Stress Response and Neurodevelopmental Outcome After Cardiac Surgery Utilizing CPB in Children: A Prospective, Double Blinded and Randomized Study
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Change in Hormone Levels
研究概览
简要总结
The overall goal of this project is to determine the role of anesthetic management in children undergoing cardiac surgery utilizing CPB in the setting of fast tracking and early extubation. An ideal anesthetic technique would ensure abolishing or diminishing stress response as would be evident by the stress markers levels and the level of two cerebral injury biomarkers (S 100 B and NSE). This should translate to better immediate postoperative outcome and hopefully improve both the short and the long term neurodevelopmental outcome in these children. The project is prospective, randomized and blinded study. The first and second aim of the study should be conducted over 2 year period. Our long term aim will be concluded when these children reach the school age.
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
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 1 Month 至 12 Months（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with the following diagnosis:
- •Biventricular repair with left to right shunt.
排除标准
- •Patients with the diagnosis of AVSD and pulmonary hypertension
- •Patients less than 1 year and require any of the following repairs:
- •Aortic arch reconstruction
- •Arterial switch
- •TOF with pulmonary atresia
研究组 & 干预措施
Dexmedetomidine
Dexmedetomidine in addition to 15 µg/kg of fentanyl
干预措施: Dexmedetomidine (Drug)
Placebo
Normal saline as a placebo in addition to 15 µg/kg of fentanyl
干预措施: Placebo (Drug)
结局指标
主要结局
Change in Hormone Levels
时间窗: From baseline to 24 hrs post-op
ACTH, cortisol, epinephrine, \& norepinephrine will be measured at induction of anesthesia (baseline), after sternotomy, after initiation of CPB, at the conclusion of surgery (separation from CPB and administration of protamine and prior to skin closure) and at 24 hours post-operatively.
Change in Bayley Cognitive Composite Scores
时间窗: From baseline to 1 year post-op
Children will have a baseline neurodevelopmental Bayley score during the preoperative period. These children will be retested prior to discharge from the hospital, at their post-op cardiology visit (usually 1-3 months post-op), six month and one year postoperatively to evaluate neurodevelopment progress. Mean score of 100 (SD=15) at the 50th percentile signifies mid-average functioning, scores below 85 (1 SD below the mean), at the 16th percentile, indicate mild impairment of being 'at risk' of developmental delay. Score below 70 (2 SD below the mean), at the second percentile, indicate moderate to severe impairment.
Change in Cytokine Levels
时间窗: From baseline to 24 hrs post-op
Cytokine levels in plasma samples will be measured at induction of anesthesia (baseline), after sternotomy, after initiation of CPB, at the conclusion of surgery (separation from CPB and administration of protamine and prior to skin closure) and at 24 hours post-operatively.
次要结局
- Change in Bayley Language Composite Scores(From baseline to 1 year post-op)
- Change in Bayley Motor Composite Scores(From baseline to 1 year post-op)
研究者
Aymen N Naguib
Director of Pediatric Cardiothoracic Anesthesia
Nationwide Children's Hospital