The aim of this study was to evaluate the efficacy and safety of remimazolam besylate compared with propofol in maintaining mild-to-moderate sedation in patients receiving long-term mechanical ventilation. In this single-centered randomized pilot study, adult patients mechanically ventilated longer than 24 h were randomized to receive remimazolam besylate or propofol. The target sedation range was − 3 to 0 on the Richmond Agitation and Sedation Scale (RASS). The primary outcome was the percentage of time in the target sedation range without rescue sedation. The secondary outcomes were ventilator-free days at day 7, the length of ICU stay and 28-day mortality. Thirty patients were assigned to each group. No difference was identified between the remimazolam group and propofol group in median age [60.0 (IQR, 51.5–66.3) years vs. 64.0 (IQR, 55.0–69.3) years, respectively, p = 0.437] or the median duration of study drug infusion [55.0 (IQR, 28.3–102.0) hours vs. 41.0 (IQR, 24.8–74.3) hours, respectively, p = 0.255]. The median percentage of time in the target RASS range without rescue sedation was similar in remimazolam and propofol groups [73.2% (IQR, 41.5–97.3%) vs. 82.8% (IQR, 65.6–100%), p = 0.269]. No differences were identified between the two groups in terms of ventilator-free days at day 7, length of ICU stay, 28-day mortality or adverse events. This pilot study suggested that remimazolam besylate was effective and safe for long-term sedation in mechanically ventilated patients compared with propofol.

中文翻译：

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苯磺酸瑞马唑仑与异丙酚在有创机械通气期间长期镇静的对比：一项初步研究


本研究的目的是评估苯磺酸瑞马唑仑与异丙酚相比，在接受长期机械通气的患者维持轻至中度镇静方面的有效性和安全性。在这项单中心随机试点研究中，机械通气时间超过 24 小时的成年患者被随机分配接受苯磺酸瑞马唑仑或异丙酚治疗。里士满激动和镇静量表 (RASS) 上的目标镇静范围为 - 3 至 0。主要结果是在目标镇静范围内不进行救援镇静的时间百分比。次要结局是第 7 天的无呼吸机天数、ICU 住院时间和 28 天死亡率。每组分配三十名患者。瑞马唑仑组和丙泊酚组的中位年龄[分别为 60.0 (IQR, 51.5–66.3) 岁 vs. 64.0 (IQR, 55.0–69.3) 岁，p = 0.437] 或研究药物输注的中位持续时间没有差异。 [分别为 55.0（IQR，28.3–102.0）小时与 41.0（IQR，24.8–74.3）小时，p = 0.255]。瑞马唑仑组和丙泊酚组中，未采用救援镇静的情况下处于目标 RASS 范围内的时间中位百分比相似 [73.2% (IQR, 41.5–97.3%) vs. 82.8% (IQR, 65.6–100%)，p = 0.269]。两组在第 7 天不使用呼吸机的天数、ICU 住院时间、28 天死亡率或不良事件方面没有差异。这项初步研究表明，与异丙酚相比，苯磺酸瑞马唑仑对于机械通气患者的长期镇静是有效且安全的。