Department of Anesthesiology and Pain Medicine, Ajou University Medical Center, Ajou University School of Medicine, 164, World cup-ro, Yeongtong-gu, Suwon, 16499, Republic of Korea.
Department of Medical Sciences, Ajou University School of Medicine, 164, World cup-ro, Yeongtong-gu, Suwon, 16499, Republic of Korea.
BMC Anesthesiol. 2024 Aug 19;24(1):292. doi: 10.1186/s12871-024-02675-7.
This study aimed to determine the 50% effective dose of remimazolam co-administered with remifentanil for loss of consciousness in men and women as well as to investigate whether there are between-sex differences.
Using a modified Dixon's up-and-down allocation approach, we sequentially enrolled male and female patients aged 19-60 years with American Society of Anesthesiologists class I or II who were scheduled for robotic surgery. For both sexes, the starting remimazolam dose was 0.15 mg/kg, with a step size of 0.05 mg/kg. After achievement of a target effect-site concentration 2.0 ng/ml of remifentanil, and administration of a bolus dose of remimazolam, we assessed whether adequate loss of consciousness (defined as a Modified Observer's Assessment of Alertness/Sedation scale score < 2 within 2 min) was achieved.
We included 22 male and 22 female patients. Based on Dixon's up-and-down method, the 50% effective dose of remimazolam (mean ± standard error) was 0.13 ± 0.01 mg/kg and 0.17 ± 0.01 mg/kg in the male and female groups, respectively (P = 0.34). Isotonic regression analysis revealed that the 95% effective dose (95% confidence interval) was 0.19 (0.18-0.20) mg/kg in the male group and 0.29 (0.29-0.30) mg/kg in the female group.
There was no between-sex difference in the 50% effective dose of remimazolam for loss of consciousness; however, the 95% effective dose was significantly higher in female patients than in male patients.
This study protocol was registered at Clinical Research Information Service (CRIS No. KCT0007951, 02/12/2022).
本研究旨在确定男性和女性中咪达唑仑与瑞芬太尼联合应用致意识消失的半数有效剂量，并探讨是否存在性别差异。
采用改良 Dixon 序贯法，连续纳入年龄 19-60 岁、美国麻醉医师协会（ASA）分级Ⅰ或Ⅱ级、拟行机器人手术的男性和女性患者。起始咪达唑仑剂量为 0.15mg/kg，步长 0.05mg/kg。当达到瑞芬太尼效应室靶浓度 2.0ng/ml 并给予咪达唑仑推注后，评估是否达到足够的意识消失程度（定义为 2min 内改良观察者警觉/镇静评分<2）。
共纳入 22 例男性和 22 例女性患者。根据 Dixon 序贯法，男性和女性患者咪达唑仑的半数有效剂量（均数±标准误）分别为 0.13±0.01mg/kg 和 0.17±0.01mg/kg（P=0.34）。等比回归分析显示，男性组 95%有效剂量（95%置信区间）为 0.19（0.18-0.20）mg/kg，女性组为 0.29（0.29-0.30）mg/kg。
男性和女性患者咪达唑仑致意识消失的半数有效剂量无性别差异，但女性患者的 95%有效剂量显著高于男性患者。
本研究方案在临床研究信息服务处（CRIS 编号 KCT0007951，2022 年 02 月 12 日）注册。
