Clinical Trial

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

Recruiting Phase 4
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Record status
This record was last updated October 15, 2024 (before its estimated December 2024 completion). Its status may not reflect the trial's current state.
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.
Protocol Amendment History 1 amendment
This ClinicalTrials.gov record has been amended once since 2024-10-07.
Trial Details
NCT Number NCT06631534
Lead Sponsor Alexandria University
Conditions Atrial Septal Defect (ASD), Dexmedetomidine, Delirium - Postoperative, Stress Response
Enrollment 30 participants
Start Date 2024-04-03
Primary Completion 2024-12 (estimated)
Study Completion 2024-12 (estimated)
Updated on ClinicalTrials.gov 2024-10-15