Tian Youli, Li Jintong, Jin Minggen, Piao YiHua, Sheng Jisheng, Mei Zhixiong, Cui Qingsong, Li Lilin
Department of Intensive Care Unit, Yanbian University Hospital, No. 1327, Juzi Street, Xinxing Street, Yanji, 136200, Jilin, China.
Department of Intensive Care Unit, Linyi People's Hospital, Shandong, 276000, China.
Ann Intensive Care. 2025 Jan 14;15(1):8. doi: 10.1186/s13613-025-01431-5.
Invasive procedures and environmental factors in the intensive care unit (ICU) may cause anxiety and discomfort in patients, who often require sedation therapy. The aim of this study was to assess the safety of remimazolam tosilate for procedural sedation in ICU patients receiving mechanical ventilation following endotracheal intubation. Eighty patients from a single centre were randomly assigned to either the propofol group or the remimazolam group. Blood tests were conducted to evaluate changes in lactate, blood lipids, liver and kidney function, and inflammatory markers, and patients' vital signs were observed over several periods. This study compared the incidence of delirium, the impact on liver and kidney function, circulatory effects, and changes in blood lipids between the two groups. These findings have optimised the selection of medications, providing ICU patients with more options for sedation therapy.
In this single-centre randomised controlled trial, intubated patients were randomly assigned to the remimazolam group or the propofol group. Under the same analgesic regimen, the two groups received remimazolam and propofol for procedural sedation.
Our primary outcome was the mean arterial pressure (MAP), which significantly differed on Days 4 and 7 (P = 0.021, control group vs. experimental group = 85.23 ± 11.24 vs. 94.36 ± 13.18, P = 0.023, 83.55 ± 8.94 vs. 92.66 ± 7.02). With respect to liver and kidney function, the ∆AST value in the remimazolam group was significantly lower than that in the control group on Day 7 (P = 0.023). There were significant differences in triglyceride (TG) levels on Days 4 and 7 (P = 0.020) and in the ∆LDL on Day 7 (P = 0.027). Furthermore, the rates of dyslipidaemia and delirium in the remimazolam group were lower than those in the propofol group (85.0%, n = 40 vs. 90.0%, n = 40; 27.5%, n = 40 vs. 55%, n = 40).
Remimazolam is a novel benzodiazepine that has demonstrated promising applications in general anaesthesia and procedural sedation; however, its use in ICU sedation is still in the early stages of research. Current evidence suggests that remimazolam is a safe sedative that is particularly well suited for patients with haemodynamic instability. Large sample-size randomised clinical trials are warranted.
重症监护病房（ICU）中的侵入性操作和环境因素可能会导致患者焦虑和不适，这些患者通常需要镇静治疗。本研究的目的是评估在气管插管后接受机械通气的ICU患者中，使用甲苯磺酸瑞马唑仑进行程序性镇静的安全性。来自单一中心的80名患者被随机分配到丙泊酚组或瑞马唑仑组。进行血液检查以评估乳酸、血脂、肝肾功能和炎症标志物的变化，并在多个时间段观察患者的生命体征。本研究比较了两组之间谵妄的发生率、对肝肾功能的影响、循环效应以及血脂变化。这些发现优化了药物选择，为ICU患者提供了更多的镇静治疗选择。
在这项单中心随机对照试验中，将插管患者随机分配到瑞马唑仑组或丙泊酚组。在相同的镇痛方案下，两组分别接受瑞马唑仑和丙泊酚进行程序性镇静。
我们的主要结局指标是平均动脉压（MAP），在第4天和第7天有显著差异（P = 0.021，对照组与试验组分别为85.23±11.24 vs. 94.36±13.18，P = 0.023，83.55±8.94 vs. 92.66±7.02）。关于肝肾功能，瑞马唑仑组在第7天的∆AST值显著低于对照组（P = 0.023）。在第4天和第7天，甘油三酯（TG）水平以及第7天的∆低密度脂蛋白（LDL）存在显著差异（P = 0.020，P = 0.027）。此外，瑞马唑仑组的血脂异常和谵妄发生率低于丙泊酚组（85.0%，n = 40 vs. 90.0%，n = 40；27.5%，n = 40 vs. 55%，n = 40）。
瑞马唑仑是一种新型苯二氮䓬类药物，已在全身麻醉和程序性镇静中显示出有前景的应用；然而，其在ICU镇静中的应用仍处于研究初期。目前的证据表明，瑞马唑仑是一种安全的镇静剂，特别适合血流动力学不稳定的患者。有必要进行大样本量的随机临床试验。
