RecruitingPhase 4NCT06631534

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


Sponsor

Alexandria University

Enrollment

30 participants

Start Date

Apr 3, 2024

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 3 YearsMax Age: 12 Years

Inclusion Criteria1

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

Exclusion Criteria6

  • 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

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Interventions

DRUGDexmedetomidine

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

DRUGSaline (NaCl 0,9 %) (placebo)

Saline (placebo)


Locations(1)

Alexandria University Hospitals - Semouha

Alexandria, Alexandria Governorate, Egypt

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NCT06631534


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