Effect of Dexmedetomidine Supplementation to General Anaesthesia in Paediatric Transcatheter Closure of Atrial Septal Defect

Phase 4

Recruiting

• Conditions: Atrial Septal Defect (ASD); Dexmedetomidine; Delirium - Postoperative; Stress Response
• Interventions: Drug: Dexmedetomidine; Drug: Saline (NaCl 0,9 %) (placebo)

• Registration Number: NCT06631534
• Lead Sponsor: Alexandria University

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.

Study Timeline

• Study Start: 2024-04-03
• Study First Submitted: 2024-09-25
• Status Verified: 2024-10
• Study First Submitted QC: 2024-10-07
• Study First Posted: 2024-10-08
• Last Update Submitted: 2024-10-10
• Last Update Posted: 2024-10-14
• Primary Completion: 2024-12
• Study Completion: 2024-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 30

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group GD	Dexmedetomidine	Anesthesia induction and maintenance with sevoflurane inhalational anesthesia in addition dexmedetomidine diluted in normal saline (NS) to a concentration of 4ug/ml (in a 50 ml syringe) bolus dose will be administered through the IV catheter at 1 ug/kg over 10 minutes, followed by an infusion rate of dexmedetomidine 0.5ug/kg/hr with use of a syringe pump.
Group GS	Saline (NaCl 0,9 %) (placebo)	Anaesthesia induction and maintenance with sevoflurane inhalational anaesthesia in addition a 50 ml syringe admisinstered at the same initial rate and maintenance rate as would a vloume-matched dexmedetomidine syringe. Syringes will be prepared by an independent party.

Primary Outcome Measures

Name	Time	Method
Hemodynamic Parameters - Cardiac Output	Baseline , Perioperatively	Cardiac Output/Cardiac index assessed via VTI derived Stroke volume
Hemodynamic Parameters - Heart Rate	Baseline , Perioperatively
Hemodynamic Parameters - Mean Arterial Blood Pressure	Baseline , Perioperatively

Secondary Outcome Measures

Name	Time	Method
Quality of Recovery	Perioperatively	Quality of recovery will be assessed in paediatric ICU using the paediatric anaesthesia emergence delirium (PAED) scores every 5 minutes after awakening for 30 minutes
G. Recovery Time	Perioperatively	The time from application of groin bandage to reach a modified Steward score of ≥ 6
Time to extubation	Perioperatively	Time from applying of groin bandage and cessation of anaesthetic, to removal of ETT
Stress Hormones	Baseline , Perioperatively	Cortisol Level
Side Effects	Perioperatively	Clinically significant Bradycardia: HR less than 60 or decrease 30% Clinically significant Tachycardia: HR increase 30% Clinically significant Hypotension: MAP decrease 30% Clinically significant Hypertension: MAP increase 30% Nausea and vomiting

Trial Locations

Locations (1)

Alexandria University Hospitals - Semouha; 🇪🇬 Alexandria, Egypt