Remimazolam for successful sedation in children with left-to-right shunt congenital heart disease: An up-and-down sequential allocation trial.

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.