Anaesthetic and Pediatric Living Related Liver Transplantation

Not Applicable

• Conditions: Children; Liver Transplantation
• Interventions: Drug: Sevoflurane; Drug: Propofol

• Registration Number: NCT03024840
• Lead Sponsor: Tianjin First Central Hospital

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 Timeline

• Study Start: 2016-12
• Study First Submitted: 2016-12-23
• Status Verified: 2017-01
• Study First Submitted QC: 2017-01-15
• Last Update Submitted: 2017-01-15
• Study First Posted: 2017-01-19
• Last Update Posted: 2017-01-19
• Primary Completion: 2017-05
• Study Completion: 2017-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

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

Exclusion Criteria

• pre-existing cerebral disease second liver transplantation

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
sevoflurane	Sevoflurane	Sevoflurane is inhalated with 1%-2% after anesthesia induction until end of the surgery.
propofol	Propofol	Propofol is injected with 9-15 mg/kg/h after anesthesia induction until end of the surgery.

Primary Outcome Measures

Name	Time	Method
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
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

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

No.24 Fukang Road,Nankai District; 🇨🇳 Tianjin, Tianjin, China