Komatsu Shuichiro, Isogai Toshiaki, Makito Kanako, Matsui Hiroki, Fushimi Kiyohide, Yasunaga Hideo
Department of Clinical Epidemiology and Health Economics, School of Public Health, Graduate School of Medicine, The University of Tokyo, Tokyo, Japan.
Department of Clinical Epidemiology and Health Economics, School of Public Health, Graduate School of Medicine, The University of Tokyo, Tokyo, Japan; Department of Cardiology, Tokyo Metropolitan Tama Medical Centre, Tokyo, Japan.
Br J Anaesth. 2025 Apr;134(4):1050-1057. doi: 10.1016/j.bja.2024.11.046. Epub 2025 Feb 6.
Remimazolam is a novel anaesthetic and sedative agent that offers several advantages, including minimal adverse haemodynamic effects and availability of a specific antidote, flumazenil. Flumazenil can induce seizures as an adverse effect; however, the incidence of seizures after flumazenil reversal after total intravenous anaesthesia with remimazolam (remimazolam-flumazenil) remains unknown. We compared the risk of seizures between total i.v. anaesthesia with remimazolam-flumazenil or propofol.
We retrospectively identified patients who underwent elective surgery (excluding brain surgery) with total i.v. anaesthesia in Japan between April 2020 and March 2022 using the Japanese Diagnosis Procedure Combination database. Patients were divided into remimazolam-flumazenil and propofol groups. Patients in the remimazolam-flumazenil group were matched to those in the propofol group at a variable ratio of 1:3 (maximum) based on age, sex, hospital, and type of surgery. We conducted conditional logistic regression analyses to assess the association between total i.v. anaesthesia with remimazolam-flumazenil and the incidence of perioperative seizures.
We identified 12 033 patients who underwent total i.v. anaesthesia with remimazolam-flumazenil and 432 275 patients with propofol, creating a matched cohort of 19 105. The crude incidence of seizures was 0.66% (95% confidence interval, 0.63-0.68%). There was no significant difference in seizures between the two groups (adjusted odds ratio, 1.08; 95% confidence interval, 0.49-2.37).
We observed no significant differences in perioperative seizures between remimazolam-flumazenil and propofol in patients undergoing non-neurological surgery. This suggests that remimazolam-flumazenil is a possible alternative to total i.v. anaesthesia with propofol.
瑞马唑仑是一种新型麻醉和镇静剂，具有多种优势，包括对血流动力学的不良影响极小以及有特异性解毒剂氟马西尼。氟马西尼可诱发癫痫发作作为不良反应；然而，瑞马唑仑全静脉麻醉（瑞马唑仑 - 氟马西尼）后氟马西尼逆转后癫痫发作的发生率仍不清楚。我们比较了瑞马唑仑 - 氟马西尼全静脉麻醉与丙泊酚全静脉麻醉之间癫痫发作的风险。
我们使用日本诊断程序组合数据库，回顾性识别了2020年4月至2022年3月期间在日本接受择期手术（不包括脑外科手术）并采用全静脉麻醉的患者。患者分为瑞马唑仑 - 氟马西尼组和丙泊酚组。瑞马唑仑 - 氟马西尼组的患者根据年龄、性别、医院和手术类型以最大1:3的可变比例与丙泊酚组的患者进行匹配。我们进行了条件逻辑回归分析，以评估瑞马唑仑 - 氟马西尼全静脉麻醉与围手术期癫痫发作发生率之间的关联。
我们识别出12033例接受瑞马唑仑 - 氟马西尼全静脉麻醉的患者和432275例接受丙泊酚麻醉的患者，形成了一个19105例的匹配队列。癫痫发作的粗发生率为0.66%（95%置信区间，0.63 - 0.68%）。两组之间癫痫发作无显著差异（调整后的优势比，1.08；95%置信区间，0.49 - 2.37）。
我们观察到在接受非神经外科手术的患者中，瑞马唑仑 - 氟马西尼和丙泊酚在围手术期癫痫发作方面无显著差异。这表明瑞马唑仑 - 氟马西尼可能是丙泊酚全静脉麻醉的一种替代方法。
