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Alpha-2 Adrenergic Agonist

Dexmedetomidine for Congenital Heart Disease

Phase 2
Waitlist Available
Research Sponsored by Aymen N Naguib
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Patients with the diagnosis of ASD
Patients with biventricular repair with left to right shunt
Must not have
Patients with the diagnosis of AVSD and pulmonary hypertension
Patients less than 1 year and require any of the following repairs: HLHS, Aortic arch reconstruction, Arterial switch, TOF with pulmonary atresia
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from baseline to 1 year post-op

Summary

This trial is testing whether different anesthetics can help reduce stress and improve outcomes for children undergoing heart surgery.

Who is the study for?
This trial is for children with certain heart conditions (like VSD, TOF without pulmonary atresia, ASD, and AVSD) who are undergoing cardiac surgery with CPB. It's not for kids under 1 year or those needing specific surgeries like HLHS repair or arterial switch, nor for AVSD patients with pulmonary hypertension.
What is being tested?
The study tests whether Dexmedetomidine can reduce stress and protect the brain during heart surgery in kids compared to a placebo. Researchers will measure stress markers and cerebral injury biomarkers to see if there's an improvement in immediate postoperative outcomes and long-term neurodevelopment.
What are the potential side effects?
Dexmedetomidine may cause side effects such as low blood pressure, slow heart rate, dry mouth, nausea. Since it's used here to manage anesthesia during surgery, monitoring will be strict to manage any potential side effects.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have been diagnosed with Autism Spectrum Disorder (ASD).
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I have had heart surgery to correct a defect with a left to right blood flow issue.
Select...
I have been diagnosed with atrioventricular septal defect (AVSD).
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I have been diagnosed with a ventricular septal defect (VSD).
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I have been diagnosed with Tetralogy of Fallot (TOF).

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
I have AVSD and high blood pressure in my lungs.
Select...
My child needs heart surgery for a serious condition and is under 1 year old.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from baseline to 1 year post-op
This trial's timeline: 3 weeks for screening, Varies for treatment, and from baseline to 1 year post-op for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Change in cytokine levels
Change in hormone levels
Change in neurodevelopmental scores

Side effects data

From 2020 Phase 4 trial • 798 Patients • NCT02004613
57%
Clinically important hypotension
9%
Clinically important bradycardia
1%
infection
1%
stroke
1%
Atelectasis
1%
Hemorrhage
100%
80%
60%
40%
20%
0%
Study treatment Arm
Placebo
Dexmedetomidine

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: DexmedetomidineExperimental Treatment1 Intervention
Dexmedetomidine in addition to 15 µg/kg of fentanyl
Group II: PlaceboPlacebo Group1 Intervention
Normal saline as a placebo in addition to 15 µg/kg of fentanyl
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Dexmedetomidine
2015
Completed Phase 4
~2050

Find a Location

Who is running the clinical trial?

Aymen N NaguibLead Sponsor
4 Previous Clinical Trials
186 Total Patients Enrolled

Media Library

Dexmedetomidine (Alpha-2 Adrenergic Agonist) Clinical Trial Eligibility Overview. Trial Name: NCT02492269 — Phase 2
Congenital Heart Disease Research Study Groups: Dexmedetomidine, Placebo
Congenital Heart Disease Clinical Trial 2023: Dexmedetomidine Highlights & Side Effects. Trial Name: NCT02492269 — Phase 2
Dexmedetomidine (Alpha-2 Adrenergic Agonist) 2023 Treatment Timeline for Medical Study. Trial Name: NCT02492269 — Phase 2
~2 spots leftby Dec 2025
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