【罂粟摘要】可乐定预防婴儿紧急躁动（预防躁动II)：一项方案和统计分析计划

可乐定预防婴儿紧急躁动（预防躁动II)：一项方案和统计分析计划

贵州医科大学    麻醉与心脏电生理课题组

翻译:文春雷     编辑：柏雪     审校：曹莹

背景：急症性躁动是儿童常见的临床症状。术后早期出现的不良症状通常发生在麻醉苏醒期。可乐定是预防儿童出现躁动的有效辅助药物，但最小年龄的使用研究很少。我们的目的是调查术中静脉注射可乐定预防3-12个月大的儿童出现躁动的有效性和安全性。

方法：这是一项随机、安慰剂对照、双盲试验。我们将招募320名年龄在3-12个月的患者，计划使用七氟醚和阿片类药物维持全身麻醉。随机分组，并按年龄、性别和地点进行分层。该研究性药物将在手术结束前20 min静脉注射。干预措施为可乐定3 μg/kg，安慰剂为相应体积的等渗生理盐水。

结果：主要结局是根据Watcha量表评估的出现躁动的发生率，即参与者在麻醉后护理病房期间的任何Watcha评分 2。次要结局是术后疼痛、恶心和呕吐的患者比例，以及复合安全结局。统计分析将根据统计分析计划进行，并对意向治疗人群进行初步分析。

结论：预防躁动II试验将有助于为预防婴儿紧急躁动的有效性和安全性提供临床指导。

原始文献来源

Anne Louise de Barros Garioud, Bettina Nygaard Nielsen,Lars Falcon,et al.Clonidine for preventing emergence agitation in infants(PREVENT AGITATION II): Protocol and statistical analysis plan.[J].BMC Anesthesiology 2023;1-7.

英文原文：

Clonidine for preventing emergence agitation in infants

(PREVENT AGITATION II): Protocol and statistical analysis plan

Background: Emergence agitation is a common clinical condition in children. Symptoms pertaining to the spectrum of early postoperative negative behavior typically occur upon emergence from anesthesia. Clonidine is an effective adjunctive agent for the prevention of emergence agitation in children, but evidence in the smallest age groups is sparse We aim to investigate the efficacy and safety of an intraoperative bolus of intravenous clonidine for preventing emergence agitation in children 3–12 months of age.

Methods: This is a randomized, placebo-controlled, double-blind trial. We will enroll 320 patients aged 3–12 months who have been scheduled for general anesthesia maintained with sevoflurane and opioid. The randomization is parallel and stratified by age group, sex, and site. The investigational medicinal product will be administered intravenously  20 min before the anticipated end of the surgical procedure. The intervention is clonidine 3 μg/kg and placebo is isotonic saline in a corresponding volume.

Results: The primary outcome is the incidence of emergence agitation as assessed on the Watcha scale, that is, any Watcha score 2 during participants' stay in the postanesthetic care unit. Secondary outcomes are the proportion of participants with postoperative pain, with postoperative nausea and vomiting, and a composite safety outcome. Statistical analysis will be conducted according to the Statistical Analysis Plan with the intention-to-treat population for our primary analyses.

Conclusion: The PREVENT AGITATION II trial will contribute valuable knowledge on efficacy for the prevention of emergence agitation and safety in infants.