drugset / Trial / NCT04364945

Association Between Anesthetic Drugs for General Anesthesia and Postoperative Intelligence/behavioral Assessment Results in Children

NCT04364945 ↗

Active not recruiting 400 enrolled Seoul National University Hospital
RandomizedParallel-groupDouble-blindOther

Summary

In this study, we compared the results of the intelligence and behavioral test performed after surgery between the group using sevoflurane and the group receiving dexmedetomidine and remifentanil, in Korean children under 2 years of age who underwent surgery under general anesthesia.

Timeline

Start
2020-06-17
Primary completion
2028-05-30
Completion
2028-12-30

Outcome

Results reported · no primary-endpoint met/missed verdict (typical of a dose-finding / safety study)

paper The primary endpoint-full-scale IQ at 5 yr of age-will be reported after completion of long-term follow-up. PMID 40923823 ↗

Drugs

EvaluationDrugModalityDoseRoute
Subject Dexmedetomidine Other / unclassified 1 ug/kg —
Subject Remifentanil Small molecule 0.1 ug/kg —
Subject Remifentanil Small molecule 0.2 ug/kg —
Subject Sevoflurane Other / unclassified — —

Indications