<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/NCT02199990</url>
  </required_header>
  <id_info>
    <org_study_id>49850254-1</org_study_id>
    <nct_id>NCT02199990</nct_id>
  </id_info>
  <brief_title>The Effect of Propofol or Etomidate on Cognitive Function for 1-3 Years Old Children</brief_title>
  <official_title>the Study of Propofol or Etomidate Affecting to the Cognitive Function for 1-3 Years Old Children in the 7 Days and 3 Months.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Guilin Medical University, China</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Guilin Medical University, China</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Based on China's guangxi guilin for a hernia operation in 1 to 3 years old preschool children&#xD;
      propofol and etomidate on behavioral and cognitive function after intravenous anesthesia in&#xD;
      according to beta protein in serum and plasma glutamate (Glutamic acid, Glu) and&#xD;
      gamma-aminobutyric acid (Gamma aminobutyric acid, GABA) level of observation, the rapid&#xD;
      development period children's cognitive function after anesthesia short-term and long-term&#xD;
      change process and its possible mechanism is studied, for the current international debate on&#xD;
      &quot;anesthetics effects on developing kids brain nerve&quot; research hot spot in the city of&#xD;
      clinical basis and research argument, for pediatric anesthesia clinical safety, provide&#xD;
      theoretical basis for the rational use of drugs.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      1. by selecting the aged 1 to 3, 100 cases of patients with elective surgery, were randomly&#xD;
           divided into the propofol group (P group), the etomidate group (group E), all the 50&#xD;
           cases, healthy age 50 cases of children (blank control group, group C) were studied;&#xD;
&#xD;
        2. the children's intelligence equation of the People's Republic of China&#xD;
           neuropsychological test: P, E group of preoperative 1 day before operation,&#xD;
           postoperative day 3, 3 months neuropsychological test, observe and evaluate patients&#xD;
           POCD is happening; Correspond to the experimental group in the same period in group C,&#xD;
           i.e., the first test (1 d) preoperatively, 4 days after the second test (3 d) after&#xD;
           operation, 3 months after the third test (3 months), observed and compared with&#xD;
           experimental neuropsychological testing of variation;&#xD;
&#xD;
        3. laboratory of brain damage index determination: extract internal jugular venous blood in&#xD;
           preoperative and perioperative finish 5 ml, with double antibody immune sandwich&#xD;
           enzyme-linked immunosorbent (ELISA) method of determination of serum S - 100 beta&#xD;
           protein levels, rapid determination of amino acid analyzer, plasma Glu, GABA levels;&#xD;
&#xD;
        4. statistical analysis: use SPSS13.0 statistical software for children with cognitive&#xD;
           function before and after operation and serum S - 100 beta protein and serum Glu, GABA&#xD;
           levels change research results should carry on the analysis of variance, P &lt; 0.05 for&#xD;
           statistical significance.&#xD;
&#xD;
        5. clear rapid development period of infants receive propofol and etomidate on plasma&#xD;
           according to beta protein after intravenous anesthesia and Glu, GABA expression and its&#xD;
           relationship between the change of cognitive function and clarify all according to&#xD;
           propofol and etomidate intravenous anesthesia on the brain is in rapid development&#xD;
           period of infant short-term and long-term postoperative cognitive function and its&#xD;
           possible mechanism, the influence of safety for children suffering from anesthesia, and&#xD;
           to provide theoretical basis for the rational use of drugs.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date>July 2014</start_date>
  <completion_date type="Anticipated">July 2015</completion_date>
  <primary_completion_date type="Anticipated">July 2015</primary_completion_date>
  <study_type>Observational [Patient Registry]</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Control</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <target_duration>3 Months</target_duration>
  <primary_outcome>
    <measure>The concentration of serum S100 β protein</measure>
    <time_frame>One hour before anesthesia, one hour after the end of anesthesia.</time_frame>
    <description>Respectively one hour before anesthesia, anesthesia for one hour 5 ml of blood from the jugular vein, serum S100β protein concentration.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Plasma levels of Glutamic acid（Glu) and Gamma-aminobutyric acid（GABA) concentration.</measure>
    <time_frame>One hour before anesthesia, one hour after the end of anesthesia.</time_frame>
    <description>Respectively one hour before anesthesia, one hour after the end of anesthesia 5 ml of blood from the jugular vein, , plasma Glu, GABA concentration.</description>
  </secondary_outcome>
  <other_outcome>
    <measure>The test results of neuropsychology</measure>
    <time_frame>One day before the operation, third days after the operation, third months after the operation</time_frame>
    <description>Use of &quot;Chinese children's intelligence equation&quot; for young children tested cognitive function evaluation.The test point in time:One day before the operation, third days after the operation, third months after the operation.</description>
  </other_outcome>
  <enrollment type="Anticipated">150</enrollment>
  <condition>Anesthesia</condition>
  <eligibility>
    <study_pop>
      <textblock>
        1.Guilin 1-3 years due to hernia surgery to receive propofol or etomidate total intravenous&#xD;
        anesthesia in children.&#xD;
&#xD;
        2.1-3 years old healthy children in 4 kindergartens of different level of teachers in the&#xD;
        Guilin city.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Signed informed consent; elective laparoscopic hernia repair and appendectomy and&#xD;
             other non cardiac operation and Department of cerebral surgery; age 1-3; ASA grade&#xD;
             I~II;&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Heart, lung, liver, kidney function was abnormal; she has a history of asthma, central&#xD;
             nervous system diseases, congenital disorders, hyperactivity, anesthesia operation&#xD;
             history; there are factors to evaluate any impact cognitive functions such as&#xD;
             language, severe visual and hearing impairment; expected before surgery in patients&#xD;
             with delayed extubation; any reason not to cooperate to complete the whole test;&#xD;
             perioperative bleeding again; postoperative anesthesia operation; operation time &gt;1h;&#xD;
             extubation in patients with delayed; quit by researchers in the process of.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>1 Year</minimum_age>
    <maximum_age>3 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Lei xun, MD</last_name>
    <role>Study Director</role>
    <affiliation>Guilin Medical University, China</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>xun lei, MD</last_name>
    <phone>(86)0773-5895812</phone>
    <email>leixun@glmc.edu.cn</email>
  </overall_contact>
  <location>
    <facility>
      <name>Guilin Medical University</name>
      <address>
        <city>Guilin</city>
        <state>Guangxi</state>
        <zip>541004</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>hong yi Jiang, MD</last_name>
      <phone>013607736057</phone>
      <email>jiangyihong6@163.com</email>
    </contact>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>July 2014</verification_date>
  <study_first_submitted>July 20, 2014</study_first_submitted>
  <study_first_submitted_qc>July 23, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 25, 2014</study_first_posted>
  <last_update_submitted>July 23, 2014</last_update_submitted>
  <last_update_submitted_qc>July 23, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">July 25, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Guilin Medical University, China</investigator_affiliation>
    <investigator_full_name>hong yi Jiang,MD</investigator_full_name>
    <investigator_title>Professor, chief physician</investigator_title>
  </responsible_party>
  <keyword>cognitive function; propofol; etomidate;</keyword>
  <!-- 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/NCT02199990
org study id: 49850254-1
nct id: NCT02199990
lead sponsor: 
has dmc: Yes
Based on China's guangxi guilin for a hernia operation in 1 to 3 years old preschool children
      propofol and etomidate on behavioral and cognitive function after intravenous anesthesia in
      according to beta protein in serum and plasma glutamate (Glutamic acid, Glu) and
      gamma-aminobutyric acid (Gamma aminobutyric acid, GABA) level of observation, the rapid
      development period children's cognitive function after anesthesia short-term and long-term
      change process and its possible mechanism is studied, for the current international debate on
      "anesthetics effects on developing kids brain nerve" research hot spot in the city of
      clinical basis and research argument, for pediatric anesthesia clinical safety, provide
      theoretical basis for the rational use of drugs.
1. by selecting the aged 1 to 3, 100 cases of patients with elective surgery, were randomly
           divided into the propofol group (P group), the etomidate group (group E), all the 50
           cases, healthy age 50 cases of children (blank control group, group C) were studied;

