drugset / Trial / NCT06482125

Emergence Agitation Between Dexmedetomidine and Sevoflurane Anesthesia

NCT06482125 ↗

Completed 121 enrolled Pelita Harapan University
RandomizedParallel-groupSingle-blindPrevention

Summary

Emergence agitation is commonly encountered after receiving inhalation anesthesia. This distressing phenomenon carries risks that are harmful to patients, caregivers and medical personnel. Using total intravenous Dexmedetomidine, the investigators seek to reduce agitation and provide gentle emergence from anesthesia.

Timeline

Start
2024-07-31
Primary completion
2024-12-31
Completion
2024-12-31

Outcome

Mixed primary results

registry MEAN Inhalation Sevoflurane: 3.9 (Standard Deviation 0.9) Score on a scale NCT06482125 ↗

registry MEAN Total Intravenous Dexmedetomidine: 2.5 (Standard Deviation 0.6) Score on a scale NCT06482125 ↗

registry analysis (superiority test); Inhalation Sevoflurane vs Total Intravenous Dexmedetomidine; p = 0.001; Odds Ratio (OR) 40.955 (95% CI 14.098 to 118.972) NCT06482125 ↗

registry analysis (equivalence test); Inhalation Sevoflurane vs Total Intravenous Dexmedetomidine; p = 0.345; Wilcoxon (Mann-Whitney) NCT06482125 ↗

registry analysis (equivalence test); Inhalation Sevoflurane vs Total Intravenous Dexmedetomidine; p = 0.450; Wilcoxon (Mann-Whitney) NCT06482125 ↗

Drugs

EvaluationDrugModalityDoseRoute
Subject Dexmedetomidine Other / unclassified 1.5 ug/kg Intravenous
Comparator Sevoflurane Other / unclassified 2 % Inhaled
Comparator Sevoflurane Other / unclassified 3 % Inhaled

Indications