The Effect of Sevoflurane or Propofol on Brain Injury and Neurocognitive in Pediatric Living Related Liver Transplantation
Trial Snapshot
- Phase
- Not Applicable
- Sponsor
- Enrollment
- 60
- Locations
- 1
- Primary Endpoint
- Evidences of inflammatory factor such as interleukin-6，interleukin-10，et al confirmed by electrochemiluminescence
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- Single (Participant)
Eligibility Criteria
- Ages
- 4 Months to 12 Months (Child)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Children with end-stage liver disease Children with biliary atresia
Exclusion Criteria
- •pre-existing cerebral disease second liver transplantation
Arms & Interventions
sevoflurane
Sevoflurane is inhalated with 1%-2% after anesthesia induction until end of the surgery.
Intervention: Sevoflurane (Drug)
propofol
Propofol is injected with 9-15 mg/kg/h after anesthesia induction until end of the surgery.
Intervention: Propofol (Drug)
Outcomes
Primary Outcomes
Evidences of inflammatory factor such as interleukin-6，interleukin-10，et al confirmed by electrochemiluminescence
Time Frame: 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
Time Frame: before skin incision, 0.5 hour after anhepatic,1 hour of neohepatic stage,the end of surgery,24 hours after operation
Secondary Outcomes
- 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)
Investigators
Wenli Yu
Wenli Yu,PhD ,Department of Anesthesiology,Tianjin First Center Hospital
Tianjin First Central Hospital