Yang Xiaobo, Tang Yun, Du Ruofei, Yu Yuan, Xu Jiqian, Zhang Jiancheng, Liu Hong, Zou Xiaojing, Ren Lehao, Yuan Shiying, Shang You
Department of Critical Care Medicine, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, Hubei, China.
Department of Biostatistics, University of Arkansa for Medical Sciences, Little Rock, AR, United States.
Front Pharmacol. 2023 Jul 28;14:1139872. doi: 10.3389/fphar.2023.1139872. eCollection 2023.
Remimazolam besylate is a novel ultra-short-acting benzodiazepine that can potentially be a safe and effective sedative in intensive care units. This study aims to assess whether remimazolam besylate is not inferior to propofol in maintaining mild-to-moderate sedation in critically ill patients receiving long-term mechanical ventilation. This is a multicenter, randomized, single-blind, propofol-controlled, non-inferiority study. Eligible patients are randomly assigned to receive remimazolam besylate or propofol in a 1:1 ratio to maintain a Richmond Agitation-Sedation Scale score between -3 and 0. When patients are under-sedated, rescue sedation of dexmedetomidine is added. The primary outcome is the percentage of time in the target sedation range. The secondary outcomes are hours free from the invasive ventilator in 7 days, successful extubation in 7 days, and weaning time, the length of intensive care unit stay, the length of hospital stay, and mortality in 28 days. Modified intention-to-treat and safety analysis is performed. https://clinicaltrials.gov/ct2/show/NCT05555667.
苯磺酸瑞马唑仑是一种新型超短效苯二氮䓬类药物，在重症监护病房有可能成为一种安全有效的镇静剂。本研究旨在评估在接受长期机械通气的危重症患者中，苯磺酸瑞马唑仑在维持轻至中度镇静方面是否不劣于丙泊酚。这是一项多中心、随机、单盲、丙泊酚对照的非劣效性研究。符合条件的患者按1:1的比例随机分配接受苯磺酸瑞马唑仑或丙泊酚治疗，以维持里士满躁动镇静量表评分在-3至0之间。当患者镇静不足时，加用右美托咪定进行挽救性镇静。主要结局是目标镇静范围内的时间百分比。次要结局包括7天内无创通气的时长、7天内成功拔管、撤机时间、重症监护病房住院时长、住院时长以及28天内的死亡率。进行改良意向性分析和安全性分析。https://clinicaltrials.gov/ct2/show/NCT05555667 。
