Remimazolam ED95 for Preoperative Sedation in Children with Obstructive Sleep Apnea, with Obesity or a Reference-Range BMI: A Biased-Coin Dose-Finding Study.
Fan Xiao, Tingyu Zhao, Cheng Xu et al.
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From the abstract
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).
Reported 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.
Authors' conclusions
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.