瑞马唑仑联合不同剂量布托啡诺用于孕早期人工流产的急诊处理
ED of remimazolam combined with different doses butorphanol for first trimester artificial abortion.
作者信息
Chen Jinming, Li Xiaoling, Hu Zilan, Zheng Yuling, Mai Ying, Zhang Zhongqi
机构信息
Department of Anesthesiology, The Affiliated Shunde Hospital of Jinan University, Foshan, China.
Department of Gynecology, The Affiliated Shunde Hospital of Jinan University, Foshan, China.
出版信息
Front Med (Lausanne). 2024 Apr 18;11:1385998. doi: 10.3389/fmed.2024.1385998. eCollection 2024.
INTRODUCTION
Remimazolam (RMZ) is a novel intravenous sedative drug of ultra-short benzodiazepine. The optimal dose of RMZ plus butorphanol for sedation during first trimester artificial abortion is unknown. Therefore, the present study aimed to evaluate the median effective dose (ED) of RMZ combined with different doses of butorphanol on the sedative effect for first-trimester artificial abortion.
METHODS
Sixty-one female patients were randomly assigned to Group B10 (31 patients) and Group B15 (30 patients). RMZ was administered 5 min after IV butorphanol at doses of 10 μg/kg (Group B10) and 15 μg/kg (Group B15). Cervical dilatation at the time of using a cervical dilating rod, if the patient has body movement and affects the gynecologist's operation, we define it as "Ineffective." Therefore, the dose of RMZ was increased in the next patient. Otherwise, it was defined as "Effective," and the dose of RMZ was reduced in the next patient. According to the pre-experiment, the first dose of RMZ in the first patient was 0.35 mg/kg, and the adjacent geometric dose ratio was 0.9. The centered isotonic regression was performed to determine the ED of RMZ. The total RMZ dose administered, recovery time, and anesthesia-related adverse events were all recorded.
RESULTS
The ED (90% CI) of RMZ was 0.263 (0.215-0.310) mg/kg in Group B10, and 0.224 (0.191-0.261) mg/kg in Group B15, respectively. The recovery time in Group B10 was significantly shorter than in Group B15 (9.8 ± 2.3 vs. 12.5 ± 3.6 min, ≤ 0.001). There was no significant difference in the incidence rate of all anesthesia-related adverse events between the two groups ( > 0.05).
CONCLUSION
The ED50 of RMZ combined with a 10 μg/kg or 15 μg/kg dose of butorphanol was 0.263 and 0.224 mg/kg during painless first trimester artificial abortion. However, RMZ combined with a 10 μg/kg dose of butorphanol seems to have a shorter recovery time.
CLINICAL TRIAL REGISTRATION
引言
瑞米唑仑（RMZ）是一种新型的超短效苯二氮䓬类静脉镇静药物。RMZ联合布托啡诺用于孕早期人工流产镇静的最佳剂量尚不清楚。因此，本研究旨在评估RMZ联合不同剂量布托啡诺用于孕早期人工流产镇静效果的半数有效剂量（ED）。
方法
61例女性患者被随机分为B10组（31例）和B15组（30例）。静脉注射布托啡诺后5分钟给予RMZ，剂量分别为10μg/kg（B10组）和15μg/kg（B15组）。使用宫颈扩张棒时的宫颈扩张情况，如果患者有身体移动并影响妇科医生操作，我们将其定义为“无效”。因此，下一位患者的RMZ剂量增加。否则，定义为“有效”，下一位患者的RMZ剂量减少。根据预实验，第一位患者的RMZ首剂为0.35mg/kg，相邻几何剂量比为0.9。采用中心等渗回归法确定RMZ的ED。记录RMZ的总给药剂量、恢复时间和麻醉相关不良事件。
结果
B10组RMZ的ED（90%CI）为0.263（0.215 - 0.310）mg/kg，B15组为0.224（0.191 - 0.261）mg/kg。B10组的恢复时间明显短于B15组（9.8±2.3 vs. 12.5±3.6分钟，P≤0.001）。两组所有麻醉相关不良事件的发生率无显著差异（P>0.05）。
结论
在无痛孕早期人工流产中，RMZ联合10μg/kg或15μg/kg剂量布托啡诺的ED50分别为0.263和0.224mg/kg。然而，RMZ联合10μg/kg剂量布托啡诺似乎恢复时间更短。
临床试验注册
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