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

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a drug called Dexmedetomidine and a drug called Saline (NaCl 0,9 %) (placebo) for people with atrial septal defect (asd), delirium - postoperative, and other related conditions. The study is currently recruiting participants at 1 location.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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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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