Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Anaesthetic and Pediatric Living Related Liver Transplantation

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03024840
Recruitment Status : Unknown
Verified January 2017 by Wenli Yu, Tianjin First Central Hospital.
Recruitment status was:  Enrolling by invitation
First Posted : January 19, 2017
Last Update Posted : January 19, 2017
Sponsor:
Information provided by (Responsible Party):
Wenli Yu, 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 .

Condition or disease Intervention/treatment Phase
Liver Transplantation Children Drug: Sevoflurane Drug: Propofol Not Applicable

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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Prevention
Official Title: The Effect of Sevoflurane or Propofol on Brain Injury and Neurocognitive in Pediatric Living Related Liver Transplantation
Study Start Date : December 2016
Estimated Primary Completion Date : May 2017
Estimated Study Completion Date : December 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: sevoflurane
Sevoflurane is inhalated with 1%-2% after anesthesia induction until end of the surgery.
Drug: Sevoflurane
Sevoflurane: 1%~2%

Experimental: propofol
Propofol is injected with 9-15 mg/kg/h after anesthesia induction until end of the surgery.
Drug: Propofol
Propofol: 9-15 mg/kg/h




Primary Outcome Measures :
  1. 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 ]
  2. 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 ]

Secondary Outcome Measures :
  1. Evaluation of neurocognitive disorder using Bayley Scales of Infant Development [ Time Frame: 1 day before surgery, 7days,14 days and 21days of post-operation ]
  2. Evaluation of delirium using Pediatric Anesthesia Emergence Delirium [ Time Frame: Within 1 days after extubation ]
  3. hemodynamics index [ Time Frame: before skin incision, 0.5 hour after anhepatic,1 hour of neohepatic stage,the end of surgery,24 hours after operation ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   4 Months to 12 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • pre-existing cerebral disease second liver transplantation

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03024840


Locations
Layout table for location information
China, Tianjin
No.24 Fukang Road,Nankai District
Tianjin, Tianjin, China, 300192
Sponsors and Collaborators
Tianjin First Central Hospital

Layout table for additonal information
Responsible Party: Wenli Yu, Wenli Yu,PhD ,Department of Anesthesiology,Tianjin First Center Hospital, Tianjin First Central Hospital
ClinicalTrials.gov Identifier: NCT03024840     History of Changes
Other Study ID Numbers: 2016N0039KY
First Posted: January 19, 2017    Key Record Dates
Last Update Posted: January 19, 2017
Last Verified: January 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Wenli Yu, Tianjin First Central Hospital:
Propofol
Neurocognitive Disorders
Liver transplantation
Pediatrics
Brain Injuries
Additional relevant MeSH terms:
Layout table for MeSH terms
Brain Injuries
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Craniocerebral Trauma
Trauma, Nervous System
Wounds and Injuries
Propofol
Sevoflurane
Hypnotics and Sedatives
Central Nervous System Depressants
Physiological Effects of Drugs
Anesthetics, Intravenous
Anesthetics, General
Anesthetics
Platelet Aggregation Inhibitors
Anesthetics, Inhalation