Work

Efficacy and safety of remimazolam tosilate in elderly patients undergoing general anesthesia for bronchoscopy. A randomized controlled trial

Year: 2025

Type: article

Study designs: Randomized Controlled Trial, Clinical Trial

Abstract: BACKGROUND: Remimazolam, a novel ultrashort-acting benzodiazepine, has been successfully used for the induction and maintenance of procedural sedation and general anesthesia. It may provide effective general anesthesia for elderly patients undergoing bronchoscopy. OBJECTIVE: To evaluate the safety and efficacy of remimazolam tosilate versus propofol in elderly patients undergoing general anesthesia for bronchoscopy. DESIGN: Prospective, single-blind, randomized clinical trial. SETTING: Single-center study conducted from November 2023 to April 2024. PATIENTS: 118 elderly patients (≥ 65 years) undergoing general anesthesia for bronchoscopy. INTERVENTIONS: Patients were randomly assigned 1:1 to receive propofol or remimazolam. MAIN OUTCOME MEASURES: The primary outcome was anesthesia success rate, defined as successful bronchoscopy completion with a Modified Observer's Assessment of Alertness/Sedation (MOAA/S) score of 0 without rescue anesthesia. Secondary outcomes included vital signs, anesthesia characteristics, and adverse events. RESULTS: There was no significant difference in the anesthesia success rate between the two groups (P = 0.559). The onset time, MOAA/S score at extubation, hypertension, hypoxemia, tachycardia, and bradycardia were similar between the groups (P > 0.05), as were emergence agitation, nausea/vomiting, and intraoperative awareness (P > 0.05). Compared to propofol, remimazolam was associated with significantly shorter durations of hypotension, reduced injection pain, and faster awakening time (P < 0.01). CONCLUSION: Remimazolam tosilate demonstrated non-inferior safety and efficacy to propofol for general anesthesia during bronchoscopy in elderly patients. Remimazolam was associated with a lower incidence of injection pain and hypotension. Additionally, when reversed with flumazenil, remimazolam provided significantly faster recovery times compared to propofol, potentially enhancing bronchoscopy efficiency. CLINICAL TRIAL NUMBER: Clinical trial number and registry URL: ChiCTR2300076845, registration date: October 22, 2023; http://www.chictr.org.cn .

Source: BMC Anesthesiology

DOI: 10.1186/s12871-025-03318-1