Viewing Study NCT06431178



Ignite Creation Date: 2024-06-16 @ 11:49 AM
Last Modification Date: 2024-10-26 @ 3:30 PM
Study NCT ID: NCT06431178
Status: RECRUITING
Last Update Posted: 2024-05-29
First Post: 2024-05-13

Brief Title: General Anesthesia Versus Sedation By Dexmedetomidine and Ketamine With Local Infiltration for Percutaneous Transcatheter Closure of Atrial Septal Defect in Pediatric Patients
Sponsor: Tanta University
Organization: Tanta University

Study Overview

Official Title: 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
Status: RECRUITING
Status Verified Date: 2024-05
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: None
Brief 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
Detailed 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

Study Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: False
Is a FDA Regulated Device?: False
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: None