Non-Inferiority Trial of Remimazolam vs. Propofol for Fast-Track Anesthesia in Congenital Heart Disease Patients

Background and objective: Remimazolam, a new member of benzodiazepine, has been used as an alternative to Propofol during anesthesia induction. In this study, we aimed to examine the effectiveness and safety of Remimazolam in comparison to Propofol for both the induction and maintenance of fast-track general anesthesia in children undergoing surgery for CHD. Methods: We carried out a single-centre, prospective, double-blinded, randomized controlled, non-inferiority trial among 101 children, of whom 57 received Remimazolam and 44 received Propofol. All the children underwent ASD surgery and had a physical status of ASA-II before surgery. The primary outcome was considered the time to extubation. Results: We included all 101 patients in the final analysis. The results of this study showed that the Remimazolam group’s patients took a significantly amount of short time to extubate (MD: -7.97, 95% CI: -8.91 to -7.02, p<0.001); their hospitalizations days were shorter than the Propofol group’s patients (median: 5 days vs 7 days, p<0.001); PAED score was lower than Propofol group (median 3 vs 6, p<0.001), indicating reduced occurrence of postoperative emergence delirium. The hemodynamic stability was found to be more stable in the Remimazolam group, and in the Remimazolam group, only 27% of the participants required vasopressor agents, whereas in the Propofol group, around two-thirds of the participants required a vasopressor agent. Conclusions: This study highlighted the potential benefits of Remimazolam over Propofol in many aspects and generated valuable evidence for children who require surgical intervention with rapid recovery and stable hemodynamics. Trial registration number: ChiCTR2500109737, Registration date: 24 Sep. 2025 Retrospectively registered