 组(246例中的70例[28.5%])和IH组(244例中的106例[43.4%])。与IH组相比,IVIH组PRAEs风险降低56%(aOR=0.44,95% CI 0.29-0.65),IV组风险降低75%(aOR=0.25,95% CI 0.16-0.39)。

 结论 

丙泊酚静脉麻醉维持可显著降低儿童腺样体扁桃体切除术后的PRAEs风险,且效果优于静脉-吸入联合或单纯吸入麻醉。对于高风险患儿,推荐优先选择丙泊酚静脉麻醉维持方案。

原始文献Shen F, Zhang L, Wang X, et al. Effect of Intravenous, Inhalational, or Combined Anesthesia Maintenance on Postoperative Respiratory Adverse Events in Children Undergoing Adenotonsillectomy (AmPRAEC): A Multicenter Randomized Clinical Trial. Anesthesiology. 2025 Oct 14;143(6):1484–96. doi: 10.1097/ALN.0000000000005707. Epub ahead of print. PMID: 40768554; PMCID: PMC12594160.

Effect of Intravenous, Inhalational, or Combined Anesthesia Maintenance on Postoperative Respiratory Adverse Events in Children Undergoing Adenotonsillectomy (AmPRAEC): A Multicenter Randomized Clinical Trial

ABSTRACT

Background: General anesthetic drugs may affect the risk of postoperative respiratory adverse events (PRAEs) in children, but the effect of anesthesia maintenance strategies on these events has not yet been widely validated. This study tested the hypothesis that anesthesia maintenance with propofol infusion in addition to inhalation anesthesia or alone would lead to a progressive reduction in the incidence of PRAEs.

Methods: This multicenter randomized clinical trial (AmPRAEC study) enrolled 760 children aged 0 to 12 yr who underwent adenotonsillectomy at 12 hospitals in China. Patients were randomly assigned to the intravenous anesthesia maintenance (IV group), the combined intravenous-inhalation anesthesia maintenance (IVIH group), or the inhalation anesthesia maintenance (IH group). Tracheal tubes were used for airway management, with all children undergoing awake extubation. The primary outcome was PRAE incidence in the postanesthesia care unit.

Results: A total of 760 children (median [interquartile range] age, 6 [4 to 7] years; 460 boys [60.5%]) were randomized, and 729 total samples were available for modified intention-to-treat analysis. The IV group had the lowest incidence of PRAEs (45 of 239 [18.8%]), followed by the IVIH group (70 of 246 [28.5%]) and the IH group (106 of 244 [43.4%]). Compared to the IH group, the IVIH group had a significantly lower risk of PRAEs (adjusted odds ratio [aOR], 0.44; 95% confidence interval [CI], 0.29 to 0.65; number needed to treat, 7). The IV group had significantly lower risk compared to both the IVIH group (aOR, 0.57; 95% CI, 0.36 to 0.90; number needed to treat, 6) and the IH group (aOR, 0.25; 95% CI, 0.16 to 0.39; number needed to treat, 3).

Conclusions: Anesthesia maintenance with propofol infusion in addition to inhalation anesthesia or alone resulted in a progressive reduction in the incidence of PRAEs. Propofol intravenous anesthesia maintenance should be considered for children undergoing adenotonsillectomy.

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