鞘内注射咪达唑仑作为腰麻辅助药用于剖宫产术的母婴结局：一项随机对照试验的系统回顾和Meta分析
贵州医科大学 麻醉与心脏电生理课题组
翻译：潘志军 编辑：马艳燕 审校：曹莹
研究目的：为了确定在健康孕妇剖宫产腰麻中鞘内加入咪达唑仑对产妇和新生儿结局的疗效和安全性。（鞘内注射辅助药物应不含防腐剂！）
试验设计：对随机对照试验进行了Meta分析。人工搜索PubMed、Cochrane图书馆、Embase和科学网，并于2021 年5月20日完成引文筛选。
范围设置：其中大部分数据是在手术室和术后恢复区收集的。
受试人群：在19项符合条件的随机对照试验中，共纳入1382名在单次腰麻下行剖宫产的健康产妇。
干预措施：将鞘内注射咪达唑仑辅助药物与对照组进行比较，干预组和对照组在腰麻时的局麻药剂量相同。
测定方法：主要结局指标是首次使用止痛药的时间、母亲的不良反应以及新生儿1分钟和5分钟的Apgar评分。次要结果是感觉和运动阻滞的发生和持续时间。
主要结果：鞘内注射辅助药物咪达唑仑延长了首次镇痛的时间（平均差值[MD]:59.96 min，95%置信区间[CI]:[23.12，96.79]），降低了围手术期产妇恶心和/或呕吐的发生率（比值比[OR]，0.28；95%CI[0.17，0.45]）。然而，咪达唑仑组镇静相关不良事件发生率更高（OR，3.93；95%CI:[1.12，13.78]）。新生儿Apgar评分在1分钟或5分钟时无显著差异（分别为：MD:-0.29，95%CI：[−0.61, 0.03]; MD:-0.00，95%CI：[−0.11，0.1]）。鞘内注射咪达唑仑还可将感觉和运动阻滞发生时间缩短到小于1 min，并延长感觉阻滞持续时间，但对运动阻滞持续时间没有显著影响。
结论：目前的证据表明，鞘内注射咪达唑仑作为腰麻的辅助药物，可以提供适度的镇痛和显著的止吐作用，但会导致剖宫产患者出现更多的镇静相关不良事件。鞘内注射咪达唑仑对新生儿Apgar评分无影响。然而，未来应对新生儿安全、产妇神经影响进行更为客观、敏感和长期的测量。
原始文献来源：Tsung-Yu Hung，Yin-Shan Huang, Ying-Chun Lin,et al.Maternal and neonatal outcomes with the addition of intrathecal midazolam as an adjuvant to spinal anesthesia in cesarean delivery: A systematic review and meta-analysis of randomized controlled trials [J]. (J Clin Anesth 2022 09;80).
Maternal and neonatal outcomes with the addition of intrathecal midazolam as an adjuvant to spinal anesthesia in cesarean delivery: A systematic review and meta-analysis of randomized controlled trials
Study objective: To determine the efficacy and safety, in terms of maternal and neonatal outcomes, of adding intrathecal midazolam to spinal anesthesia for cesarean delivery in healthy pregnant women.
Design: A meta-analysis of randomized controlled trials was conducted. PubMed, Cochrane Library, Embase, and Web of Science were searched manually, and citation screening was completed on May 20, 2021.
Setting: Most of the included data were collected in the operating room and postoperative recovery area.
Patients: A total of 1382 healthy parturients undergoing cesarean delivery with single-shot spinal anesthesia were recruited in 19 eligible randomized controlled trials.
Interventions: Single intrathecal midazolam adjuvant was compared to a control, with the local anesthetic dose in spinal anesthesia identical between the intervention and control groups.
Measurements: The primary outcomes were time to first analgesic use, maternal adverse effects, and neonatal Apgar scores at 1 and 5 min. The secondary outcomes were the onset and duration of the sensory and motor blocks.
Main results: Adjuvant intrathecal midazolam prolonged the time to the first analgesic (mean difference [MD]: 59.96 min, 95% confidence interval [CI]: [23.12, 96.79]) and decreased perioperative maternal nausea and/or vomiting (odds ratio [OR], 0.28; 95% CI: [0.17, 0.45]). However, more sedation events were observed with midazolam (OR, 3.93; 95% CI: [1.12, 13.78]). There was no significant difference in the neonatal Apgar scores at 1 or 5 min (MD: -0.29, 95% CI: [−0.61, 0.03]; MD: -0.00, 95% CI: [−0.11, 0.1], respectively). Intrathecal midazolam also shortened sensory and motor block onset by less than 1 min and prolonged sensory block duration but had no significant effect on motor block duration.
Conclusions: Current evidence indicates that intrathecal midazolam, as an adjuvant to spinal anesthesia, provides modest analgesic and significant antiemetic effects at the cost of more sedation events in cesarean delivery patients. The neonatal Apgar score was not affected by intrathecal midazolam administration. However, more objective, sensitive, and long-term measurements of neonatal safety and maternal neurological effects should be performed in the future.
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