Liu Renhuai, Su Binxiao, Gan Guifen, Wang Guangming, Wang Chengli, Xu Ning, Feng Guangcai, Guo Hao, Yuan Qingxia, Li Aiguang, Zheng Wenping, Li Jiang, Chen Yu, Zhang Xijing
Department of Critical Care Medicine, Xijing Hospital, Fourth Military Medical University, Xi'an, Shaanxi, China.
Department of Critical Care Medicine, Affiliated Hospital of Qinghai University, Xining, China.
Front Med (Lausanne). 2025 Aug 26;12:1553495. doi: 10.3389/fmed.2025.1553495. eCollection 2025.
Previous studies have indicated that the administration of short-acting sedatives prior to weaning from mechanical ventilation is linked to a more rapid recovery and extubation process, in addition to lowering intensive care unit (ICU) treatment expenses. The present study aimed to evaluate the efficacy and safety of the sequential administration of remimazolam besylate compared with midazolam before weaning from mechanical ventilation.
This multicenter, randomized controlled trial was conducted across medical and surgical ICUs within a tertiary, academic medical center. The study population consisted of critically ill, mechanically ventilated adult patients. Candidates anticipated to be ready for ventilator weaning within 12 h underwent a Spontaneous Breathing Trial (SBT) safety screen. Only those who successfully passed this assessment were considered for inclusion in the final phase of the study and subsequent randomization. The patients were randomized into two groups: group M, in which the sedative regimen was transitioned to midazolam, and group R, which involved a switch to remimazolam. Sedative dosages were titrated to achieve a target Richmond Agitation-Sedation Scale (RASS) score between -3 and 0. The primary endpoint of this study was the time to extubation.
A total of 435 patients underwent screening, of whom 306 patients being randomized, and 272 patients ultimately included in the analysis, comprising 132 patients in group M and 140 patients in group R. The patients in group R maintained lighter levels of sedation compared to those in group M. The patients in group R showed significantly earlier recovery ( < 0.05) and extubation ( < 0.05) at the same RASS score prior to the cessation of sedatives. Higher prevalence of agitation was observed in group M as opposed to group R (20.45% versus 8.57%, = 0.005). However, no significant difference in the incidence of delirium was noted between the groups.
In critically ill, mechanically ventilated patients, the use of remimazolam besylate was associated with a shorter time to recovery and extubation prior to ventilator weaning, along with a lower incidence of agitation.
Identifier ChiCTR 2200065048, https://www.chictr.org.cn.
既往研究表明，在机械通气撤机前给予短效镇静剂，除了可降低重症监护病房（ICU）治疗费用外，还与更快的恢复和拔管过程相关。本研究旨在评估在机械通气撤机前，与咪达唑仑相比，序贯给予苯磺酸瑞马唑仑的疗效和安全性。
本多中心、随机对照试验在一家三级学术医疗中心的内科和外科ICU中进行。研究人群包括机械通气的成年危重症患者。预计在12小时内准备好进行呼吸机撤机的受试者接受了自主呼吸试验（SBT）安全筛查。只有成功通过该评估的受试者才被考虑纳入研究的最后阶段并随后进行随机分组。患者被随机分为两组：M组，镇静方案转换为咪达唑仑；R组，转换为苯磺酸瑞马唑仑。滴定镇静剂量以达到目标Richmond躁动 - 镇静量表（RASS）评分在-3至0之间。本研究的主要终点是拔管时间。
共有435例患者接受筛查，其中306例患者被随机分组，最终272例患者纳入分析，包括M组132例患者和R组140例患者。与M组患者相比，R组患者的镇静水平维持较轻。在相同的RASS评分下，R组患者在停用镇静剂前显示出明显更早的恢复（<0.05）和拔管（<0.05）。与R组相比，M组中躁动的发生率更高（20.45%对8.57%， =0.005）。然而，两组之间谵妄的发生率没有显著差异。
在机械通气的成年危重症患者中，使用苯磺酸瑞马唑仑与撤机前恢复和拔管时间缩短以及躁动发生率降低相关。
标识符ChiCTR 2200065048，https://www.chictr.org.cn。
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