Clinical trial NCT03024840: Anaesthetic and Pediatric Living Related Liver Transplantation
Official title: The Effect of Sevoflurane or Propofol on Brain Injury and Neurocognitive in Pediatric Living Related Liver Transplantation
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Liver Transplantation
Children
Keywords: Propofol
Neurocognitive Disorders
Liver transplantation
Pediatrics
Brain Injuries
Lead sponsor: Tianjin First Central Hospital
Sponsor class: OTHER
First posted: 2017-01-19
Enrollment: 60
Sex: ALL
Minimum age (years): 4
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: To study the effect of different anaesthetic methods on pediatric neurocognitive development and cerebral injury during pediatric living related liver transplantation .

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* Children with end-stage liver disease Children with biliary atresia

Exclusion Criteria:

* pre-existing cerebral disease second liver transplantation

Primary outcomes:
measure: Evidence of cerebral injury including S-100 β protein, neurospecific enolase confirmed by electrochemiluminescence
timeFrame: before skin incision, 0.5 hour after anhepatic,1 hour of neohepatic stage,the end of surgery,24 hours after operation
measure: Evidences of inflammatory factor such as interleukin-6，interleukin-10，et al confirmed by electrochemiluminescence
timeFrame: before skin incision, 0.5 hour after anhepatic,1 hour of neohepatic stage,the end of surgery,24 hours after operation
Secondary outcomes:
measure: Evaluation of neurocognitive disorder using Bayley Scales of Infant Development
timeFrame: 1 day before surgery, 7days,14 days and 21days of post-operation
measure: Evaluation of delirium using Pediatric Anesthesia Emergence Delirium
timeFrame: Within 1 days after extubation
measure: hemodynamics index
timeFrame: before skin incision, 0.5 hour after anhepatic,1 hour of neohepatic stage,the end of surgery,24 hours after operation
Other outcomes:
Locations:
city: Tianjin
country: China
facility: No.24 Fukang Road,Nankai District
state: Tianjin
Study officials:
References: