Min Jeong-Jin, Oh Eun Jung, Hwang Hyun Ji, Jo Sungwoo, Cho Hyunsung, Kim Chungsu, Lee Jong-Hwan
Department of Anesthesiology and Pain Medicine, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Korea.
Department of Anesthesiology and Pain Medicine, Kangbuk Samsung Hospital, Sungkyunkwan University School of Medicine, Seoul, Korea
Korean J Anesthesiol. 2025 Apr;78(2):139-147. doi: 10.4097/kja.24537. Epub 2025 Jan 3.
Remimazolam is a novel ultra-short-acting benzodiazepine known for its hemodynamic stability over propofol. However, its hemodynamic effects compared to those of etomidate are not well established. This study aimed to determine whether the use of remimazolam is non-inferior to etomidate with regard to the occurrence of post-induction hypotension in patients undergoing coronary artery bypass grafting.
Patients were randomly assigned to either the remimazolam group (6 mg/kg/h) or the etomidate group (0.3 mg/kg) for induction of anesthesia. Anesthetic depth was adjusted based on the bispectral index. Primary outcome was the incidence of post-induction hypotension, defined as a mean arterial pressure less than 65 mmHg within 15 min after endotracheal intubation, with a non-inferiority margin of 12%.
A total of 144 patients were finally analyzed. Incidence of post-induction hypotension was 36/71 (50.7%) in the remimazolam group and 25/73 (34.2%) in the etomidate group, with a rate difference of 16.5% (95% CI [3.0-32.6]) between the two groups that was beyond the prespecified non-inferiority margin of 12.0%. The number of patients who needed vasopressors was similar in the two groups.
In this non-inferiority trial, remimazolam failed to show non-inferiority to etomidate in terms of post-induction hypotension when used as an induction drug for general anesthesia in patients undergoing coronary artery bypass grafting. However, different doses or infusion techniques of remimazolam should be compared with etomidate in various patient groups to fully assess its hemodynamic non-inferiority during induction of anesthesia.
瑞马唑仑是一种新型超短效苯二氮䓬类药物，以其相对于丙泊酚的血流动力学稳定性而闻名。然而，与依托咪酯相比，其血流动力学效应尚未明确。本研究旨在确定在接受冠状动脉搭桥术的患者中，使用瑞马唑仑诱导后低血压的发生率是否不劣于依托咪酯。
将患者随机分为瑞马唑仑组（6mg/kg/h）或依托咪酯组（0.3mg/kg）进行麻醉诱导。根据脑电双频指数调整麻醉深度。主要结局是诱导后低血压的发生率，定义为气管插管后15分钟内平均动脉压低于65mmHg，非劣效界值为12%。
最终共分析了144例患者。瑞马唑仑组诱导后低血压的发生率为36/71（50.7%），依托咪酯组为25/73（34.2%），两组之间的率差为16.5%（95%CI[3.0 - 32.6]），超出了预先设定的12.0%的非劣效界值。两组中需要血管升压药的患者数量相似。
在这项非劣效性试验中，当瑞马唑仑作为冠状动脉搭桥术患者全身麻醉的诱导药物时，在诱导后低血压方面未能显示出不劣于依托咪酯。然而，应在不同患者群体中将瑞马唑仑的不同剂量或输注技术与依托咪酯进行比较，以全面评估其在麻醉诱导期间的血流动力学非劣效性。
