Abstract
BACKGROUND: The findings of this study offer insights into the utilisation of remimazolam for sedation in paediatric patients with left-to-right shunt congenital heart disease (CHD). OBJECTIVE: To study the median effective dose (ED 50 ) and 95 percentile of the effective dose (ED 95 ) of remimazolam for successful sedation in children with CHD. DESIGN: A nonrandomised, nonblinded study based on the Dixon sequential method. SETTING: Tertiary hospitals in Zhengzhou, Henan Province, study dates: 20 October 2023 to 18 May 2024. PATIENTS: A total of 78 patients, comprising 32 males and 45 females, successfully completed the study. They were selected based on the following criteria: children aged 1 to 6 years with left-to-right shunt CHD; ASA physical status II-III. The key exclusion criteria were: history of allergy to sedative drugs; administration of sedative medications other than the study drug before surgery; severe pre-operative liver or kidney dysfunction; pre-operative bradycardia; and severe pre-operative respiratory diseases. INTERVENTION: The sedation status of the patients was observed for 5 min after intravenous administration of different doses of remimazolam. MAIN OUTCOME MEASURES: The ED 50 and ED 95 of remimazolam for successful sedation in children with CHD. RESULTS: The ED 50 (95% CI) of remimazolam for successful sedation in infants, toddlers and preschool children with CHD were 0.209 (0.184 to 0.234) mg kg -1 , 0.259 (0.234 to 0.284) mg kg -1 and 0.266 (0.207 to 0.325) mg kg -1 , respectively. ED 95 (95% CI) were 0.356 (0.282 to 0.672) mg kg -1 , 0.404 (0.330 to 0.741) mg kg -1 and 0.408 (0.334 to 0.752) mg kg -1 , respectively. No serious adverse reactions were observed with intravenous remimazolam. CONCLUSION: This study explored the ED 50 and ED 95 of remimazolam for pre-operative sedation in children with left-to-right shunt CHD. It provides guidance for pre-operative sedation medication in children with left-to-right shunt CHD. TRIAL REGISTRATION: https://www.chictr.org.cn/Identifier: ChiCTR2300076458.