手术结束时给予瑞马唑仑单次推注可减少接受扁桃体切除术和腺样体切除术儿童的苏醒期谵妄：一项随机、三盲、安慰剂对照试验。

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中文摘要

背景/目的： 苏醒期谵妄（ED）在接受耳鼻喉科手术的儿童中于七氟烷麻醉后常见。瑞马唑仑是一种超短效苯二氮䓬类药物，可能在不延迟恢复的情况下减少ED。本研究评估了手术结束时单次给予瑞马唑仑推注对接受扁桃体切除术和/或腺样体切除术儿童ED的影响。方法：在这项前瞻性、随机、三盲、安慰剂对照试验中，110名年龄3-9岁、美国麻醉医师协会身体状况分级为I级的儿童在停用七氟烷后立即、拔管前接受瑞马唑仑0.1 mg/kg（n = 57）或等体积生理盐水（n = 53）。主要结局为拔管时ED，定义为儿童麻醉苏醒期谵妄（PAED）评分≥ 10。次要结局包括面部、腿部、活动、哭泣和可安慰性（FLACC）评分、苏醒时间、早期恢复、术后呕吐和气道并发症。结果：接受瑞马唑仑的57名儿童中有1名（1.8%）发生ED，接受安慰剂的53名儿童中有11名（20.8%）发生ED（p = 0.002）。绝对风险降低为19.0%（95%置信区间[CI]，7.5-31.8），相对风险为0.08（95% CI，0.01-0.63），需治疗人数为6。拔管时FLACC评分的总体分布在两组间存在差异（p = 0.047），瑞马唑仑组FLACC评分为0的情况更常见。两组的中位苏醒时间均为10 min，所有儿童均在15 min内达到改良Aldrete评分> 8。术后呕吐评估至30 min；5 min时的比较显示组间无显著差异。气道并发症在两组间也无显著差异。结论：手术结束时单次静脉推注瑞马唑仑0.1 mg/kg可显著减少PAED定义的ED，且不延长苏醒时间或延迟术后早期恢复。

英文摘要

Background/Objectives: Emergence delirium (ED) is common after sevoflurane anesthesia in children undergoing otolaryngologic surgery. Remimazolam is an ultra-short-acting benzodiazepine that may reduce ED without delaying recovery. This study evaluated the effect of a single remimazolam bolus administered at the end of surgery on ED in children undergoing tonsillectomy and/or adenoidectomy. Methods: In this prospective, randomized, triple-blind, placebo-controlled trial, 110 children aged 3-9 years with American Society of Anesthesiologists physical status I received remimazolam 0.1 mg/kg (n = 57) or an equal volume of normal saline (n = 53) immediately after discontinuation of sevoflurane and before extubation. The primary outcome was ED at extubation, defined as a Pediatric Anesthesia Emergence Delirium (PAED) score ≥ 10. Secondary outcomes included Face, Legs, Activity, Cry, and Consolability (FLACC) scores, emergence time, early recovery, postoperative vomiting, and airway complications. Results: ED occurred in 1 of 57 children (1.8%) receiving remimazolam and in 11 of 53 children (20.8%) receiving placebo (p = 0.002). The absolute risk reduction was 19.0% (95% confidence interval [CI], 7.5-31.8), the relative risk was 0.08 (95% CI, 0.01-0.63), and the number needed to treat was 6. The overall distribution of FLACC scores at extubation differed between groups (p = 0.047), with FLACC scores of 0 occurring more frequently in the remimazolam group. Median emergence time was 10 min in both groups, and all children achieved a modified Aldrete score > 8 within 15 min. Postoperative vomiting was assessed through 30 min; the comparison at 5 min showed no significant between-group difference. Airway complications also did not differ significantly between groups. Conclusions: A single intravenous bolus of remimazolam 0.1 mg/kg administered at the end of surgery significantly reduced PAED-defined ED without prolonging emergence or delaying early postoperative recovery.