drugset / Trial / NCT06631534

Effect of Dexmedetomidine Supplementation to General Anaesthesia in Paediatric Transcatheter Closure of Atrial Septal Defect

NCT06631534 ↗

Phase 4 Recruiting 30 enrolled Alexandria University
RandomizedParallel-groupQuadruple-blindTreatment

Summary

The aim of this randomized trial is to determine efficacy of dexmedetomidine in improving quality of recovery in pediatric patients undergoing interventional catheter closure of ASD while maintaining the hemodynamic parameters. Additionally he stress reducing effects of dexmedetomidine will be investigated in this population . The main questions it aims to answer are: Does Dexmedetomidine maintain stable hemodynamics in pediatric patients undergoing transcatheter ASD Closure while improving their quality of recovery? Does dexmedetomidine prolong duration of recovery and time to extubation in pediatric patients ? Does dexmedetomidine exert stress reducing properties in this population? Participants will: Either be administered Dexmedetomidine in a loading/maintenance regimen or a placebo, with hemodynamics being monitored at the baseline, intraoperatively and postoperatively, with recovery time and quality of recovery especially emergence delirium being monitored. Stress hormone levels will be sampled at baseline and postoperatively.

Timeline

Start
2024-04-03
Primary completion
2024-12
Completion
2024-12

Drugs

EvaluationDrugModalityDoseRoute
Comparator Dexmedetomidine Other / unclassified 0.5 ug/kg Intravenous