Dexmedetomidine for Congenital Heart Disease

Age: < 18

Sex: Any

Trial Phase: Phase 2

Sponsor: Aymen N Naguib

Disqualifiers: Pulmonary hypertension, HLHS, others

Prior Safety Data This treatment has passed at least one previous human trial

Approved in 4 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

Duration: Immediate perioperative period

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests how the drug dexmedetomidine (also known as Precedex) can help manage anesthesia in children undergoing heart surgery, specifically those with conditions like ASD (a hole in the heart wall) or TOF (a heart defect affecting blood flow), among others. Researchers aim to reduce stress during surgery and improve both immediate and long-term recovery. The trial compares dexmedetomidine with a placebo to determine which is more effective. Children with conditions like ASD or VSD (another heart defect) who require surgery might be suitable candidates. As a Phase 2 trial, this research focuses on evaluating the treatment's effectiveness in an initial, smaller group of participants.

Will I have to stop taking my current medications?

The trial information does not specify whether participants need to stop taking their current medications.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that dexmedetomidine is generally safe for children with heart conditions. One study found that it caused few side effects in infants undergoing heart surgery. Another study indicated it helps maintain steady blood flow during surgery, which is crucial for heart patients. Although a serious issue was reported in a 12-year-old, such cases remain rare. Dexmedetomidine also reduces the need for other pain and anxiety medications, offering additional benefits. Overall, dexmedetomidine appears well-tolerated in children with heart problems. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Dexmedetomidine is unique because it offers a different approach to managing symptoms in congenital heart disease. While most treatments rely heavily on opioids like fentanyl for sedation and pain management, dexmedetomidine acts on alpha-2 adrenergic receptors, providing sedation with less respiratory depression. This means it could potentially reduce the need for high doses of opioids and their associated side effects. Researchers are excited about dexmedetomidine because it might enhance patient comfort and safety, offering a new option that aligns with the goal of minimizing opioid use in vulnerable pediatric patients.

What evidence suggests that dexmedetomidine might be an effective treatment for congenital heart disease?

In this trial, some participants will receive dexmedetomidine, which research has shown to be beneficial for children undergoing heart surgery. It helps maintain steady heart function during the operation. Studies also indicate it can lower the risk of death within 30 days and one year post-surgery. Additionally, dexmedetomidine may reduce the chance of irregular heartbeats after surgery. It is safe for pre-surgery use to calm children with congenital heart disease. These findings suggest dexmedetomidine could improve outcomes for children undergoing heart surgery. ^{3 4 6 7 8}

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

I have been diagnosed with Autism Spectrum Disorder (ASD).

I have had heart surgery to correct a defect with a left to right blood flow issue.

I have been diagnosed with atrioventricular septal defect (AVSD).

Exclusion Criteria

I have AVSD and high blood pressure in my lungs.

My child needs heart surgery for a serious condition and is under 1 year old.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Children undergo cardiac surgery utilizing CPB with anesthetic management to diminish stress response

Immediate perioperative period

In-hospital stay for surgery and recovery

Postoperative Monitoring

Monitoring of cytokine and hormone levels from baseline to 24 hours post-op

24 hours

Neurodevelopmental Follow-up

Assessment of neurodevelopmental progress at discharge, 1-3 months, 6 months, and 1 year post-op

1 year

Multiple visits for neurodevelopmental assessment

Long-term Follow-up

Long-term neurodevelopmental outcome assessment when children reach school age

What Are the Treatments Tested in This Trial?

Interventions

• Dexmedetomidine
• Placebo

Trial Overview 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.

How Is the Trial Designed?

Group I: Dexmedetomidine Experimental Treatment 1 Intervention

Dexmedetomidine in addition to 15 µg/kg of fentanyl

Group II: Placebo Placebo Group 1 Intervention

Normal saline as a placebo in addition to 15 µg/kg of fentanyl

Dexmedetomidine is already approved in European Union, United States, Canada, Japan for the following indications:

Approved in European Union as Precedex for:

• Sedation in intensive care settings
• Procedural sedation

Approved in United States as Precedex for:

• Sedation in intensive care settings
• Procedural sedation

Approved in Canada as Precedex for:

• Sedation in intensive care settings
• Procedural sedation

Approved in Japan as Precedex for:

• Sedation in intensive care settings
• Procedural sedation

Who Is Running the Clinical Trial?

Aymen N Naguib

Lead Sponsor

Trials

5

Recruited

220+

Published Research Related to This Trial

In a study involving 91 pediatric patients, dexmedetomidine was found to be a well-tolerated alternative sedative for non-intubated moderate or deep sedation, with a low incidence of serious adverse events.

While respiratory depression and hypotension were the most common treatment-emergent adverse events, they were manageable and consistent with dexmedetomidine's known safety profile, indicating its potential for safe use in children during elective procedures.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Phase IV, Open-Label, Safety Study Evaluating the Use of Dexmedetomidine in Pediatric Patients Undergoing Procedure-Type Sedation. Jooste, EH., Hammer, GB., Reyes, CR., et al.[2020]

Dexmedetomidine is commonly used as a safe sedative during surgeries, but there are rare cases where it can lead to serious complications, such as cardiac arrest.

In this report, a 76-year-old woman experienced cardiac arrest during a pacemaker lead extraction procedure while being treated with dexmedetomidine, highlighting the need for careful monitoring in older patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Dexmedetomidine related cardiac arrest in a patient with permanent pacemaker; a cautionary tale. Shah, AN., Koneru, J., Nicoara, A., et al.[2013]

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/35779302/

Preoperative sedation in children with congenital heart ... Intranasal dexmedetomidine can be safety used for preoperative sedation in children with CHD and is effective for sedation when dosed appropriately.

2. sciencedirect.com sciencedirect.com/science/article/pii/S0021755721000917

Efficacy and safety of dexmedetomidine in maintaining ... This study aims to investigate the effectiveness and adverse events of DEX in maintaining hemodynamic stability in pediatric cardiac surgery.

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11273103/

Intraoperative Dexmedetomidine Improves the Outcome of ... Conclusions: Dexmedetomidine administered intraoperatively reduced 30-day and 1-year mortality in children undergoing pediatric cardiac surgery. Keywords: ...

4. ahajournals.org ahajournals.org/doi/10.1161/circep.114.002301

Association Between Perioperative Dexmedetomidine and ... Previous studies have suggested that postoperative dexmedetomidine use may decrease the incidence of tachyarrhythmias after congenital heart ...

5. imrpress.com imrpress.com/journal/RCM/24/10/10.31083/j.rcm2410289/pdf

Intraoperative Dexmedetomidine Improves the Outcome of ... Conclusions: Dexmedetomidine administered intraoperatively reduced 30-day and 1-year mortality in children undergoing pediatric cardiac surgery.

6. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/22791093/

Safety and efficacy of prolonged dexmedetomidine use in ... Prolonged dexmedetomidine administration in children with heart disease appears to be safe and is associated with decreased opioid and benzodiazepine ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6993105/

Results of a phase 1 multicentre investigation of ... DEX results in low incidence and severity of adverse safety events in infants undergoing cardiac surgery with cardiopulmonary bypass.

8. fda.gov fda.gov/files/advisory%20committees/published/PRECEDEX-Safety-and-Drug-Utilization-Review.pdf

Precedex (dexmedetomidine) Safety and Drug Utilization ... congenital heart disease (Shepard lit), other anesthetics (Bharati lit)]. One of these cases (cardiac arrest in a 12 year-old) had a pre ...