The Effect of Sevoflurane or Propofol on Brain Injury and Neurocognitive in Pediatric Living Related Liver Transplantation
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Evidences of inflammatory factor such as interleukin-6，interleukin-10，et al confirmed by electrochemiluminescence
研究概览
简要总结
To study the effect of different anaesthetic methods on pediatric neurocognitive development and cerebral injury during pediatric living related liver transplantation .
详细描述
Since the 1960 s, with the successful development of liver transplantation, it has become an important method for the treatment of patients with end-stage liver disease.Biliary atresia1 is the most frequent causes of pediatric end-stage liver disease,.The morbidity of congenital biliary atresia is 1/8000-18, 0002 ,which influence the patients' overall growth and development situation. The rising of living donor liver transplantation has provide children with the chance of a timely treatment since the 1980 s, It is no doubt that pediatric liver transplantation is facing with many complications, including the most importance of neurocognitive development .Now the researches of neurological complications is less .According to statistics, the incidence of neurological complications after pediatric liver transplantation was 8% - 46% . So it is necessary to research the neurological complications and brain protection strategy .Previous studies have studied that some anaesthetic have uncertain affect on the development of children.
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
- Single (Participant)
入排标准
- 年龄范围
- 4 Months 至 12 Months（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Children with end-stage liver disease Children with biliary atresia
排除标准
- •pre-existing cerebral disease second liver transplantation
研究组 & 干预措施
sevoflurane
Sevoflurane is inhalated with 1%-2% after anesthesia induction until end of the surgery.
干预措施: Sevoflurane (Drug)
propofol
Propofol is injected with 9-15 mg/kg/h after anesthesia induction until end of the surgery.
干预措施: Propofol (Drug)
结局指标
主要结局
Evidences of inflammatory factor such as interleukin-6，interleukin-10，et al confirmed by electrochemiluminescence
时间窗: before skin incision, 0.5 hour after anhepatic,1 hour of neohepatic stage,the end of surgery,24 hours after operation
Evidence of cerebral injury including S-100 β protein, neurospecific enolase confirmed by electrochemiluminescence
时间窗: before skin incision, 0.5 hour after anhepatic,1 hour of neohepatic stage,the end of surgery,24 hours after operation
次要结局
- Evaluation of neurocognitive disorder using Bayley Scales of Infant Development(1 day before surgery, 7days,14 days and 21days of post-operation)
- Evaluation of delirium using Pediatric Anesthesia Emergence Delirium(Within 1 days after extubation)
- hemodynamics index(before skin incision, 0.5 hour after anhepatic,1 hour of neohepatic stage,the end of surgery,24 hours after operation)
研究者
Wenli Yu
Wenli Yu,PhD ,Department of Anesthesiology,Tianjin First Center Hospital
Tianjin First Central Hospital