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

30 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

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

What data supports the effectiveness of the drug Dexmedetomidine for congenital heart disease?

Research shows that Dexmedetomidine can help reduce cardiac complications in children undergoing surgery for congenital heart disease. It is effective for sedation, reducing anxiety, and limiting the need for other anesthetics and pain medications during and after surgery. ^{1 2 3 4 5}

Is dexmedetomidine safe for use in humans, especially in children with congenital heart disease?

Dexmedetomidine is generally considered safe for use in humans, including children, but it can cause some side effects like slow heart rate (bradycardia), low blood pressure (hypotension), and in rare cases, heart issues like cardiac arrest. It has been used safely in many procedures, but caution is advised, especially in patients with heart conditions. ^{2 3 6 7 8}

How is the drug dexmedetomidine unique for treating congenital heart disease?

Dexmedetomidine is unique because it is a sedative that also helps manage heart rate and blood pressure without affecting lung blood vessels, making it suitable for children with congenital heart disease. It is not FDA-approved for children but is used to reduce stress and the need for other anesthetics during surgery. ^{1 2 3 7 9}

What is the purpose of this trial?

The overall goal of this project is to determine the role of anesthetic management in children undergoing cardiac surgery utilizing CPB in the setting of fast tracking and early extubation. An ideal anesthetic technique would ensure abolishing or diminishing stress response as would be evident by the stress markers levels and the level of two cerebral injury biomarkers (S 100 B and NSE). This should translate to better immediate postoperative outcome and hopefully improve both the short and the long term neurodevelopmental outcome in these children. The project is prospective, randomized and blinded study. The first and second aim of the study should be conducted over 2 year period. Our long term aim will be concluded when these children reach the school age.

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

References

1. France pubmed.ncbi.nlm.nih.gov

Outcomes of dexmedetomidine treatment in pediatric patients undergoing congenital heart disease surgery: a meta-analysis. [2018]

2. United States pubmed.ncbi.nlm.nih.gov

Dexmedetomidine: applications for the pediatric patient with congenital heart disease. [2022]

3. United States pubmed.ncbi.nlm.nih.gov

The Perioperative Use of Dexmedetomidine in Pediatric Patients with Congenital Heart Disease: An Analysis from the Congenital Cardiac Anesthesia Society-Society of Thoracic Surgeons Congenital Heart Disease Database. [2022]

4. United States pubmed.ncbi.nlm.nih.gov

A dose-response study of dexmedetomidine administered as the primary sedative in infants following open heart surgery. [2021]

5. United States pubmed.ncbi.nlm.nih.gov

Preoperative sedation in children with congenital heart disease: 50% and 95% effective doses, hemodynamic effects, and safety of intranasal dexmedetomidine. [2022]

6. Switzerland pubmed.ncbi.nlm.nih.gov

Phase IV, Open-Label, Safety Study Evaluating the Use of Dexmedetomidine in Pediatric Patients Undergoing Procedure-Type Sedation. [2020]

7. United States pubmed.ncbi.nlm.nih.gov

Dexmedetomidine related cardiac arrest in a patient with permanent pacemaker; a cautionary tale. [2013]

8. United States pubmed.ncbi.nlm.nih.gov

Characterization of dexmedetomidine dosing and safety in neonates and infants. [2020]

9. Japan pubmed.ncbi.nlm.nih.gov

[The effect of dexmedetomidine in a child with intractable supraventricular tachyarrythmia after total cavopulmonary connection]. [2013]