The Effect of Remimazolam Anesthesia on Patients undergoing Elective Surgery in Iraq

Abstract

Background: Optimizing pediatric sedation remains challenging due to developmental variability in drug response. While the ultra-short-acting benzodiazepine remimazolam offers superior hemodynamic stability and predictable esterase-based metabolism, its clinical application is limited. To address this, rigorous dose-finding studies are essential to establish the 95% effective dose, ensuring safer and more standardized anesthetic protocols for children.
Methods: This was a prospective, age-stratified, single-center dose-finding study. This study was conducted on children undergoing elective surgery. Patients were stratified into two age groups based on predefined age criteria: preschool and school-aged children. The initial intravenous dose of remimazolam was 0.2 mg/kg, followed by a subsequent 0.05 mg/kg dose administered through a sequential ascending-descending method based on the patient’s response. Vital signs and recovery outcomes were monitored throughout the procedure. The ED95 was estimated using isotonic regression with bootstrap confidence intervals, and statistical analyses were performed using appropriate nonparametric and mixed-effects methods.
Results: This study included 80 children (40 preschoolers, 40 school-aged). Remimazolam demonstrated predictable hemodynamic effects with group-specific heart rate responses. The estimated ED95 was 0.389 mg/kg for preschoolers and 0.362 mg/kg for school-aged children. Adverse events were rare and transient. While anesthesia and operation times were similar, preschoolers experienced significantly longer wake-up times (P<0.001).
Conclusion: Remimazolam provides safe and effective sedation for elective pediatric surgery, with predictable hemodynamic responses and a favorable safety profile. While the estimated ED95 varies slightly between preschool and school-aged children, both groups achieve adequate sedation.