Dexmedetomidine for Congenital Heart Disease

Recruiting in Palo Alto (17 mi)

Age: < 18

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: Aymen N Naguib

Prior Safety Data

Approved in 4 Jurisdictions

Trial Summary

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).

+2 more

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.

Participant Groups

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.

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

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

🇪🇺 Approved in European Union as Precedex for: