Actively Recruiting
Effect of Dexmedetomidine Supplementation to General Anaesthesia in Pediatric Transcatheter Closure of Atrial Septal Defect
Led by Alexandria University · Updated on 2024-10-15
30
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
This trial investigates the use of dexmedetomidine to improve recovery quality and maintain stable heart function in children aged 3 to 12 undergoing interventional catheter closure of atrial septal defect (ASD). Researchers also aim to understand whether dexmedetomidine reduces stress responses and affects recovery timing like time to extubation and emergence delirium in this pediatric group. Participants receive either dexmedetomidine or a placebo alongside general anesthesia with sevoflurane. Dexmedetomidine is given as a loading dose of 1 microgram per kilogram over 10 minutes, followed by an infusion of 0.5 microgram per kilogram per hour via a syringe pump. The placebo group receives a matching saline infusion prepared by an independent party. Hemodynamic parameters are monitored before, during, and after the procedure. Throughout the study, heart rate, blood pressure, and cardiac output are measured at baseline and perioperatively. Researchers also assess recovery quality, recovery time, time to extubation, stress hormone levels, and any side effects. The trial includes close monitoring of emergence delirium and stress hormone sampling before and after the procedure, with the goal of understanding dexmedetomidine's effects on pediatric recovery and stress during ASD closure.
CONDITIONS
Brief 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 aged 3 to 12 years
- Admitted for device closure of atrial septal defect 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
- Complex cardiac anomalies
- Hepatic or renal insufficiency
- History of allergy to study drugs
- Previous cardiac surgery
AI-Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - During the procedure
Participants receive general anesthesia with sevoflurane and are supplemented with either dexmedetomidine or placebo during the transcatheter closure of atrial septal defect.
1 procedure visit (in-person)
Duration - Perioperative period
Participants are monitored perioperatively for hemodynamic stability, recovery quality, and side effects following the procedure.
1 to 2 visits depending on recovery
Trial Site Locations
Total: 1 location
1
Alexandria University Hospitals - Semouha
Alexandria, Alexandria Governorate, Egypt
Actively Recruiting
Research Team
M
Mohamed Okasha, Specialist - MSc
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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