Dexmedetomidine Neuroprotection in Pediatric Cardiac Surgery

Seoul National University

Status: Unknown

Conditions: Congenital Heart Disease

Treatments: Drug: Normal saline; Drug: Dexmedetomidine

Study type: Interventional

Funder types: Other

Identifiers

NCT04484922

2001-062-1095

Details and patient eligibility

About

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.

Enrollment: 160 estimated patients

Sex: All

Ages: Under 1 year old

Volunteers: No Healthy Volunteers

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)
• 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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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160 participants in 2 patient groups, including a placebo group

Dexmedetomidine

Experimental group

Treatment:

Drug: Dexmedetomidine

Control

Placebo Comparator group

Treatment:

Drug: Normal saline