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

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 .