Using Dexmedetomidine to Improve Recovery in Children Undergoing Heart Defect Closure
Effect of Dexmedetomidine Supplementation to General Anaesthesia in Paediatric Transcatheter Closure of Atrial Septal Defect
This study is testing if adding a medication called dexmedetomidine to anesthesia can help kids aged 3-12 recover better and feel less stressed after heart surgery to fix a hole in their heart.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 30 (estimated) |
| Ages | 3 Years to 12 Years |
| Sex | All |
| Sponsor | Alexandria University Academic / other |
| Locations | 1 site (Alexandria, Alexandria Governorate) |
| Trial ID | NCT06631534 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the effects of dexmedetomidine, an α2-adrenoreceptor agonist, as a supplement to general anesthesia in pediatric patients undergoing transcatheter closure of atrial septal defects (ASD). The study aims to determine if dexmedetomidine can maintain stable hemodynamics while improving recovery quality and reducing postoperative stress responses. Participants will be randomly assigned to receive either dexmedetomidine or a placebo, with their hemodynamic parameters and recovery quality monitored throughout the process. The trial focuses on children aged 3-12 years who are scheduled for this procedure.
Who should consider this trial
Good fit: Ideal candidates for this study are pediatric patients aged 3-12 years who are scheduled for device closure of ASD secundum.
Not a fit: Patients with severe comorbidities, neurological issues, or complex congenital anomalies may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could lead to improved recovery experiences and outcomes for pediatric patients undergoing heart defect closure.
How similar studies have performed: Other studies have shown promising results with dexmedetomidine in similar contexts, suggesting potential for success in this trial.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Pediatric Patients 3-12 years of age admitted for device closure of ASD secundum Exclusion Criteria: * 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 this trial is running
Alexandria, Alexandria Governorate
- Alexandria University Hospitals - Semouha — Alexandria, Alexandria Governorate, Egypt (Recruiting)
Study contacts
- Study coordinator: Mohamed Okasha, Specialist - MSc
- Email: m_adel13@alexmed.edu.eg
- Phone: 0201006462352
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.