General Anesthesia Versus Sedation By Dexmedetomidine and Ketamine With Local Infiltration for Percutaneous Transcatheter Closure of Atrial Septal Defect in Pediatric Patients

Last updated: February 15, 2026
Sponsor: Tanta University
Overall Status: Completed

Phase

N/A

Condition

Pentalogy Of Cantrell

Heart Defect

Anesthesia

Treatment

Local anesthesia

General Anesthesia

Clinical Study ID

NCT06431178
36264MD57/3/23
  • Ages 3-8
  • All Genders

Study Summary

The aim of the present study is to compare between general anesthesia versus sedation with dexmedetomidine and ketamine with local infilteration at the catheter insertion site in pediatric patients undergoing transcutaneous closure of atrial septal defect on hemodynamic changes.

Eligibility Criteria

Inclusion

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 defectclosure.

Exclusion

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.

Study Design

Total Participants: 60
Treatment Group(s): 2
Primary Treatment: Local anesthesia
Phase:
Study Start date:
May 01, 2024
Estimated Completion Date:
August 01, 2025

Study Description

Atrial septal defect (ASD) is one of the most common types of congenital heart defects, occurring in about 25% of children General anaesthesia is usually obtained with tracheal intubation and mechanical ventilation or spontaneous breathing, the depth of anesthesia required to tolerate the presence of a tracheal tube will invariably lead to some reduction in myocardial contractility and alteration of respiratory mechanics. The goal of anesthetic technique is to provide sedation and analgesia during cardiac catheterization to ensure immobility and hemodynamic stability.

Ketamine is an N-methyl-D-aspartate receptor (NMDA) antagonist with sedative, analgesic, and sympathomimetic effects. Among its benefits ,it has the ability to protect airway reflexes with minimal effect on ventilatory drive.

Dexmedetomidine is a highly selective alpha-2 adrenoreceptor agonist with sedative, anxiolytic, and analgesic effect, it also blunts the sympathetic nervous system response to surgical stimulation.

Connect with a study center

  • Aya Ebrahim Abdelhafez Mashal

    Tanta, El-Gharbia Governorate, Egypt 31527
    Egypt

    Site Not Available

  • Aya Ebrahim Abdelhafez Mashal

    Tanta 347497, El-Gharbia Governorate, Egypt 31527
    Egypt

    Site Not Available

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