SummaryIntroductionRemimazolam is an ultra‐short‐acting benzodiazepine sedative drug. This study aimed to compare the efficacy and safety of remimazolam with propofol for induction and maintenance of general anaesthesia in children undergoing elective surgery.MethodsChildren (aged 3–6 y, ASA physical status 1 or 2, BMI 14–25 kg.m‐2) undergoing elective surgery under general anaesthesia with tracheal intubation were eligible for inclusion. Children were allocated randomly using a web‐based system to receive either remimazolam or propofol in a 3:1 ratio. After receiving fentanyl 3 μg.kg‐1, children received their allocated drug for both induction and maintenance of general anaesthesia. Induction doses were remimazolam 0.3 mg.kg‐1 or propofol 2.5 mg.kg‐1, with a second dose given should they not achieve loss of consciousness. After neuromuscular blockade and tracheal intubation, maintenance anaesthesia was achieved with an infusion either remimazolam 1–3 mg.kg‐1.h‐1 or propofol 4–12 mg.kg‐1.h‐1, alongside a remifentanil infusion (0.1–0.5 μg.kg‐1.min‐1) titrated to surgical stimulus and haemodynamic parameters. Primary outcomes were the incidence of successful induction and maintenance of anaesthesia. Secondary outcomes included: time to loss of consciousness, awakening and tracheal extubation; incidence of emergence delirium and moderate or severe pain in post‐anaesthesia care unit; incidence of negative behaviour change after surgery at postoperative day 3; and incidence of adverse events.ResultsA total of 187 children were analysed (140 allocated to remimazolam and 47 to propofol). All children achieved successful induction of anaesthesia. Successful maintenance of anaesthesia was achieved in 139 (99%) children who received remimazolam compared with 46 (98%) who received propofol (rate difference 1.4%, 95%CI ‐2.9–5.8%, p = 0.441). Adverse events occurred in 27 (19%) children who received remimazolam and 23 (49%) who received propofol.DiscussionRemimazolam was well tolerated for the induction and maintenance of general anaesthesia in pre‐school‐age children and was non‐inferior to propofol.

中文翻译：

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甲苯磺酸瑞马唑仑对择期手术儿科患者全身麻醉的安全性和有效性：一项多中心、随机、单盲、对照试验


摘要介绍瑞马唑仑是一种超短效苯二氮卓类镇静药物。本研究旨在比较瑞马唑仑与异丙酚诱导和维持择期手术患儿全身麻醉的疗效和安全性。方法在全身麻醉下接受气管插管择期手术的儿童 （3-6 岁，ASA 身体状况 1 或 2，BMI 14-25 kg.m-2） 符合纳入条件。使用基于网络的系统随机分配儿童，以 3：1 的比例接受瑞马唑仑或异丙酚。在接受芬太尼 3 μ g.kg-1 后，儿童接受他们分配的药物，用于诱导和维持全身麻醉。诱导剂量为瑞马唑仑 0.3 mg.kg-1 或异丙酚 2.5 mg.kg-1，如果他们没有达到意识丧失，则给予第二剂。神经肌肉阻滞和气管插管后，通过输注瑞马唑仑 1-3 mg.kg-1.h-1 或异丙酚 4-12 mg.kg-1.h-1，同时输注瑞芬太尼 （0.1-0.5 μ g.kg-1.min-1） 实现维持麻醉根据手术刺激和血流动力学参数滴定。主要结局是成功诱导和维持麻醉的发生率。次要结局包括：意识丧失、觉醒和气管拔管的时间;麻醉后监护病房苏醒谵妄和中度或重度疼痛的发生率;术后第 3 天手术后消极行为改变的发生率;和不良事件的发生率。结果共分析了 187 名儿童 （140 名分配给瑞马唑仑，47 名分配给异丙酚）。所有患儿均成功诱导麻醉。 接受瑞马唑仑治疗的 139 名 （99%） 儿童成功维持麻醉，而接受异丙酚治疗的 46 名 （98%） 儿童成功维持麻醉 （率差 1.4%，95% CI -2.9-5.8%，p = 0.441）。27 例 （19%） 接受瑞马唑仑治疗的儿童和 23 例 （49%） 接受异丙酚治疗的儿童发生不良事件。讨论瑞马唑仑对学龄前儿童全身麻醉的诱导和维持耐受性良好，不劣于异丙酚。