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Search / Trial NCT06431178

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.

Locations

Tanta, El Gharbia Governorate, Egypt, Egypt

People applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

Discussion 0