Comparison of the efficacy and safety of remimazolam and propofol for fiberoptic bronchoscopy in older patients: a prospective, randomized controlled study.
Binggao Chai, Jiaxi Guo, Zhiwei Xu, Tao Chen, Hongquan Wang, Zhenqiang Zhu, Jian Zhong, Kanzheng Chen, Jianlong Du, Xianhui Kang
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Abstract
Objective: The aim of this study was to compare the efficacy and safety of remimazolam with those of propofol in older patients undergoing fiberoptic bronchoscopy with preserved spontaneous breathing.
Methods: Sixty older patients were randomly and equally divided into a remimazolam group (group R) and a propofol group (group P). Both groups received 0.15 µg/kg of sufentanil for analgesia. Group R received an initial dose of 0.2 mg/kg remimazolam and was injected with a maintenance dose of 1 mg/kg/h. Group P received an initial dose of 2 mg/kg propofol and was injected with a maintenance dose of 4 mg/kg/h. The primary evaluation indicators were the success rate of sedation and the incidence of hypotension. The secondary evaluation indicators were respiratory depression, hypertension, tachycardia, bradycardia, awakening time, quality of recovery-15 (QOR-15) score, patient satisfaction, physician satisfaction, and adverse events.
Results: Success rates of sedation were similar between group R (96.7%) and group P (100%). The incidence of hypotension in group R was lower than that in group P (2/30 vs. 10/30, p = 0.01). Respiratory depression was lower in group R than in group P (3/30 vs. 10/30, p = 0.03). Fewer patients reported injection pain in group R (0/30 vs. 7/30, p = 0.01). There were no significant differences in hypertension, tachycardia, bradycardia, awakening time, QoR-15 score, patient satisfaction, physician satisfaction, or adverse events between the two groups.
Conclusions: Remimazolam has a high sedation success rate for painless fiberoptic bronchoscopy in older patients, and the incidence of hypotension and respiratory depression is lower than that of propofol. Remimazolam may be a better choice for sedation during painless fiberoptic bronchoscopy in older patients with preserved spontaneous breathing.
目的：本研究的目的是比较雷马唑仑与异丙酚在保留自主呼吸的老年纤维支气管镜患者中的疗效和安全性。方法：60例老年患者随机平均分为雷马唑仑组（R组）和异丙酚组（P组）。两组均给予0.15µg/kg舒芬太尼镇痛。R组初始剂量为0.2 mg/kg雷马唑仑，维持剂量为1 mg/kg/h。P组初始剂量为2 mg/kg异丙酚，维持剂量为4 mg/kg/h。主要评价指标为镇静成功率和低血压发生率。次要评价指标为呼吸抑制、高血压、心动过速、心动过缓、苏醒时间、恢复质量-15 （QOR-15）评分、患者满意度、医师满意度、不良事件。结果：R组镇静成功率为96.7%，P组为100%。R组低血压发生率低于P组（2/30 vs 10/30, P = 0.01）。R组呼吸抑制低于P组（3/30比10/30，P = 0.03）。R组出现注射疼痛的患者较少（0/30 vs. 7/30, p = 0.01）。两组患者在高血压、心动过速、心动过缓、苏醒时间、QoR-15评分、患者满意度、医生满意度、不良事件等方面均无显著差异。结论：雷马唑仑对老年患者无痛纤维支气管镜镇静成功率高，低血压和呼吸抑制发生率低于异丙酚。雷马唑仑可能是保持自主呼吸的老年患者无痛纤维支气管镜检查时镇静的较好选择。试验注册：ChiCTR2300069041；6/3/2023。
期刊介绍：
BMC Geriatrics is an open access journal publishing original peer-reviewed research articles in all aspects of the health and healthcare of older people, including the effects of healthcare systems and policies. The journal also welcomes research focused on the aging process, including cellular, genetic, and physiological processes and cognitive modifications.
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