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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from baseline to 1 year post-op
Awards & highlights

Study 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.Check my eligibility
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.See study design
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.
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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).

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
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
~1980

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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Does this test only consider young adults?

"This clinical trial includes infants that are one month old up to 12 months old."

Answered by AI

How many people have been chosen to participate in this clinical trial?

"This particular study is no longer recruiting patients, with the most recent update having been on February 9th, 2022. However, there are 361 other trials for heart defects and 118 for Dexmedetomidine that are still looking for volunteers."

Answered by AI

Are there any slots left for potential participants in this experiment?

"This particular trial, which was published on May 1st 2014 and updated February 9th 2022, is not currently looking for new patients. It's worth noting that 479 other studies are actively recruiting participants."

Answered by AI

Has the FDA greenlit Dexmedetomidine for public consumption?

"Given that this is a phase 2 trial (meaning there is some data supporting safety but none supporting efficacy), our team at Power have given Dexmedetomidine a score of 2 for safety."

Answered by AI

Is there a body of research to support the use of Dexmedetomidine?

"This medication is being studied in 118 ongoing clinical trials, with 25 of them being in the third and final stage. Most of these trials are taking place in Karachi, Sindh; however, there are 222 locations total running Dexmedetomidine studies."

Answered by AI

To what extent is Dexmedetomidine effective?

"Originally designed as a treatment for disorders, dexmedetomidine is also used to help patients who require ventilation, have intubation issues, or suffer from cyclic vomiting syndrome."

Answered by AI

How can I sign up to help with this research?

"Investigators are looking to enroll 30 infants that have had congenital heart defects repaired with a left-to-right shunt. The patients must be between 1 month and 12 months old to participate."

Answered by AI
~4 spots leftby Dec 2025