【文献阅读】作为多模式抗焦虑治疗的一部分，口服褪黑素（而非咪达唑仑）可减少儿童苏醒期谵妄的发生

文献摘要

BACKGROUND Pre-operative anxiety is a risk factor for emergence delirium in children and a multimodal approach including sedatives and nonpharmacological measures is the current strategy to tackle this anxiety. The efficacy of oral melatonin as a component of multimodal anxiolytic strategy to decrease emergence delirium is not well studied.

背景：术前焦虑是儿童发生苏醒期谵妄的一个危险因素，包括镇静剂和非药物措施在内的多模式方案是解决这种焦虑的当前策略。作为多模式抗焦虑治疗的一部分，口服褪黑素减少苏醒期谵妄的疗效尚未得到很好的研究。

OBJECTIVE The aim of this study was to evaluate the efficacy of a multimodal anxiolytic strategy including oral melatonin or midazolam to decrease emergence delirium after sevoflurane anaesthesia.

目的：本研究旨在评估包括口服褪黑素或咪达唑仑在内的多模式抗焦虑治疗对减少七氟醚麻醉后出现的苏醒期谵妄的治疗疗效。

DESIGN A randomised, double-blind, parallel arm, placebocontrolled trial.

设计：一项随机、双盲、平行、安慰剂对照试验。

SETTING Tertiary care teaching hospital from July 2019 till January 2020.

范围设置：从2019年7月至2020年1月在三级护理教学医院。

PARTICIPANTS Children in the age group of 3 to 8 years who received sevoflurane anaesthesia for elective ambulatory procedures.

受试对象：3至8岁年龄组的儿童，他们接受七氟醚麻醉以进行择期日间手术。

INTERVENTIONS Children were randomised to receive oral premedication with either melatonin 0.3 mg kg^-1, midazolam 0.3 mg kg^-1or honey as placebo. All the children received standardised nonpharmacological measures involving multiple techniques to allay anxiety. The anaesthetic plan was also standardised.

干预措施：儿童随机接受术前口服褪黑素0.3 mg kg^-1、咪达唑仑0.3 mg kg^-1或蜂蜜（作为安慰剂）。所有儿童都接受了标准化的非药物治疗，包括多种缓解焦虑的技术。采用标准化的麻醉方案。

MAIN OUTCOME MEASURES The primary outcome was the incidence of emergence delirium as assessed by the Watcha scale in the postanaesthesia care unit. The secondary outcomes were pre-operative anxiety assessed using a modified Yale Preoperative Anxiety scale,patient compliance with mask induction using the Induction Compliance Checklist and postoperative sedation.

主要观察指标：主要观察指标是在麻醉后恢复室中通过Watcha量表评估的苏醒期谵妄的发生率。次要观察指标是使用改良的耶鲁术前焦虑量表评估术前焦虑，使用诱导依从性检查表评估患者对面罩诱导的依从性，以及术后镇静。

RESULTS Data from 132 children were analysed. Melatonin significantly reduced the incidence of emergence delirium compared to placebo: 27 vs. 50%, respectively, an absolute risk reduction of 23.3 [95% confidence interval 3.7 to 42.9), P=0.03]. Melatonin also significantly reduced the risk of emergence delirium compared with midazolam: 27 vs. 56%, respectively, an absolute risk reduction of 29.2 (95% CI 9.5 to 48.8). The midazolam group had a similar incidence of emergence delirium as placebo. Sedation scores were similar in the three groups postoperatively. The incidence and score of pre-operative anxiety as well as the compliance with mask induction were similar in the three groups.

结果：对132名儿童的资料进行了分析。与安慰剂相比，褪黑素显著降低了苏醒期谵妄的发生率：分别为27%和50%，绝对风险降低23.3[95%置信区间3.7 - 42.9），P=0.03]。与咪达唑仑相比，褪黑素也显著降低了苏醒期谵妄的发生风险：分别为27%和56%，绝对风险降低29.2（95%置信区间9.5 - 48.8）。咪唑安定组苏醒期谵妄的发生率与安慰剂组相似。三组术后镇静评分相似。三组患者术前焦虑的发生率和评分以及对面罩诱导的依从性相似。

CONCLUSIONS A multimodal anxiolytic approach including oral melatonin, as opposed to oral midazolam, significantly reduced emergence delirium after sevoflurane anaesthesia.

结论：与口服咪达唑仑相比，包括口服褪黑素在内的多模式抗焦虑治疗可显著减少七氟醚麻醉后苏醒期谵妄的发生。

图1 试验流程图

     

表1 术前和术中特征

     

表2 苏醒期谵妄的发生和芬太尼使用情况

     

表3 苏醒期谵妄的绝对风险、相对风险和风险降低

     

表4 诱导前和诱导中的焦虑特征

文献笔记

1.纳入排除标准

     

2.麻醉流程

     

3.结局指标

1.医学研究常见设计类型

     

2.随机对照研究基本分析策略

小记英文

Emergence delirium 苏醒期谵妄

Hypnotics 安眠药；催眠药

Urogenital 泌尿生殖器的

Caudal block 骶管阻滞

Penile block 阴茎阻滞

Inhalation anesthesia 吸入麻醉

Induction 诱导

General anesthesia 全身麻醉