Anaesthetic and Pediatric Living Related Liver Transplantation

Liver Transplantation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT03024840
• Other study ID #: 2016N0039KY
• Status: Enrolling by invitation
• Phase: N/A
• First received: December 23, 2016
• Last updated: January 15, 2017
• Start date: December 2016
• Est. completion date: December 2017

Study information

• Verified date: January 2017
• Source: Tianjin First Central Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 60
• Est. completion date: December 2017
• Est. primary completion date: May 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 4 Months to 12 Months

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

• pre-existing cerebral disease second liver transplantation

Related Conditions & MeSH terms

• Children
• Liver Transplantation

Intervention

Drug:
• Sevoflurane
Sevoflurane: 1%~2%
• Propofol
Propofol: 9-15 mg/kg/h

Locations

Country	Name	City	State
China	No.24 Fukang Road,Nankai District	Tianjin	Tianjin

Sponsors (1)

Lead Sponsor	Collaborator
Tianjin First Central Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Evidence of cerebral injury including S-100 ß 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
Primary	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	Evaluation of neurocognitive disorder using Bayley Scales of Infant Development		1 day before surgery, 7days,14 days and 21days of post-operation
Secondary	Evaluation of delirium using Pediatric Anesthesia Emergence Delirium		Within 1 days after extubation
Secondary	hemodynamics index		before skin incision, 0.5 hour after anhepatic,1 hour of neohepatic stage,the end of surgery,24 hours after operation