        2. the children's intelligence equation of the People's Republic of China
           neuropsychological test: P, E group of preoperative 1 day before operation,
           postoperative day 3, 3 months neuropsychological test, observe and evaluate patients
           POCD is happening; Correspond to the experimental group in the same period in group C,
           i.e., the first test (1 d) preoperatively, 4 days after the second test (3 d) after
           operation, 3 months after the third test (3 months), observed and compared with
           experimental neuropsychological testing of variation;

        3. laboratory of brain damage index determination: extract internal jugular venous blood in
           preoperative and perioperative finish 5 ml, with double antibody immune sandwich
           enzyme-linked immunosorbent (ELISA) method of determination of serum S - 100 beta
           protein levels, rapid determination of amino acid analyzer, plasma Glu, GABA levels;

        4. statistical analysis: use SPSS13.0 statistical software for children with cognitive
           function before and after operation and serum S - 100 beta protein and serum Glu, GABA
           levels change research results should carry on the analysis of variance, P < 0.05 for
           statistical significance.

        5. clear rapid development period of infants receive propofol and etomidate on plasma
           according to beta protein after intravenous anesthesia and Glu, GABA expression and its
           relationship between the change of cognitive function and clarify all according to
           propofol and etomidate intravenous anesthesia on the brain is in rapid development
           period of infant short-term and long-term postoperative cognitive function and its
           possible mechanism, the influence of safety for children suffering from anesthesia, and
           to provide theoretical basis for the rational use of drugs.
observational model: Case-Control
time perspective: Prospective
measure: The concentration of serum S100 β protein
time frame: One hour before anesthesia, one hour after the end of anesthesia.
description: Respectively one hour before anesthesia, anesthesia for one hour 5 ml of blood from the jugular vein, serum S100β protein concentration.
measure: Plasma levels of Glutamic acid（Glu) and Gamma-aminobutyric acid（GABA) concentration.
time frame: One hour before anesthesia, one hour after the end of anesthesia.
description: Respectively one hour before anesthesia, one hour after the end of anesthesia 5 ml of blood from the jugular vein, , plasma Glu, GABA concentration.
measure: The test results of neuropsychology
time frame: One day before the operation, third days after the operation, third months after the operation
description: Use of "Chinese children's intelligence equation" for young children tested cognitive function evaluation.The test point in time:One day before the operation, third days after the operation, third months after the operation.
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 1 Year
maximum age: 3 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Lei xun, MD
role: Study Director
affiliation: Guilin Medical University, China
last name: xun lei, MD
phone: (86)0773-5895812
email: leixun@glmc.edu.cn
facility: 
status: Recruiting
contact: 
country: China
responsible party type: Principal Investigator
investigator affiliation: Guilin Medical University, China
investigator full name: hong yi Jiang,MD
investigator title: Professor, chief physician