Anaesthetic and Pediatric Living Related Liver Transplantation

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

Detailed Description
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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.

Official Title
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The Effect of Sevoflurane or Propofol on Brain Injury and Neurocognitive in Pediatric Living Related Liver Transplantation

Conditions
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Liver Transplantation, Children

Intervention / Treatment
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* Drug: Sevoflurane
* Drug: Propofol


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Children with end-stage liver disease Children with biliary atresia Exclusion Criteria: pre-existing cerebral disease second liver transplantation

Ages Eligible for Study
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Minimum Age: 4 Months
Maximum Age: 12 Months

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: sevoflurane<br>Sevoflurane is inhalated with 1%-2% after anesthesia induction until end of the surgery. | Drug: Sevoflurane<br>* Sevoflurane: 1% 2%<br>|
| Experimental: propofol<br>Propofol is injected with 9-15 mg/kg/h after anesthesia induction until end of the surgery. | Drug: Propofol<br>* Propofol: 9-15 mg/kg/h<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evidence of cerebral injury including S-100 β protein, neurospecific enolase confirmed by electrochemiluminescence |  | before skin incision, 0.5 hour after anhepatic,1 hour of neohepatic stage,the end of surgery,24 hours after operation | 
| Evidences of inflammatory factor such as interleukin-6，interleukin-10，et al confirmed by electrochemiluminescence |  | before skin incision, 0.5 hour after anhepatic,1 hour of neohepatic stage,the end of surgery,24 hours after operation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Propofol, Neurocognitive Disorders, Liver transplantation, Pediatrics, Brain Injuries