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

Not Applicable

Recruiting

• Conditions: Local Infiltration; General Anesthesia; Dexmedetomidine; Ketamine; Atrial Septal Defect

• Registration Number: NCT06431178
• Lead Sponsor: Tanta University

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 Timeline

• Status Verified: 2024-05
• Study Start: 2024-05-01
• Study First Submitted: 2024-05-13
• Study First Submitted QC: 2024-05-25
• Last Update Submitted: 2024-05-27
• Study First Posted: 2024-05-28
• Last Update Posted: 2024-05-29
• Primary Completion: 2025-05-01
• Study Completion: 2025-05-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 60

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Heart rate	Immediately after the intervention	Heart rate will be measured at baseline, after induction ,10 min after catheter insertion site,30 min during procedure and post emergence in both groups.

Secondary Outcome Measures

Name	Time	Method
Lengh of hospital stay	28 days postoperative	Length of hospital stay will be measured from admission till discharge from hospital
Recovery time	Immediately after discharge from post-anesthesia care unit	Recovery time will be measured from the end of surgery till discharge from post-anesthesia care unit (PACU).
Complications	24 hours postoperative	Postoperative complications such as arrythmia, hypotension, bradycardia, nausea and vomiting will be measured.
O2 saturation	Immediately after the intervention	O2 saturation will be measured at baseline, after induction ,10 min after catheter insertion site,30 min during procedure and post emergence in both groups.
Mean arterial blood pressure	Immediately after the intervention	Mean arterial blood pressure will be measured at baseline, after induction ,10 min after catheter insertion site,30 min during procedure and post emergence in both groups.
Respiratory rate	Immediately after the intervention	Respiratory rate will be measured at baseline, after induction ,10 min after catheter insertion site,30 min during procedure and post emergence in both groups.

Trial Locations

Locations (1)

Aya Ebrahim Abdelhafez Mashal; 🇪🇬 Tanta, El-Gharbia Governorate, Egypt, Egypt