General Anesthesia Versus Sedation By Dexmedetomidine and Ketamine With Local Infiltration for Percutaneous Transcatheter Closure of Atrial Septal Defect in Pediatric Patients
Launched by TANTA UNIVERSITY · May 25, 2024
Trial Information
Current as of February 19, 2025
Recruiting
Keywords
ClinConnect Summary
This clinical trial is comparing two different ways to help children feel comfortable during a specific heart procedure called transcatheter closure of atrial septal defect, which is done to fix a small hole in the heart. The two methods being studied are general anesthesia, where the child is fully asleep, and sedation using a combination of medications called dexmedetomidine and ketamine, along with a local numbing medicine at the site where the catheter is inserted. The goal is to see how these methods affect the child’s heart and overall health during the procedure.
Children between the ages of 3 and 8 years old may be eligible to participate if they are generally healthy but may have some mild health issues. However, children with serious conditions, such as multiple congenital anomalies or significant heart or lung problems, cannot join the study. If a child takes part, they will receive either the general anesthesia or the sedation during the procedure, and the doctors will carefully monitor how they respond. This trial will help understand which method might be better for young patients undergoing this heart procedure.
Gender
ALL
Eligibility 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.
About Tanta University
Tanta University is a prestigious academic institution located in Egypt, dedicated to advancing medical research and education. As a clinical trial sponsor, Tanta University leverages its extensive resources and expertise to conduct innovative research initiatives aimed at improving health outcomes. The university collaborates with a network of healthcare professionals, researchers, and institutions to facilitate rigorous clinical trials across various medical disciplines. Committed to ethical standards and scientific integrity, Tanta University strives to contribute to the global body of knowledge while fostering the next generation of medical professionals.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Tanta, El Gharbia Governorate, Egypt, Egypt
People applied
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported
Discussion 0