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

Recruiting now · Phase 4 · Has a placebo group

Conditions studied: Atrial Septal Defect (ASD), Dexmedetomidine, Delirium - Postoperative, Stress Response

In brief

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.

Key facts

Study ID

NCT06631534

Run by

Alexandria University

People needed

30

Starts

2024-04-03

Expected to finish

2024-12-01

Last updated by the study team

2024-10-15

Who can join

Age: 3 and older, up to 12. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Pediatric Patients 3-12 years of age admitted for device closure of ASD secundum

You may not qualify if…

• ASA IV, V
• Neurological problems (cerebral palsy, mental retardation, etc.,)
• Children with chromosomal abnormalities or other multiple congenital anomalies or other complex cardiac anomalies
• Hepatic or renal insufficiency
• History of allergy to the drugs used
• Previous Cardiac Surgery

Where it is running

• Alexandria University Hospitals - Semouha — Alexandria, Alexandria Governorate, Egypt (enrolling)

Full record on ClinicalTrials.gov

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