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确定瑞米唑仑预防人工流产术中体动的90%有效剂量:一项偏倚硬币上下顺序分配试验

Determining the 90% Effective Dose of Remimazolam to Prevent Physical Movement in Surgical Abortions: A Biased-Coin Up-and-Down Sequential Allocation Trial.

作者信息

Fang Fuquan, Li Huiling, Li Lei, Yan Bing, Yin Pengfei, Hu Binwei, Zhu Shengmei, Kang Xianhui

机构信息

Department of Anesthesiology, The First Affiliated Hospital, Zhejiang University School of Medicine, Hangzhou, Zhejiang, People's Republic of China.

Department of Anesthesiology, The First Affiliated Hospital of Zhejiang University of Medicine, Haining Branch, Haining, Zhejiang, People's Republic of China.

出版信息

Drug Des Devel Ther. 2025 Jul 29;19:6379-6389. doi: 10.2147/DDDT.S492245. eCollection 2025.

Abstract

BACKGROUND

Remimazolam is widely employed in surgical abortions. However, its dosing references from clinical studies such as gastrointestinal and bronchoscopic anesthesia have resulted in high incidence of physical movement.

PURPOSE

Determining the optimal dosage (the 90% effective dose [ED90]) for preventing physical movement during surgical abortions.

PATIENTS AND METHODS

Fifty-seven individuals aged 18 to 45 undergoing surgical abortion were included. Remimazolam, combined with remifentanil, was utilized for anesthesia induction. Commencing at an initial dose of 0.25 mg/kg of remimazolam, subsequent adjustments relied on the preceding patient's response, employing an up-down sequential allocation utilizing a biased-coin design.

RESULTS

Patients received remimazolam doses ranging from 0.25 to 0.65 mg/kg. The estimated ED90, along with its 95% confidence interval (CI), for preventing physical movement was 0.615 mg/kg (0.398-0.629 mg/kg). Patients maintained stable circulation, and no significant adverse events were recorded. Patients reported a satisfaction score of 4.63 ± 0.62 points. Anesthesiologists rated their satisfaction at 4.19 ± 0.61 points, and endoscopists expressed a satisfaction level of 4.53 ± 0.57 points (based on a full score of 5 points, with a minimum of 1 point).

CONCLUSION

The ED90 of remimazolam during surgical abortion to prevent physical movement was determined to be 0.615 mg/kg (95% CI, 0.398-0.629 mg/kg).

摘要

背景

瑞马唑仑广泛应用于人工流产手术。然而,其在胃肠和支气管镜麻醉等临床研究中的给药参考导致身体运动发生率较高。

目的

确定人工流产手术中预防身体运动的最佳剂量(90%有效剂量[ED90])。

患者和方法

纳入57例年龄在18至45岁接受人工流产手术的个体。瑞马唑仑联合瑞芬太尼用于麻醉诱导。从初始剂量0.25mg/kg的瑞马唑仑开始,后续调整依赖于前一位患者的反应,采用偏倚硬币设计的上下序贯分配法。

结果

患者接受的瑞马唑仑剂量范围为0.25至0.65mg/kg。预防身体运动的估计ED90及其95%置信区间(CI)为0.615mg/kg(0.398 - 0.629mg/kg)。患者循环稳定,未记录到明显不良事件。患者报告的满意度评分为4.63±0.62分。麻醉医生的满意度评分为4.19±0.61分,内镜医生的满意度评分为4.53±0.57分(满分5分,最低1分)。

结论

人工流产手术中瑞马唑仑预防身体运动的ED90确定为0.615mg/kg(95%CI,0.398 - 0.629mg/kg)。

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