Remimazolam-Propofol and Propofol Induction Regimens for Pediatric Bidirectional Endoscopy: A Three-Arm Randomized Trial.

Background/Objectives: Propofol is effective for pediatric endoscopy but can depress ventilation. We compared three induction regimens in school-aged children undergoing bidirectional gastrointestinal endoscopy. Methods: This single-center, assessor-blinded randomized trial allocated children aged 6-12 years (1:1:1) to propofol 3 mg/kg (P), remimazolam 0.2 mg/kg plus propofol 1 mg/kg (R1), or remimazolam 0.4 mg/kg plus propofol 1 mg/kg (R2). All groups received sufentanil and standardized propofol maintenance. Respiratory depression was a respiratory rate < 10 breaths/min or peripheral oxygen saturation < 90% for >1 min. The trial was prospectively registered (ChiCTR2500096218), and analysis followed assigned groups. Results: The analysis included 120 children (40 per group). Respiratory depression occurred in 32/40 (80.0%) in P, 6/40 (15.0%) in R1, and 14/40 (35.0%) in R2 (overall p < 0.001). Compared with P, the risk difference was -65.0 percentage points for R1 (95% confidence interval [CI], -77.4 to -44.6; risk ratio, 0.19; 95% CI, 0.09-0.37) and -45.0 percentage points for R2 (95% CI, -61.0 to -23.6; risk ratio, 0.44; 95% CI, 0.27-0.66); both Holm-adjusted p values were <0.001. Mean time to eye opening was 12.7, 11.2, and 16.9 min, respectively. In the exploratory R1-versus-R2 comparison, time to eye opening was 5.75 min shorter with R1 (95% CI, 4.28-7.20). Conclusions: Both remimazolam-propofol regimens reduced monitor-defined respiratory depression compared with propofol 3 mg/kg. The 0.2 mg/kg remimazolam-propofol regimen combined this respiratory benefit with faster recovery than the 0.4 mg/kg regimen in exploratory analysis, supporting its further evaluation as an induction strategy for pediatric bidirectional endoscopy.