Status:
UNKNOWN
Dexmedetomidine Neuroprotection in Pediatric Cardiac Surgery
Lead Sponsor:
Seoul National University Hospital
Conditions:
Congenital Heart Disease
Eligibility:
All Genders
Up to 1 years
Phase:
NA
Brief Summary
Neurodevelopmental disability is the most significant complication for survivors of infant surgery for congenital heart disease. In this study we sought to determine if intraoperative continuous infus...
Eligibility Criteria
Inclusion
- Neonates undergoing cardiac surgery
- Infants undergoing cardiac surgery with cardiopulmonary bypass (atrial septal defect repair, ventricular septal defect repair, or tetralogy of fallot repair)
Exclusion
- History of hypersensitivity of any drug
- Presence of hypotension or bradycardia considering age Bradycardia (heart rate \< 80 beats/min) or hypotension (systolic blood pressure \< 70mmHg for infants, \< 60mmHg for neonates)
- Elevated liver enzyme levels (aspartate transaminase \>100unit/L, alanine aminostrasferase \> 50 unit/L)
- surgery with deep hypothermic circulatory arrest
- Presence of complex cardiac defect
- single ventricular physiology
- plan of additional operation within a year
- preoperative use of beta-agonists
- presence of history of any neurological disorder
Key Trial Info
Start Date :
August 25 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
May 31 2023
Estimated Enrollment :
160 Patients enrolled
Trial Details
Trial ID
NCT04484922
Start Date
August 25 2020
End Date
May 31 2023
Last Update
February 2 2022
Active Locations (1)
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1
Seoul national university hospital
Seoul, South Korea