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

NCT06631534 | Recruiting Phase 4

• 1 other identifier: 0201930
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Atrial Septal Defect (ASD); Dexmedetomidine; Delirium - Postoperative; Stress Response

Keywords

Atrial septal Defect; ASD; Dexmedetomidine; Echocardiography; Cardiac index; PAED; VTI; Norepinephrine; Corisol

Outcome Measures

Primary Outcomes (3)

• Hemodynamic Parameters - Cardiac Output

  Cardiac Output/Cardiac index assessed via VTI derived Stroke volume

  Baseline , Perioperatively

• Hemodynamic Parameters - Heart Rate

  Baseline , Perioperatively

• Hemodynamic Parameters - Mean Arterial Blood Pressure

  Baseline , Perioperatively

Secondary Outcomes (6)

• Quality of Recovery

  Perioperatively

• G. Recovery Time

  Perioperatively

• Time to extubation

  Perioperatively

• Stress Hormones

  Baseline , Perioperatively

• Stress Hormones

  Baseline , Perioperatively

Study Arms (2)

Group GD

ACTIVE COMPARATOR

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.

Drug: Dexmedetomidine

Group GS

PLACEBO COMPARATOR

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.

Drug: Saline (NaCl 0,9 %) (placebo)

Interventions

Dexmedetomidine DRUG

Dexmedetomidine 1ug/kg bolus administered over 10 minutes followed by a continuous infusion of 0.5ug/kg/hr

Group GD

Saline (NaCl 0,9 %) (placebo) DRUG

Saline (placebo)

Group GS

Eligibility Criteria

• Age: 3 Years - 12 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Alexandria University: lead

Study Sites (1)

Alexandria University Hospitals - Semouha

Alexandria, Alexandria Governorate, Egypt

RECRUITING

MeSH Terms

Conditions

Heart Septal Defects, Atrial; Emergence Delirium; Fractures, Stress

Interventions

Dexmedetomidine; Sodium Chloride

Condition Hierarchy (Ancestors)

Heart Septal Defects; Heart Defects, Congenital; Cardiovascular Abnormalities; Cardiovascular Diseases; Heart Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Delirium; Confusion; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Neurocognitive Disorders; Mental Disorders; Fractures, Bone; Wounds and Injuries

Intervention Hierarchy (Ancestors)

Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Central Study Contacts

Mohamed Okasha, Specialist - MSc

CONTACT

0201006462352; m_adel13@alexmed.edu.eg

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Lecturer

Study Record Dates

• First Submitted: September 25, 2024
• First Posted: October 8, 2024
• Study Start: April 3, 2024
• Primary Completion: December 1, 2024
• Study Completion: December 1, 2024
• Last Updated: October 15, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)