Drug design, development and therapy · 2026
Remimazolam ED95 for Preoperative Sedation in Children with Obstructive Sleep Apnea, with Obesity or a Reference-Range BMI: A Biased-Coin Dose-Finding Study.
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Xiao Fan, Zhao Tingyu, Xu Cheng, Yao Jun, Wei Rong, Jiang Yan
Аннотация
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).
RESULTS: Responses occurred in 35/40 (87.5%) participants in the obesity group and 34/40 (85.0%) in the reference-BMI group. ED95 estimates were 0.38 mg/kg (95% CI, 0.32-0.39) and 0.44 mg/kg (95% CI, 0.39-0.44), respectively. The difference was -0.05 mg/kg (95% CI, -0.13 to 0.05). During 15-minute observation, one child per group developed hypoxemia (SpO2 93%) that resolved after a jaw-thrust maneuver. One reference-BMI participant developed bradycardia (50 beats/min), which responded to atropine. No child had a ≥30% decrease in mean arterial pressure.
CONCLUSION: The protocol-specific ED95 values of a 1-min remimazolam bolus for RSS ≥4 at 3 min were 0.38 mg/kg in children with obesity and 0.44 mg/kg in children with a reference-range 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).
RESULTS: Responses occurred in 35/40 (87.5%) participants in the obesity group and 34/40 (85.0%) in the reference-BMI group. ED95 estimates were 0.38 mg/kg (95% CI, 0.32-0.39) and 0.44 mg/kg (95% CI, 0.39-0.44), respectively. The difference was -0.05 mg/kg (95% CI, -0.13 to 0.05). During 15-minute observation, one child per group developed hypoxemia (SpO2 93%) that resolved after a jaw-thrust maneuver. One reference-BMI participant developed bradycardia (50 beats/min), which responded to atropine. No child had a ≥30% decrease in mean arterial pressure.
CONCLUSION: The protocol-specific ED95 values of a 1-min remimazolam bolus for RSS ≥4 at 3 min were 0.38 mg/kg in children with obesity and 0.44 mg/kg in children with a reference-range BMI.