Safety and efficacy of remimazolam combined with alfentanil in flexible fiberoptic bronchoscopy: A randomized controlled trial

Abstract

Objective: The 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. Methods: This 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. Results: A 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%, P = 0.029); the incidences of injection pain and hypotension in Group R were lower (10.3% vs. 33.3%, P = 0.003); and the incidences of hypotension, dizziness, and grade of cough in Group R were lower (P < 0.05). The sedation success rate and sedation success rate at an induced dose were similar between Groups R and P (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 (P < 0.05). Conclusions: Remimazolam, 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.