Comparing general anesthesia and sedation methods for heart defect closure in children
A Comparative Study Between General Anesthesia Versus Sedation By Dexmedetomidine and Ketamine With Local Infiltration for Percutaneous Transcatheter Closure of Atrial Septal Defect in Pediatric Patients
This study is testing whether using sedation instead of general anesthesia during heart defect closure in children can lead to safer outcomes and better stability during the procedure.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 60 (estimated) |
| Ages | 3 Years to 8 Years |
| Sex | All |
| Sponsor | Tanta University Academic / other |
| Locations | 1 site (Tanta, El-Gharbia Governorate, Egypt) |
| Trial ID | NCT06431178 on ClinicalTrials.gov |
What this trial studies
This study aims to compare the effects of general anesthesia versus sedation using dexmedetomidine and ketamine, along with local infiltration, in pediatric patients undergoing transcatheter closure of atrial septal defects. Atrial septal defect is a common congenital heart defect, and the study focuses on how different anesthesia techniques impact hemodynamic stability during the procedure. The use of ketamine and dexmedetomidine may provide a safer alternative to general anesthesia by minimizing respiratory complications and maintaining hemodynamic stability.
Who should consider this trial
Good fit: Ideal candidates are pediatric patients aged 3-8 years with ASA physical status II-III scheduled for elective atrial septal defect closure.
Not a fit: Patients with multiple congenital anomalies, congestive heart failure, or significant organ dysfunction may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to safer anesthesia practices for children undergoing heart defect repairs.
How similar studies have performed: Other studies have shown promising results with sedation techniques similar to those being tested, indicating potential for success.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Aged 3-8 years old. * Both genders. * American Society of Anesthesiologists (ASA) physical status II-III * Pediatric patients scheduled for elective transcatheter atrial septal defect closure. Exclusion Criteria: * Patients with multiple congenital anomalies. * Patients with congestive heart failure * Patients with Organ dysfunction liver or renal disease or pulmonary disease. * Recent chest infection. * Airway abnormalities.
Where this trial is running
Tanta, El-Gharbia Governorate, Egypt
- Aya Ebrahim Abdelhafez Mashal — Tanta, El-Gharbia Governorate, Egypt, Egypt (Recruiting)
Study contacts
- Study coordinator: Aya E Mashal, Master
- Email: ayaebrahim406@gmail.com
- Phone: 00201009167298
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.