Drug Design Development and Therapy
Remimazolam ED95 for Preoperative Sedation in Children with Obstructive Sleep Apnea, with Obesity or a Reference-Range BMI: A Biased-Coin Dose-Finding Study
By Fan Xiao, Tingyu Zhao, Cheng Xu and 3 others.
Abstract
Background
Obesity may alter total-body-weight dosing of remimazolam, whereas obstructive sleep apnea narrows the respiratory safety margin. We estimated the ED95 for protocol-defined preoperative sedation in children with obesity or a reference-range body mass index (BMI).
Methods
In this prospective, single-center sequential dose-finding study, 80 children aged 3– 17 years with a clinical OSA diagnosis undergoing adenoidectomy and/or tonsillectomy entered study-defined obesity (BMI-for-age > 95th percentile) or reference-BMI (25th– 84th percentile) groups (40 each). Independent biased-coin sequences used total-body-weight doses, starting at 0.20 mg/kg with 0.05 mg/kg steps. The response was a Ramsay Sedation Scale (RSS) score ≥ 4 at 3 minutes after completion of a 1-minute intravenous bolus. Isotonic regression and 2000 bootstrap resamples yielded ED95 estimates and bias-corrected percentile 95% confidence intervals (CIs).