Clinical trial NCT06631534: Effect of Dexmedetomidine Supplementation to General Anaesthesia in Paediatric Transcatheter Closure of Atrial Septal Defect
Official title: Effect of Dexmedetomidine Supplementation to General Anaesthesia in Paediatric Transcatheter Closure of Atrial Septal Defect
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE4
Conditions: Atrial Septal Defect (ASD)
Dexmedetomidine
Delirium - Postoperative
Stress Response
Keywords: Atrial septal Defect
ASD
Dexmedetomidine
Echocardiography
Cardiac index
PAED
VTI
Norepinephrine
Corisol
Lead sponsor: Alexandria University
Sponsor class: OTHER
First posted: 2024-10-08
Enrollment: 30
Sex: ALL
Minimum age (years): 3
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim of this randomized trial is to determine efficacy of dexmedetomidine in improving quality of recovery in pediatric patients undergoing interventional catheter closure of ASD while maintaining the hemodynamic parameters. Additionally he stress reducing effects of dexmedetomidine will be investigated in this population .

The main questions it aims to answer are:

Does Dexmedetomidine maintain stable hemodynamics in pediatric patients undergoing transcatheter ASD Closure while improving their quality of recovery?

Does dexmedetomidine prolong duration of recovery and time to extubation in pediatric patients ?

Does dexmedetomidine exert stress reducing properties in this population?

Participants will:

Either be administered Dexmedetomidine in a loading/maintenance regimen or a placebo, with hemodynamics being monitored at the baseline, intraoperatively and postoperatively, with recovery time and quality of recovery especially emergence delirium being monitored. Stress hormone levels will be sampled at baseline and postoperatively.

Detailed description: Atrial Septal Defect (ASD) is one of the most common congenital anomalies in pediatric and even in adult population, it is associated with a left-to-right shunt resulting in right ventricular (RV) volume overload and increase in pulmonary blood flow eventually culmination in right ventricular heart failure (RVHF) and pulmonary hypertension.

Percutaneous closure of ASD was devised nearly a half century ago, and now constitutes a viable alternative to the standard approach of surgical closure. Anesthesia for pediatric patients undergoing percutaneous closure involves a spectrum from sedation to general anesthesia using a variety of drugs according to institutional protocol.

Stress response represents the sum of metabolic nd hormonal perturbations initiated by the hypothalamo-pituitary-adrenal axis in response to the surgical stimulus.

Dexmedetomidine is an α2-adrenoreceptor agonist possessing stress ameliorating effects exerted on the central sympathetic outflow. It can be used either alone in sedation or as supplementation to general anesthesia. It possesses a remarkable hemodynamic stability profile and due to its prolonged duration of action, it plays a significant role in reducing emergence delirium.

This study aims at evaluating utility of dexmedetomidine as a supplementary agent to general anesthesia on hemodynamic stability / cardiac output, reduction of pediatric emergence delirium and stress hormone levels in pediatric patients undergoing transcatheter closure of ASD.

Eligibility criteria: Inclusion Criteria:

* Pediatric Patients 3-12 years of age admitted for device closure of ASD secundum

Exclusion Criteria:

* ASA IV, V
* Neurological problems (cerebral palsy, mental retardation, etc.,)
* Children with chromosomal abnormalities or other multiple congenital anomalies or other complex cardiac anomalies
* Hepatic or renal insufficiency
* History of allergy to the drugs used
* Previous Cardiac Surgery

Primary outcomes:
measure: Hemodynamic Parameters - Cardiac Output
timeFrame: Baseline , Perioperatively
measure: Hemodynamic Parameters - Heart Rate
timeFrame: Baseline , Perioperatively
measure: Hemodynamic Parameters - Mean Arterial Blood Pressure
timeFrame: Baseline , Perioperatively
Secondary outcomes:
measure: Quality of Recovery
timeFrame: Perioperatively
measure: G. Recovery Time
timeFrame: Perioperatively
measure: Time to extubation
timeFrame: Perioperatively
measure: Stress Hormones
timeFrame: Baseline , Perioperatively
measure: Stress Hormones
timeFrame: Baseline , Perioperatively
measure: Side Effects
timeFrame: Perioperatively
Other outcomes:
Locations:
city: Alexandria
country: Egypt
facility: Alexandria University Hospitals - Semouha
Study officials:
References: