Lv Yuankai, Duan Gongchen, Wu Yini, Jiang Jianxin, You Minji, Wang Faxing, Wu Jimin, Dai Hong
Department of Respiratory Medicine, Lishui People's Hospital, China.
Department of Anesthesiology, Lishui People's Hospital, China.
J Int Med Res. 2025 Sep;53(9):3000605251372495. doi: 10.1177/03000605251372495. Epub 2025 Sep 8.
ObjectiveThe sedation protocol for flexible fiberoptic bronchoscopy has long been a matter of inconclusiveness. The aim of this study was to evaluate the safety and efficacy of remimazolam combined with alfentanil in flexible fiberoptic bronchoscopy and provide insights for optimizing clinical anesthesia strategies.MethodsThis study was a randomized, single-blind controlled trial. A total of 118 patients who underwent flexible fiberoptic bronchoscopy were randomized into two groups (59 patients per group). Both groups received intravenous alfentanil 10 µg/kg 2 min before sedation treatment, followed by either 0.2 mg/kg remimazolam (Group R) or 2 mg/kg propofol (Group P). During the flexible fiberoptic bronchoscopy, the experimental drugs were administered in patients in each group as needed to maintain the depth of sedation (modified observer's assessment of alertness/sedation score ≤ 3). The primary outcome was the incidence of hypoxemia. The secondary outcomes included other safety outcomes and effectiveness outcomes.ResultsA total of 115 participants completed the study. Compared with Group P, the incidence of severe hypoxemia in Group R was lower (3.4% vs. 15.8%, =0.029); the incidences of injection pain and hypotension in Group R were lower (10.3% vs. 33.3%, =0.003); and the incidences of hypotension, dizziness, and grade of cough in Group R were lower (<0.05). The sedation success rate and sedation success rate at an induced dose were similar between Groups R and P (0.05). Compared with Group P, sedation recovery time in Group R was shorter, and the operator comfort scores and patient comfort scores in Group R were higher (<0.05).ConclusionsRemimazolam, when combined with alfentanil, has shown excellent clinical potential in flexible fiberoptic bronchoscopy. Compared with propofol, it significantly reduced the incidence of severe hypoxemia, injection pain, hypotension, dizziness, and intraoperative coughing while maintaining comparable sedation success rates. It also shortened recovery time and improved both operator and patient comfort scores. These results support remimazolam plus alfentanil as a safe, effective, and well-tolerated alternative sedation regimen in this setting.
目的
长期以来，可弯曲纤维支气管镜检查的镇静方案一直尚无定论。本研究旨在评估瑞马唑仑联合阿芬太尼用于可弯曲纤维支气管镜检查的安全性和有效性，并为优化临床麻醉策略提供依据。
方法
本研究为随机、单盲对照试验。将118例行可弯曲纤维支气管镜检查的患者随机分为两组（每组59例）。两组均在镇静治疗前2分钟静脉注射阿芬太尼10μg/kg，随后分别给予0.2mg/kg瑞马唑仑（R组）或2mg/kg丙泊酚（P组）。在可弯曲纤维支气管镜检查期间，根据需要对每组患者给予试验药物以维持镇静深度（改良的观察者警觉/镇静评分≤3）。主要结局为低氧血症的发生率。次要结局包括其他安全性结局和有效性结局。
结果
共有115名参与者完成了研究。与P组相比，R组严重低氧血症的发生率较低（3.4%对15.8%，P=0.029）；R组注射痛和低血压的发生率较低（10.3%对33.3%，P=0.003）；R组低血压、头晕和咳嗽分级的发生率较低（P<0.05）。R组和P组的镇静成功率和诱导剂量时的镇静成功率相似（P>0.05）。与P组相比，R组的镇静恢复时间更短，R组的术者舒适度评分和患者舒适度评分更高（P<0.05）。
结论
瑞马唑仑联合阿芬太尼在可弯曲纤维支气管镜检查中显示出良好的临床潜力。与丙泊酚相比，它在维持相当的镇静成功率的同时，显著降低了严重低氧血症、注射痛、低血压、头晕和术中咳嗽的发生率。它还缩短了恢复时间，提高了术者和患者的舒适度评分。这些结果支持瑞马唑仑加阿芬太尼作为这种情况下一种安全、有效且耐受性良好的替代镇静方案。
