School of Anaesthesiology, Shandong Second Medical University, Weifang, Shandong, China.
Department of Anaesthesiology, Zibo Maternal and Child Health Hospital, Zibo, Shandong, China.
BMJ Open. 2024 Nov 14;14(11):e085519. doi: 10.1136/bmjopen-2024-085519.
Maintaining haemodynamic stability is crucial but challenging during the induction and maintenance of general anaesthesia (GA) in patients undergoing off-pump coronary artery bypass grafting (OPCABG). Remimazolam tosylate is a novel ultra-short-acting benzodiazepine with minimal cardiovascular depression. Currently, non-inferior studies comparing the haemodynamic changes induced by remimazolam and etomidate are limited. This study aims to assess the efficacy and safety of remimazolam tosylate for the induction and maintenance of GA in patients undergoing OPCABG.
This two-armed non-inferiority randomised controlled trial will include 88 patients aged 18-75 years who are scheduled for OPCABG. Patients will be randomly assigned in a 1:1 ratio to receive either remimazolam tosylate or etomidate and propofol for anaesthesia induction and maintenance. The primary outcome will be the fluctuation of mean artery pressure during anaesthesia induction. Secondary outcomes will include adverse events, adverse drug reactions, the cumulative dosage of vasoactive drugs, vital signs and bispectral index values at different time points, lengths of postoperative mechanical ventilation and tracheal intubation, lengths of intensive care unit stay and hospital stay and hospital mortality. Analyses will be conducted using both the intention-to-treat approach and the per-protocol approach.
This study was approved by the Ethics Committee of Zibo Central Hospital (No. 2024001). The trial results will be submitted to an international peer-reviewed journal.
ChiCTR.gov.cn: ChiCTR2400079615.
在非体外循环冠状动脉旁路移植术（OPCABG）患者中进行全身麻醉（GA）的诱导和维持期间，维持血流动力学稳定至关重要，但极具挑战性。甲苯磺酸雷米唑仑是一种新型的超短效苯二氮䓬类药物，对心血管系统的抑制作用最小。目前，比较雷米唑仑和依托咪酯诱导的血流动力学变化的非劣效性研究有限。本研究旨在评估甲苯磺酸雷米唑仑在 OPCABG 患者 GA 诱导和维持中的疗效和安全性。
这是一项两臂非劣效性随机对照试验，将纳入 88 名年龄在 18-75 岁之间、计划接受 OPCABG 的患者。患者将以 1:1 的比例随机分配接受甲苯磺酸雷米唑仑或依托咪酯和丙泊酚进行麻醉诱导和维持。主要结局将是麻醉诱导期间平均动脉压的波动。次要结局将包括不良事件、药物不良反应、血管活性药物的累积剂量、不同时间点的生命体征和双频谱指数值、术后机械通气和气管插管时间、重症监护病房和住院时间以及住院死亡率。分析将同时使用意向治疗和方案治疗方法进行。
本研究已获得淄博市中心医院伦理委员会的批准（编号：2024001）。试验结果将提交给国际同行评议期刊。
ChiCTR2400079615。
