Non-inferiority trial of remimazolam versus propofol for fast-track anesthesia in children undergoing percutaneous closure of atrial septal defect.

BACKGROUND AND

OBJECTIVE

Remimazolam, a new member of the benzodiazepine class, has been used as an alternative to propofol during anesthesia induction. In this study, we aimed to examine the effectiveness and safety of remimazolam compared with propofol for both the induction and maintenance of fast-track general anesthesia in children undergoing percutaneous closure of an atrial septal defect (ASD).

METHODS

We carried out a single-center, prospective, randomized controlled, observer-blinded, non-inferiority trial among 101 children, of whom 57 received remimazolam and 44 received propofol. All children underwent percutaneous closure of an atrial septal defect and had an American Society of Anesthesiologists (ASA) physical status of II before surgery. The primary outcome was the time to laryngeal mask airway (LMA) removal, measured in minutes.

RESULTS

We included all 101 patients in the final analysis. Children in the remimazolam group had a significantly shorter time to LMA removal (mean difference [MD]: ‑7.97 min; 95% CI: ‑8.91 to ‑7.02; p < 0.001) and a shorter duration of hospitalization (median 5 vs. 7 days; p < 0.001) than the propofol group. The Pediatric Anesthesia Emergence Delirium (PAED) score was also lower in the remimazolam group (median 3 vs. 6; p < 0.001), indicating a reduced occurrence of postoperative emergence delirium. Fewer children in the remimazolam group required a vasopressor (26% vs. 64%). Mean arterial pressure and heart rate each showed a significant intervention-by-time interaction (their trajectories over time differed between groups), without a significant overall between-group difference in either.

CONCLUSIONS

This study suggests that remimazolam offers advantages over propofol for fast-track anesthesia in children undergoing percutaneous ASD closure, including faster LMA removal, shorter hospitalization, and a lower incidence of postoperative emergence delirium, with a differing intraoperative mean arterial pressure trajectory and comparable overall hemodynamic stability.

TRIAL REGISTRATION NUMBER: ChiCTR2500109737, Registration date: 24 Sep. 2025. Retrospectively registered.