Department of Anesthesiology, Chengbei Branch of Hangzhou First People's Hospital (Hangzhou Geriatric Hospital), Hangzhou, 310000, China.
Department of Anesthesiology, Affiliated Hangzhou First People's Hospital, School of Medicine, Westlake University, Hangzhou, 310000, China.
BMC Anesthesiol. 2024 Jul 25;24(1):252. doi: 10.1186/s12871-024-02644-0.
The main sedative which is propofol in painless gastroenteroscopy, has a high risk of reducing blood pressure and respiratory depression. Remimazolam (a short-acting benzodiazepine) is expected to be widely used in painless gastroenteroscopy due to its rapid onset, rapid metabolism and light respiratory and circulation inhibition.
A randomized, single-blind, parallel, controlled study, 123 outpatients who were undergoing painless colonoscopy and ramdomly divided into group A, B and C, in Hangzhou First People's Hospital, July-December 2021. All patients were intravenously injected with 5 µg sufentanil for analgesic preconditioning. The group A was induced by 0.2 mg/kg remimazolam besylate. The group B was induced by 0.25 mg/kg remimazolam besylate. And the group C was inducted by 2.0 mg /kg propofol. If the patients had limb movement or MOAA/S score > 3 and so on, remimazolam besylate was added at 2.5 mg/ time in group A and B, and propofol emulsion injection was added at 0.5 mg/kg/ time in group C. During the operation, according to the actual situation, remimazolam was per added 2.5 mg in the experimental group, and propofol was 0.5 mg/kg in the control group. Heart rate (HR), non-invasive blood pressure (BP), respiratory rate (RR), pulse oxygen saturation (SpO), and improved vigilance/sedation score (MOAA/S) of patients was recorded from entering endoscopy room to get out of the anesthesia recovery room, also including perioperative adverse events, other medications or treatments, the time of patients waking up and leaving the hospital.
The successful rate of induction in three groups was 100%. There was no significant difference in the sedation completion rate among the three groups (Group A:90.2%, Group B: 92.7%, Group C: 92.7%, P = 1.000). The rate of adverse events after administration: group A(27.0%) and B(36.8%) both lower than group C(71.0%),P < 0.001;There was no significant difference between group A and group B, P > 0.744;The average time from the last drug administration to meet the discharge criteria of the subjects in three groups was as follows: The average time of group A(16.2 min) and Group B(16.5 min) both shorter than group C(19.6 min), P = 0.001; There was no significant difference between group A and group B, P = 0.742.
This study revealed that remimazolam is a safe and effective medication for colonoscopy sedation, the security of remimazolam is better than propofol, and the sedative effect with the initial dose of 0.25 mg/kg of remimazolam is optimal.
China Clinical Trial Center with registration number: 2100052615,02/11/2021.
无痛胃肠镜检查中主要的镇静剂是异丙酚，它有降低血压和呼吸抑制的高风险。雷米唑仑（一种短效苯二氮䓬类药物）有望因其起效迅速、代谢迅速以及对呼吸和循环的抑制作用较轻而在无痛胃肠镜检查中广泛应用。
这是一项在杭州市第一人民医院进行的随机、单盲、平行、对照研究，纳入了 2021 年 7 月至 12 月期间接受无痛结肠镜检查的 123 例门诊患者，并随机分为 A、B 和 C 组。所有患者均静脉注射 5μg舒芬太尼进行镇痛预处理。A 组以 0.2mg/kg 盐酸雷米唑仑诱导。B 组以 0.25mg/kg 盐酸雷米唑仑诱导。C 组以 2.0mg/kg 丙泊酚诱导。如果患者有肢体运动或 MOAA/S 评分>3 等情况，A 组和 B 组中雷米唑仑的添加剂量为 2.5mg/次，C 组中添加丙泊酚乳剂 0.5mg/kg/次。在手术过程中，根据实际情况，实验组中每次添加 2.5mg 雷米唑仑，对照组中添加 0.5mg/kg 丙泊酚。记录患者从进入内镜室到离开麻醉恢复室的心率（HR）、无创血压（BP）、呼吸频率（RR）、脉搏血氧饱和度（SpO）和改良警觉/镇静评分（MOAA/S），还包括围手术期不良事件、其他药物或治疗、患者清醒和出院时间。
三组的诱导成功率均为 100%。三组的镇静完成率无显著差异（A 组：90.2%，B 组：92.7%，C 组：92.7%，P=1.000）。用药后不良事件发生率：A 组（27.0%）和 B 组（36.8%）均低于 C 组（71.0%），P<0.001；A 组与 B 组无显著差异，P>0.744；三组中最后一次给药至符合受试者出院标准的平均时间如下：A 组（16.2 分钟）和 B 组（16.5 分钟）的平均时间均短于 C 组（19.6 分钟），P=0.001；A 组与 B 组无显著差异，P=0.742。
本研究表明雷米唑仑是一种安全有效的结肠镜镇静药物，其安全性优于丙泊酚，且初始剂量为 0.25mg/kg 的雷米唑仑具有最佳的镇静效果。
中国临床试验注册中心，注册号：2100052615，2021 年 2 月 11 日。
