Actively Recruiting
Effect of Dexmedetomidine Supplementation to General Anaesthesia in Paediatric Transcatheter Closure of Atrial Septal Defect
Led by Alexandria University · Updated on 2024-10-15
30
Participants Needed
1
Research Sites
34 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Effect of Dexmedetomidine Supplementation to General Anaesthesia in Paediatric Transcatheter Closure of Atrial Septal Defect
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Pediatric patients 3 to 12 years of age admitted for device closure of ASD secundum
You will not qualify if you...
- ASA physical status IV or V
- Neurological problems such as cerebral palsy or mental retardation
- Chromosomal abnormalities or multiple congenital anomalies or complex cardiac anomalies
- Hepatic or renal insufficiency
- History of allergy to the drugs used
- Previous cardiac surgery
AI-Screening
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Trial Site Locations
Total: 1 location
1
Alexandria University Hospitals - Semouha
Alexandria, Alexandria Governorate, Egypt
Actively Recruiting
Research Team
M
Mohamed Okasha, Specialist - MSc
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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