Dexmedetomidine Neuroprotection in Pediatric Cardiac Surgery

  • STATUS
    Recruiting
  • End date
    May 31, 2023
  • participants needed
    160
  • sponsor
    Seoul National University Hospital
Updated on 25 March 2022

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 infusion of dexmedetomidine are associated with neurodevelopmental outcomes at 12 months.

Details
Condition Congenital Heart Disease
Treatment Dexmedetomidine, Normal saline
Clinical Study IdentifierNCT04484922
SponsorSeoul National University Hospital
Last Modified on25 March 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

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 Criteria

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)
surgery with deep hypothermic circulatory arrest
Elevated liver enzyme levels (aspartate transaminase >100unit/L, alanine aminostrasferase > 50 unit/L)
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
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