Gao Shenqiang, Wang Tingting, Cao Li, Li Linyan, Yang Shengqiang
Department of Anesthesiology, Taian City Central Hospital, Taishan District, No.29, Longtan Road, Taian, 271000, Shandong Province, China.
Department of Anesthesiology, Shandong First Medical University, Taian, 271016, Shandong Province, China.
Int J Clin Pharm. 2023 Feb;45(1):137-145. doi: 10.1007/s11096-022-01487-4. Epub 2022 Nov 8.
Remimazolam and dexmedetomidine are commonly used as sedatives. However, the effects and safety of remimazolam alone or in combination with dexmedetomidine have not been investigated.
We sought to investigate the clinical effects of remimazolam alone or in combination with dexmedetomidine in bronchoscopy, and their influence on cognitive function.
Ninety eligible patients who underwent bronchoscopy under intravenous anesthesia were randomly divided into three groups: propofol control, remimazolam, and remimazolam plus dexmedetomidine. The primary outcome was the incidence of perioperative hypoxemia. Secondary outcomes included induction and maintenance doses of remimazolam, hemodynamic variables, scores for modified Observer's Assessment of Alertness/Sedation (MOAA/S), coughing, limb movement, incidence of adverse events, patient satisfaction, bronchoscopist satisfaction, incidence of post-operative cognitive dysfunction (POCD), time to loss of consciousness (LoC), and time to awake.
The incidence of hypoxemia, hypotension, and bronchoscopist satisfaction score were significantly decreased, and time to LoC and time to awake were markedly longer in the remimazolam and remimazolam plus dexmedetomidine groups than in the propofol control group (p < 0.05). The remimazolam group had significantly decreased induction and maintenance doses of remimazolam and a shorter time to LoC than the remimazolam plus dexmedetomidine group (p < 0.05). Scores for coughing, limb movement, MOAA/S, and post-operative patient satisfaction were comparable among the three groups. POCD was not induced in any of the groups.
Remimazolam is safe and effective for painless bronchoscopy, with a low incidence of adverse reactions, and exhibits a good synergistic effect with dexmedetomidine.
This trial protocol had been registered on Chinese Clinical Trial Registry (ChiCTR2000041435, date: 2020 12 26.
瑞马唑仑和右美托咪定常用作镇静剂。然而，单独使用瑞马唑仑或与右美托咪定联合使用的效果和安全性尚未得到研究。
我们试图研究单独使用瑞马唑仑或与右美托咪定联合使用在支气管镜检查中的临床效果及其对认知功能的影响。
90例在静脉麻醉下接受支气管镜检查的符合条件的患者被随机分为三组：丙泊酚对照组、瑞马唑仑组和瑞马唑仑加右美托咪定组。主要结局是围手术期低氧血症的发生率。次要结局包括瑞马唑仑的诱导和维持剂量、血流动力学变量、改良的观察者警觉/镇静评估（MOAA/S）评分、咳嗽、肢体运动、不良事件发生率、患者满意度、支气管镜检查医生满意度、术后认知功能障碍（POCD）发生率、意识消失时间（LoC）和苏醒时间。
瑞马唑仑组和瑞马唑仑加右美托咪定组的低氧血症、低血压发生率和支气管镜检查医生满意度评分显著降低，意识消失时间和苏醒时间明显长于丙泊酚对照组（p<0.05）。瑞马唑仑组的瑞马唑仑诱导和维持剂量显著降低，意识消失时间比瑞马唑仑加右美托咪定组短（p<0.05）。三组间咳嗽、肢体运动、MOAA/S评分和术后患者满意度相当。三组均未诱发POCD。
瑞马唑仑用于无痛支气管镜检查安全有效，不良反应发生率低，与右美托咪定具有良好的协同作用。
本试验方案已在中国临床试验注册中心注册（ChiCTR2000041435，日期：2020年12月26日）
