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

ConditionsAtrial Septal Defect (ASD)DexmedetomidineDelirium - PostoperativeStress Response
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

This trial does not accept healthy volunteers

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

Design model

Parallel

Treatments tested in this trial

  • 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)

Treatment groups

30 Participants
are divided into 2 treatment groups
Group A: Group GDActive comparator 1 intervention
Group B: Group GSPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

Hemodynamic Parameters - Cardiac Output

Cardiac Output/Cardiac index assessed via VTI derived Stroke volume

Time frame
Baseline , Perioperatively
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

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
2

G. Recovery Time

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

Time frame
Perioperatively
3

Time to extubation

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

Time frame
Perioperatively
4

Stress Hormones

Norepinephrine level

Time frame
Baseline , Perioperatively

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Alexandria University

Lead sponsor

Source ClinicalTrials.gov
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