DEX vs SEVO in Congenital Heart Surgery

Launched by CLINIQUES UNIVERSITAIRES SAINT-LUC- UNIVERSITÉ CATHOLIQUE DE LOUVAIN · May 6, 2022

Keywords

ClinConnect Summary

This clinical trial is investigating the effects of two different anesthetics, dexmedetomidine (DEX) and sevoflurane, on young children undergoing heart surgery. Researchers want to find out if using DEX alongside a low dose of sevoflurane can help protect the brains of children with congenital heart defects from potential injury during surgery. This is important because many children with these heart defects show developmental challenges later in life. The study will measure specific markers in the blood that indicate brain injury and assess the children’s brain activity and development after surgery.

To be eligible for this trial, children must be between 0 and 3 years old and need to have heart surgery that involves a heart-lung machine. However, children with certain health conditions, like severe kidney problems, active brain bleeding, or specific genetic disorders, will not be able to participate. Families who choose to enroll their child in this study can expect thorough monitoring during surgery and follow-up assessments to track their child’s recovery and development. Overall, this research aims to better understand how to protect the brains of young patients during critical heart surgeries.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Patients up to 3 years
• • Must undergo cardiac surgery with CPB
• Exclusion Criteria:
• • Preoperative chronic kidney disease (glomerular filtration rate of less than 30 ml/min per 1.73m2 for greater than 3 months)
• • Preoperative cerebral hemorrhage, stroke or
• • Preoperative seizures
• • Abnormal preoperative cerebral ultrasound
• • Preoperative Extracorporeal Life Support
• • Preoperative sedated and intubated patients
• • Preterm newborns (\< 32 W gestational age)
• • Newborns weighing \< 2 kg
• • Patients with Williams-Beuren syndrome.