芬太尼对接受宫腔镜手术的女性患者瑞马唑仑诱导镇静的影响：一项随机对照试验
Effect of Fentanyl on Remimazolam-Induced Sedation in Female Patients Undergoing Hysteroscopic Surgery: A Randomized Controlled Trial.
作者信息
Huang Xiao-Dong, Xu Lan, Zheng Cai-Hong, Chen Min-Min, Shou Hong-Yan, Zhou Zhen-Feng
机构信息
Department of Anesthesiology, Hangzhou Women's Hospital (Hangzhou Maternity and Child Health Care Hospital, Hangzhou First People's Hospital Qianjiang New City Campus, Zhejiang Chinese Medical University), Hangzhou, 310008, People's Republic of China.
Department of Anesthesiology, Affiliated Xiaoshan Hospital, Hangzhou Normal University, Hangzhou, 311202, People's Republic of China.
出版信息
Drug Des Devel Ther. 2025 Feb 27;19:1393-1401. doi: 10.2147/DDDT.S504189. eCollection 2025.
PURPOSE
Previous studies have reported the recommended dosage of remimazolam alone for achieving loss of consciousness (LoC). However, the effect of analgesics on the dosage of remimazolam for successful sedation remains unclear. This study evaluated the impact of fentanyl on the effective dose of remimazolam-induced sedation in female patients undergoing elective hysteroscopic surgery.
PATIENTS AND METHODS
Two hundred female patients were randomly allocated into two groups, receiving with or without fentanyl (1ug/kg) during anesthetic induction. Within each group, patients were randomized to receive one of four doses (0.1, 0.2, 0.3, and 0.4 mg/kg) of remimazolam for sedation. Modified Observer's Assessment of Alertness/Sedation (MOAA/S) was evaluated during anesthetic induction. Success was defined when the patient did not respond to painful trapezius squeeze and no requirement for rescue doses. Estimate of ED50 and ED95 with 95% confidence interval (CI) was performed by probit regression.
RESULTS
The ED50 and ED95 values of remimazolam for patients receiving fentanyl (1 ug/kg) were 0.097 (95% CI, 0.072-0.120) mg/kg and 0.254 (95% CI, 0.203-0.345) mg/kg, respectively. For patients not receiving fentanyl, the ED50 and ED95 values of remimazolam were 0.181 (95% CI, 0.149-0.215) mg/kg and 0.475 (95% CI, 0.377-0.687) mg/kg, respectively. The estimated relative median potency of remimazolam in patients, with and without fentanyl administration, was determined to be 0.534 (95% CI, 0.327-0.737).
CONCLUSION
The administration of fentanyl reduced the effective dose of remimazolam-induced sedation by 50% in female patients undergoing elective hysteroscopic surgery. The recommended ED95 dose for remimazolam-induced sedation was 0.254 mg/kg under the condition of this study.
TRIAL NUMBER AND REGISTRY URL
ChiCTR2400079842; https://www.chictr.org.cn/showproj.html?proj=216480: HUANG, Date of registration: January 15, 2024.
目的
以往研究报告了单独使用瑞马唑仑达到意识丧失（LoC）的推荐剂量。然而，镇痛药对瑞马唑仑成功镇静剂量的影响仍不清楚。本研究评估了芬太尼对择期宫腔镜手术女性患者瑞马唑仑诱导镇静有效剂量的影响。
患者与方法
200例女性患者随机分为两组，在麻醉诱导期间分别接受或不接受芬太尼（1μg/kg）。在每组中，患者随机接受四种剂量（0.1、0.2、0.3和0.4mg/kg）的瑞马唑仑之一进行镇静。在麻醉诱导期间评估改良的观察者警觉/镇静评估（MOAA/S）。当患者对疼痛的斜方肌挤压无反应且无需抢救剂量时定义为成功。通过概率回归进行ED50和ED95及其95%置信区间（CI）的估计。
结果
接受芬太尼（1μg/kg）患者的瑞马唑仑ED50和ED95值分别为0.097（95%CI，0.072 - 0.120）mg/kg和0.254（95%CI，0.203 - 0.345）mg/kg。未接受芬太尼的患者，瑞马唑仑的ED50和ED95值分别为0.181（95%CI，0.149 - 0.215）mg/kg和0.475（95%CI，0.377 - 0.687）mg/kg。接受和未接受芬太尼的患者中，瑞马唑仑的估计相对中位效价确定为0.534（95%CI，0.327 - 0.737）。
结论
在择期宫腔镜手术的女性患者中，芬太尼的使用使瑞马唑仑诱导镇静的有效剂量降低了50%。在本研究条件下，瑞马唑仑诱导镇静的推荐ED95剂量为0.254mg/kg。
试验编号和注册网址
ChiCTR2400079842；https://www.chictr.org.cn/showproj.html?proj=216480：黄，注册日期：2024年1月15日。
Zotero 插件