Comparative Evaluation of Remimazolam Besylate versus Propofol for Pediatric MRI Sedation: Safety, Recovery, and Adverse Event Profiles.

OBJECTIVE

To evaluate the safety and efficacy of remimazolam besylate compared with propofol for pediatric MRI sedation.

METHODS

Seventy-nine children undergoing MRI were randomly assigned to the remimazolam (R, n=39) or propofol (P, n=40) group. The primary observation indicator was the sedation success rate. Secondary indicators included the frequency of supplemental dosing, induction time, recovery time, and the incidence of adverse events (hypoxia, severe hypoxia, injection pain, hypotension, and bradycardia). Logistic regression and Spearman correlation were used to identify risk factors for adverse events.

RESULTS

Sedation success rates were similar between groups (R: 92.3%, P: 95.0%; P=0.977). The R group showed longer induction (51.3 ± 25.9 s vs 38.5 ± 17.5 s, P=0.012) but faster recovery (12.1 ± 3.8 min vs 15.9 ± 4.6 min, P<0.001) and required fewer supplemental doses (≥2 doses: 23.1% vs 57.5%, P=0.002). Adverse events were less frequent with remimazolam. Logistic regression analysis revealed that recovery time, choice of sedative, and frequency of drug supplementation were significant risk factors for adverse events during pediatric MRI sedation. Prolonged recovery time (OR=1.454, 95% CI: 1.077-1.962, P=0.015) increased the risk of adverse events, whereas the use of remimazolam besylate significantly reduced this risk compared to propofol (OR=0.265, 95% CI: 0.145-0.486, P < 0.001). Patients needing ≥2 supplemental doses had higher risk (OR=2.188, 95% CI: 1.155-4.145, P=0.016). After adjustment, recovery time (adjusted OR=1.384, 95% CI: 1.064-1.800, P=0.015), ≥2 supplementations (adjusted OR=1.828, 95% CI: 1.267-2.637, P=0.001), and sedative type (adjusted OR=0.435, 95% CI: 0.214-0.883, P=0.021) remained independent predictors. Correlation analysis confirmed significant associations between recovery time, sedative choice, supplementation frequency, and adverse event occurrence (all P<0.05).

CONCLUSION

Remimazolam besylate and propofol are both safe and effective for pediatric MRI sedation, but remimazolam besylate is superior due to faster recovery and fewer adverse events.

CLINICAL TRIAL NUMBER: This study was prospectively registered with the Chinese Clinical Trial Registry (ChiCTR), registration number: ChiCTR2500097093.