Alexandria University Hospitals - Semouha
Alexandria, Alexandria Governorate, Egypt
Location status: Recruiting
NCT Number: NCT06631534
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.
Interested in participating?
Request Info3 year–12 year
All sexes
Interventional
Phase 4
Alexandria, Alexandria Governorate, Egypt
Location status: Recruiting
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Dexmedetomidine 1ug/kg bolus administered over 10 minutes followed by a continuous infusion of 0.5ug/kg/hr
Saline (placebo)
Time frame: Baseline , Perioperatively
Cardiac Output/Cardiac index assessed via VTI derived Stroke volume
Time frame: Baseline , Perioperatively
Time frame: Baseline , Perioperatively
Time frame: 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
Time frame: Perioperatively
The time from application of groin bandage to reach a modified Steward score of ≥ 6
Time frame: Perioperatively
Time from applying of groin bandage and cessation of anaesthetic, to removal of ETT
Time frame: Baseline , Perioperatively
Norepinephrine level
Time frame: Baseline , Perioperatively
Cortisol Level
Time frame: 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
Contact information is provided by the study sponsor or research team.
Alexandria University
Other
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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