The Effect of Dexmedetomidine on Neuroprotection in Pediatric Cardiac Surgery Patients: a Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 入组人数
- 160
- 试验地点
- 1
- 主要终点
- Bayley scales of Infant development
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- — 至 1 Year（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Neonates undergoing cardiac surgery
- •Infants undergoing cardiac surgery with cardiopulmonary bypass (atrial septal defect repair, ventricular septal defect repair, or tetralogy of fallot repair)
排除标准
- •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
研究组 & 干预措施
Dexmedetomidine
干预措施: Dexmedetomidine (Drug)
Control
干预措施: Normal saline (Drug)
结局指标
主要结局
Bayley scales of Infant development
时间窗: 1 year after the surgery
Developmental outcomes at each assessment and within each domain (cognitive, language, and motor) were classified as "average" if they were within 1 SD of the mean or higher (scores .85), "at risk" if they were 1 to 2 SD below the mean (scores 70-84), and "delayed" if they were .2SD below the mean (,70). The trajectory of development over time in each domain (cognitive, language, and motor)
次要结局
- neurodevelopment biomarker(intraoperative (before skin incision, end of hypothermia, end of cardiopulmonary bypass), 4 hours after end of surgery)
- inflammation(4 hours after end of surgery)
- acute kidney injury(2 hours after end of cardiopulmonary bypass)
- fluid management(intraoperative (from anesthetic induction to end of surgery))
- myocardial injury(intraoperative (before skin incision, end of cardiopulmonary bypass), 4 hours after end of surgery, 24 hours after end of surgery)
- anesthesia monitoring(intraoperative (from anesthetic induction to end of surgery))
研究者
Eun-hee Kim
Clinical assistant professor
Seoul National University Hospital