Clinical trial NCT06431178: General Anesthesia Versus Sedation By Dexmedetomidine and Ketamine With Local Infiltration for Percutaneous Transcatheter Closure of Atrial Septal Defect in Pediatric Patients
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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: General Anesthesia
Dexmedetomidine
Ketamine
Local Infiltration
Atrial Septal Defect
Lead sponsor: Tanta University
Sponsor class: OTHER
First posted: 2024-05-28
Enrollment: 60
Sex: ALL
Minimum age (years): 3
Maximum age (years): 8
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.

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.

Primary outcomes:
measure: Heart rate
timeFrame: Immediately after the intervention
Secondary outcomes:
measure: Mean arterial blood pressure
timeFrame: Immediately after the intervention
measure: O2 saturation
timeFrame: Immediately after the intervention
measure: Respiratory rate
timeFrame: Immediately after the intervention
measure: Lengh of hospital stay
timeFrame: 28 days postoperative
measure: Recovery time
timeFrame: Immediately after discharge from post-anesthesia care unit
measure: Complications
timeFrame: 24 hours postoperative
Other outcomes:
Locations:
city: Tanta
country: Egypt
facility: Aya Ebrahim Abdelhafez Mashal
state: El-Gharbia Governorate, Egypt
Study officials:
References: