<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03024840</url>
  </required_header>
  <id_info>
    <org_study_id>2016N0039KY</org_study_id>
    <nct_id>NCT03024840</nct_id>
  </id_info>
  <brief_title>Anaesthetic and Pediatric Living Related Liver Transplantation</brief_title>
  <official_title>The Effect of Sevoflurane or Propofol on Brain Injury and Neurocognitive in Pediatric Living Related Liver Transplantation</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Tianjin First Central Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Tianjin First Central Hospital</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      To study the effect of different anaesthetic methods on pediatric neurocognitive development&#xD;
      and cerebral injury during pediatric living related liver transplantation .&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Since the 1960 s, with the successful development of liver transplantation, it has become an&#xD;
      important method for the treatment of patients with end-stage liver disease.Biliary atresia1&#xD;
      is the most frequent causes of pediatric end-stage liver disease,.The morbidity of congenital&#xD;
      biliary atresia is 1/8000-18, 0002 ,which influence the patients' overall growth and&#xD;
      development situation. The rising of living donor liver transplantation has provide children&#xD;
      with the chance of a timely treatment since the 1980 s, It is no doubt that pediatric liver&#xD;
      transplantation is facing with many complications, including the most importance of&#xD;
      neurocognitive development .Now the researches of neurological complications is less&#xD;
      .According to statistics, the incidence of neurological complications after pediatric liver&#xD;
      transplantation was 8% - 46% . So it is necessary to research the neurological complications&#xD;
      and brain protection strategy .Previous studies have studied that some anaesthetic have&#xD;
      uncertain affect on the development of children.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Enrolling by invitation</last_known_status>
  <start_date>December 2016</start_date>
  <completion_date type="Anticipated">December 2017</completion_date>
  <primary_completion_date type="Anticipated">May 2017</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Prevention</primary_purpose>
    <masking>Single (Participant)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Evidence of cerebral injury including S-100 β protein, neurospecific enolase confirmed by electrochemiluminescence</measure>
    <time_frame>before skin incision, 0.5 hour after anhepatic,1 hour of neohepatic stage,the end of surgery,24 hours after operation</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Evidences of inflammatory factor such as interleukin-6，interleukin-10，et al confirmed by electrochemiluminescence</measure>
    <time_frame>before skin incision, 0.5 hour after anhepatic,1 hour of neohepatic stage,the end of surgery,24 hours after operation</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Evaluation of neurocognitive disorder using Bayley Scales of Infant Development</measure>
    <time_frame>1 day before surgery, 7days,14 days and 21days of post-operation</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Evaluation of delirium using Pediatric Anesthesia Emergence Delirium</measure>
    <time_frame>Within 1 days after extubation</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>hemodynamics index</measure>
    <time_frame>before skin incision, 0.5 hour after anhepatic,1 hour of neohepatic stage,the end of surgery,24 hours after operation</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">60</enrollment>
  <condition>Liver Transplantation</condition>
  <condition>Children</condition>
  <arm_group>
    <arm_group_label>sevoflurane</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Sevoflurane is inhalated with 1%-2% after anesthesia induction until end of the surgery.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>propofol</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Propofol is injected with 9-15 mg/kg/h after anesthesia induction until end of the surgery.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Sevoflurane</intervention_name>
    <description>Sevoflurane: 1%~2%</description>
    <arm_group_label>sevoflurane</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Propofol</intervention_name>
    <description>Propofol: 9-15 mg/kg/h</description>
    <arm_group_label>propofol</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Children with end-stage liver disease Children with biliary atresia&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  pre-existing cerebral disease second liver transplantation&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>4 Months</minimum_age>
    <maximum_age>12 Months</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>No.24 Fukang Road,Nankai District</name>
      <address>
        <city>Tianjin</city>
        <state>Tianjin</state>
        <zip>300192</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>January 2017</verification_date>
  <study_first_submitted>December 23, 2016</study_first_submitted>
  <study_first_submitted_qc>January 15, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 19, 2017</study_first_posted>
  <last_update_submitted>January 15, 2017</last_update_submitted>
  <last_update_submitted_qc>January 15, 2017</last_update_submitted_qc>
  <last_update_posted type="Estimate">January 19, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Tianjin First Central Hospital</investigator_affiliation>
    <investigator_full_name>Wenli Yu</investigator_full_name>
    <investigator_title>Wenli Yu,PhD ,Department of Anesthesiology,Tianjin First Center Hospital</investigator_title>
  </responsible_party>
  <keyword>Propofol</keyword>
  <keyword>Neurocognitive Disorders</keyword>
  <keyword>Liver transplantation</keyword>
  <keyword>Pediatrics</keyword>
  <keyword>Brain Injuries</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Brain Injuries</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Propofol</mesh_term>
    <mesh_term>Sevoflurane</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03024840
org study id: 2016N0039KY
nct id: NCT03024840
lead sponsor: 
has dmc: Yes
To study the effect of different anaesthetic methods on pediatric neurocognitive development
      and cerebral injury during pediatric living related liver transplantation .
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.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: Single (Participant)
measure: 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
measure: 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
measure: Evaluation of neurocognitive disorder using Bayley Scales of Infant Development
time frame: 1 day before surgery, 7days,14 days and 21days of post-operation
measure: Evaluation of delirium using Pediatric Anesthesia Emergence Delirium
time frame: Within 1 days after extubation
measure: 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
arm group label: sevoflurane
arm group type: Experimental
description: Sevoflurane is inhalated with 1%-2% after anesthesia induction until end of the surgery.
arm group label: propofol
arm group type: Experimental
description: Propofol is injected with 9-15 mg/kg/h after anesthesia induction until end of the surgery.
intervention type: Drug
intervention name: Sevoflurane
description: Sevoflurane: 1%~2%
arm group label: sevoflurane
intervention type: Drug
intervention name: Propofol
description: Propofol: 9-15 mg/kg/h
arm group label: propofol
criteria: 
gender: All
minimum age: 4 Months
maximum age: 12 Months
healthy volunteers: No
facility: 
country: China
responsible party type: Principal Investigator
investigator affiliation: Tianjin First Central Hospital
investigator full name: Wenli Yu
investigator title: Wenli Yu,PhD ,Department of Anesthesiology,Tianjin First Center Hospital
mesh term: Brain Injuries
mesh term: Propofol
mesh term: Sevoflurane
sharing ipd: No