Effect of Dexmedetomidine Supplementation to General Anaesthesia in Paediatric Transcatheter Closure of Atrial Septal Defect
Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age3-12
SponsorAlexandria University
About this trial
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 criteria
Qualifiers
Pediatric Patients 3-12 years of age admitted for device closure of ASD secundum
Disqualifiers
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
Trial design
Treatments tested in this trial
- Dexmedetomidine
- Saline (NaCl 0,9 %) (placebo)
Treatment groups
30 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov