Department of Anesthesiology, Beijing Friendship Hospital, Capital Medical University, Beijing, China (mainland).
Department of Anesthesiology, Beijing YouAn Hospital, Capital Medical University, Beijing, China (mainland).
Med Sci Monit. 2022 Jun 16;28:e936580. doi: 10.12659/MSM.936580.
BACKGROUND This prospective, randomized, controlled study evaluated the efficacy and safety of remimazolam tosilate sedation with adjuvant sufentanil, relative to propofol, for Chinese patients with liver cirrhosis undergoing gastroscopy. MATERIAL AND METHODS Patients with liver cirrhosis (n=148) aged 18-65 years and undergoing gastroscopy were randomly and equally allocated to receive either 0.107 mg/kg remimazolam tosilate (remimazolam group) or 2 mg/kg propofol. Patients received intravenous sufentanil 0.15 μg/kg before the study drug. If necessary, an additional dose of propofol 20 mg was used and repeated. The primary outcome was the satisfaction rating (satisfactory, fair, or unsatisfactory) of the endoscopist with the sedation. Secondary outcomes were complications (respiratory depression, apnea, body movement, bradycardia, hypotension, nausea or vomiting, somnolence, dizziness, and fever) and patient satisfaction. RESULTS Compared with the propofol group, the remimazolam group required a longer time to sedation and a shorter time to emergence. The percentage of remimazolam sedations the endoscopist rated satisfactory (90.5%) was higher than that for propofol (77.0%; P=0.026). Patients given remimazolam experienced lower rates of respiratory depression, body movement, and hypotension (2.7, 8.1, 4.1%, respectively), than did the propofol group (17.6, 23.0, 14.9%; P=0.003, 0.013, 0.025). The 2 groups were comparable regarding the other secondary outcomes. CONCLUSIONS For Chinese patients with liver cirrhosis undergoing gastroscopy, remimazolam tosilate with adjuvant sufentanil provides a satisfactory level of sedation with a good safety profile.
本前瞻性、随机、对照研究评估了甲苯磺酸雷米唑仑联合舒芬太尼辅助镇静相对于丙泊酚在接受胃镜检查的中国肝硬化患者中的疗效和安全性。
将 148 例年龄 18-65 岁的肝硬化患者随机分为两组，每组 74 例，分别接受 0.107mg/kg 甲苯磺酸雷米唑仑（雷米唑仑组）或 2mg/kg 丙泊酚。所有患者在研究药物前均给予舒芬太尼 0.15μg/kg。如果需要，可重复给予 20mg 丙泊酚。主要结局是内镜医师对镇静的满意度评分（满意、一般或不满意）。次要结局是并发症（呼吸抑制、呼吸暂停、躯体运动、心动过缓、低血压、恶心或呕吐、嗜睡、头晕和发热）和患者满意度。
与丙泊酚组相比，雷米唑仑组镇静时间更长，苏醒时间更短。内镜医师评定雷米唑仑镇静满意度（90.5%）高于丙泊酚组（77.0%；P=0.026）。给予雷米唑仑的患者呼吸抑制、躯体运动和低血压的发生率（分别为 2.7%、8.1%和 4.1%）低于丙泊酚组（17.6%、23.0%和 14.9%；P=0.003、0.013 和 0.025）。两组其他次要结局相当。
对于接受胃镜检查的中国肝硬化患者，甲苯磺酸雷米唑仑联合舒芬太尼辅助镇静可提供满意的镇静效果，且安全性良好。
