Efficacy and safety of remimazolam tosilate in elderly patients undergoing
general anesthesia for bronchoscopy A randomized controlled trial
#MMPMID41188715
Hua D
; Jin S
; Min K
; Song J
; Pei S
; Li Y
; Duan R
BMC Anesthesiol
2025[Nov]; 25
(1
): 543
PMID41188715
show ga
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 .