Pediatric anesthesia & critical care

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

Eur J AnaesthesiolPublished Dose-finding study

Authors' conclusion

This study explored the ED 50 and ED 95 of remimazolam for pre-operative sedation in children with left-to-right shunt CHD.

Study context

Population
Children aged 1 to 6 years with left-to-right shunt congenital heart disease (CHD), ASA II–III, receiving IV remimazolam for sedation; tertiary hospitals in Zhengzhou, Henan Province, 2023–2024completed the study
Participants
78 children
Comparison
Infants vs Toddlers vs Preschool children
Outcome
ED 50 and ED 95 of remimazolam for successful sedation
Follow-up
5 min after IV administration
Methodological detailsDixon sequential method, nonrandomised, nonblinded
  • Dixon sequential method
  • Nonrandomised
  • Nonblinded

Main finding

As reported in the abstract

GroupED 50 (95% CI)ED 95 (95% CI)
Infants0.209 (0.184 to 0.234)0.356 (0.282 to 0.672)
Toddlers0.259 (0.234 to 0.284)0.404 (0.330 to 0.741)
Preschool children0.266 (0.207 to 0.325)0.408 (0.334 to 0.752)

ED 50 (95% CI)

Infants0.209 (0.184 to 0.234)
Toddlers0.259 (0.234 to 0.284)
Preschool children0.266 (0.207 to 0.325)

ED 95 (95% CI)

Infants0.356 (0.282 to 0.672)
Toddlers0.404 (0.330 to 0.741)
Preschool children0.408 (0.334 to 0.752)

Safety

No serious adverse reactions observed with IV remimazolam

Original publication

Remimazolam for successful sedation in children with left-to-right shunt congenital heart disease: An up-and-down sequential allocation trial. Eur J Anaesthesiol. Published 4 April 2025. doi:10.1097/eja.0000000000002183

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