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NCT Number: NCT06631534

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

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.

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • 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

Treatment and study plan

Dexmedetomidine

Drug

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

Saline (NaCl 0,9 %) (placebo)

Drug

Saline (placebo)

Primary outcomes

  1. Hemodynamic Parameters - Cardiac Output

    Time frame: Baseline , Perioperatively

    Cardiac Output/Cardiac index assessed via VTI derived Stroke volume

  2. Hemodynamic Parameters - Heart Rate

    Time frame: Baseline , Perioperatively

  3. Hemodynamic Parameters - Mean Arterial Blood Pressure

    Time frame: Baseline , Perioperatively

Secondary outcomes

  1. Quality of Recovery

    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

  2. G. Recovery Time

    Time frame: Perioperatively

    The time from application of groin bandage to reach a modified Steward score of ≥ 6

  3. Time to extubation

    Time frame: Perioperatively

    Time from applying of groin bandage and cessation of anaesthetic, to removal of ETT

  4. Stress Hormones

    Time frame: Baseline , Perioperatively

    Norepinephrine level

  5. Stress Hormones

    Time frame: Baseline , Perioperatively

    Cortisol Level

  6. Side Effects

    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

Study contacts

Contact information is provided by the study sponsor or research team.

Mohamed Okasha, Specialist - MSc

CONTACT

[email protected]

0201006462352

Sponsors and collaborators

Lead sponsor

Alexandria University

Other

Registry information

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Oct 8, 2024
Registry last updated
Oct 15, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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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