Remimazolam versus Propofol for General Anesthesia in Elderly Patients Undergoing TAVI: A Randomized Controlled Trial

Abstract Background Remimazolam, a novel short-acting benzodiazepine, has emerged as a potential alternative to propofol for anesthesia. This study aimed to examine the effectiveness and safety of remimazolam compared to propofol for anesthesia in elderly patients undergoing transcatheter aortic valve implantation (TAVI) procedures. Methods We conducted a single-center, prospective, randomized controlled, non-inferiority trial in elderly patients undergoing TAVI under general anesthesia with a laryngeal mask airway (LMA). The eligibility criterion was age 65 to 80 years. Of 118 patients assessed for eligibility, 76 met the inclusion criteria and were randomized (39 remimazolam, 37 propofol). Patients were blinded to allocation; the treating anesthesiologist, who administered the agents and recorded the emergence times, was not blinded. The primary outcome was time to LMA removal, with a prespecified non-inferiority margin of 2 minutes. Results The remimazolam group demonstrated significantly faster recovery: LMA removal time was 9.7 ± 1.5 minutes versus 20.8 ± 2.0 minutes in the propofol group (mean difference − 11.1 minutes, 95% confidence interval (CI) − 11.9 to − 10.3; p < 0.001), indicating both non-inferiority and, as a post-hoc observation, superiority. Recovery of consciousness (6.7 ± 1.6 vs. 16.6 ± 2.2 minutes, p < 0.001) and time to spontaneous respiration (8.5 ± 1.5 vs. 19.4 ± 2.2 minutes, p < 0.001) were also significantly shorter with remimazolam. Total norepinephrine dose was lower in the remimazolam group (0.06 ± 0.03 vs. 0.17 ± 0.05 mg, p < 0.001), a descriptive finding not interpreted as evidence of hemodynamic superiority given the prophylactic-infusion protocol. Hospital length of stay did not differ significantly (10 [8–12] vs. 11 [10–13] days, p = 0.06). Conclusions In elderly patients undergoing TAVI under general anesthesia, remimazolam was associated with significantly faster recovery than propofol and met the prespecified non-inferiority margin for time to LMA removal; the large observed difference is a post-hoc, hypothesis-generating finding. Because the trial was single-center and retrospectively registered, these results should be interpreted with caution and require confirmation in protocolized, prospectively registered multicenter trials. Trial registration: Chinese Clinical Trial Registry (ChiCTR; https://www.chictr.org.cn/), ChiCTR2500109737. Registered on 24 September 2025; retrospectively registered.