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

October 10, 2024 updated by: Mohamed Ahmed Adel Okasha, Alexandria University

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Estimated)

30

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Egypt
      • Alexandria, Egypt
        • Recruiting
        • Alexandria University Hospitals - Semouha
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Group GD
Anesthesia induction and maintenance with sevoflurane inhalational anesthesia in addition dexmedetomidine diluted in normal saline (NS) to a concentration of 4ug/ml (in a 50 ml syringe) bolus dose will be administered through the IV catheter at 1 ug/kg over 10 minutes, followed by an infusion rate of dexmedetomidine 0.5ug/kg/hr with use of a syringe pump.
Drug: Dexmedetomidine
Dexmedetomidine 1ug/kg bolus administered over 10 minutes followed by a continuous infusion of 0.5ug/kg/hr
Placebo Comparator: Group GS
Anaesthesia induction and maintenance with sevoflurane inhalational anaesthesia in addition a 50 ml syringe admisinstered at the same initial rate and maintenance rate as would a vloume-matched dexmedetomidine syringe. Syringes will be prepared by an independent party.
Drug: Saline (NaCl 0,9 %) (placebo)
Saline (placebo)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Hemodynamic Parameters - Cardiac Output
Time Frame: Baseline , Perioperatively
Cardiac Output/Cardiac index assessed via VTI derived Stroke volume
Baseline , Perioperatively
Hemodynamic Parameters - Heart Rate
Time Frame: Baseline , Perioperatively
Baseline , Perioperatively
Hemodynamic Parameters - Mean Arterial Blood Pressure
Time Frame: Baseline , Perioperatively
Baseline , Perioperatively

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Perioperatively
G. Recovery Time
Time Frame: Perioperatively
The time from application of groin bandage to reach a modified Steward score of ≥ 6
Perioperatively
Time to extubation
Time Frame: Perioperatively
Time from applying of groin bandage and cessation of anaesthetic, to removal of ETT
Perioperatively
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
Perioperatively
Stress Hormones
Time Frame: Baseline , Perioperatively
Norepinephrine level
Baseline , Perioperatively
Stress Hormones
Time Frame: Baseline , Perioperatively
Cortisol Level
Baseline , Perioperatively

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Alexandria University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 3, 2024

Primary Completion (Estimated)

December 1, 2024

Study Completion (Estimated)

December 1, 2024

Study Registration Dates

First Submitted

September 25, 2024

First Submitted That Met QC Criteria

October 7, 2024

First Posted (Actual)

October 8, 2024

Study Record Updates

Last Update Posted (Actual)

October 15, 2024

Last Update Submitted That Met QC Criteria

October 10, 2024

Last Verified

October 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 0201930

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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