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Efficacy and safety of remimazolam tosilate in elderly patients undergoing general anesthesia for bronchoscopy. A
Dongsheng Hua1, Shuqing Jin1, Keting Min1
1Department of Anesthesiology, Shanghai Pulmonary Hospital, School of Medicine, Tongji University, 507 Zhengmin Road, Shanghai, 200433, China.
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 .
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