drugset / Trial / NCT04263844

Intranasal Dexmedetomidine Versus Intranasal Midazolam for Emergence Delirium Prevention

NCT04263844 ↗

Phase 4 Completed 66 enrolled Indonesia University
RandomizedParallel-groupSingle-blindPrevention

Summary

This study is a double-blind clinical trial, in pediatric patients aged 1-12 years with physical status ASA (American Society of Anesthesiology) 1 and 2 who underwent eye surgery under general anesthesia using Sevoflurane inhalation agents, in investigator institution during February-May 2019.. There were 64 children obtained by consecutive sampling, who underwent eye surgery in investigator institution during February-May 2019. The subjects then grouped into dexmedetomidine group and midazolam group. Effectiveness was assessed from Emergence Delirium (ED) events, recovery time, and post-premedication desaturation events. Data analysis using Chi Square test and Mann-Whitney test.

Timeline

Start
2019-01-10
Primary completion
2019-10-10
Completion
2019-10-10

Drugs

EvaluationDrugModalityDoseRoute
Comparator Dexmedetomidine Other / unclassified 1 ug/kg Intranasal
Comparator Midazolam Small molecule 0.1 mg/kg Intranasal

Indications