<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/NCT02977455</url>
  </required_header>
  <id_info>
    <org_study_id>304460568</org_study_id>
    <nct_id>NCT02977455</nct_id>
  </id_info>
  <brief_title>Study on the Neurovascular Coupling Function in Patients Undergoing Cardiac Surgery</brief_title>
  <sponsors>
    <lead_sponsor>
      <agency>Xiangya Hospital of Central South University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Xiangya Hospital of Central South University</source>
  <brief_summary>
    <textblock>
      Existing researches show that brain is an organ highly dependent on continuous blood supply.&#xD;
      Energy and oxygen required for normal physiological activities in the brain are stably&#xD;
      maintained by a neurovascular regulatory mechanism, also known as functional congestion.&#xD;
      While under pathological condition such as ischemia, this regulatory mechanism would be&#xD;
      impaired and brain function loss and tissue damage occur. During anesthesia in cardiac&#xD;
      surgery, inevitable circulatory fluctuations could result in decreasing blood pressure and&#xD;
      cerebral blood flow and therefore brain tissue is in ischemia. In this situation the&#xD;
      neurovascular regulatory mechanism will function and the brain oxygen saturation also changes&#xD;
      based on how this mechanism is influenced. the investigators were devoted to observe how this&#xD;
      mechanism was influenced during surgery and how the neural function recovers after surgery so&#xD;
      to explore the relationship between them.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Preoperative: Routine examinations, including pulse, blood pressure, electrocardiogram,&#xD;
      hematological and biochemical tests from blood and urine. Anesthetist paid visit to patient&#xD;
      and made judgement whether patient could be included or not based on rating of cognition.&#xD;
      Anesthetist also introduced the research plan in detail and patient or guardian signed&#xD;
      consent out of participants' own free will.&#xD;
&#xD;
      Intraoperative:&#xD;
&#xD;
        1. After admission, the investigators recorded regular vital signs and measured basic&#xD;
           cerebral oxygen saturation, then inducted anesthesia.&#xD;
&#xD;
        2. After induction the investigators recorded anesthetic dose, vital signs and measured&#xD;
           cerebral blood flow and oxygen saturation changes.&#xD;
&#xD;
        3. Using BIS to monitor we controlled the anesthesia depth at BIS value of 40 to 60.&#xD;
&#xD;
        4. Assuring patient's vital signs to be stable and safe, the investigators gave propofol (3&#xD;
           mg/kg, from Fresenius Kabi) intravenously when BIS was greater than 60 and observed&#xD;
           while recorded any changes in BIS value, cerebral blood flow and oxygen saturation.&#xD;
&#xD;
      Postoperative: Patient was transferred to chest surgery ICU and vital signs were recorded.&#xD;
&#xD;
      Clinical data record:&#xD;
&#xD;
      General information: including name, gender, age, height, weight, education, name of disease,&#xD;
      surgery method, admission number, ID number, address, contact information and so on;&#xD;
&#xD;
      Preoperative: cardiovascular medicine, vasoactive drugs, lab test results, result reviews,&#xD;
      cognition rating and cerebral blood oxygen saturation basic value;&#xD;
&#xD;
      Intraoperative: circulatory parameters, medicine, temperature, BIS value, cerebral blood&#xD;
      oxygen saturation and blood flow parameters;&#xD;
&#xD;
      Postoperative: extubation time, time of vasoactive drug administration, cognition rating&#xD;
      (postoperative day 3 and day 7), postoperative complications (sudden cardiac death,&#xD;
      disturbance of consciousness, pulmonary infection, acute lung injury, acute pulmonary&#xD;
      embolism, cerebral infarction and so on);&#xD;
&#xD;
      Postoperative stay in hospital, ICU stay time, hospitalization cost, readmission, mortality&#xD;
      (one, three and six months) and so on.&#xD;
&#xD;
      Cognition rating chart: based on &quot;Direction of Chinese Binet Tests (third edition)&quot;.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Enrolling by invitation</last_known_status>
  <start_date>October 2016</start_date>
  <primary_completion_date type="Anticipated">March 2017</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Control</observational_model>
    <time_perspective>Cross-Sectional</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Thirty of participants with Cognitive function assessment based on &quot;Direction of Chinese Binet Tests (third edition)&quot;</measure>
    <time_frame>6 months</time_frame>
    <description>IQ scores will be used to quantify cognitive function</description>
  </primary_outcome>
  <enrollment type="Anticipated">30</enrollment>
  <condition>Neurovascular Coupling Mechanism and Cognitive Function</condition>
  <eligibility>
    <study_pop>
      <textblock>
        Cardiac surgery patients&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Age &lt;12 years old&#xD;
&#xD;
          2. Will take cardiac surgery and general anesthesia&#xD;
&#xD;
          3. Cognitive status is normal&#xD;
&#xD;
          4. Cardiac function grade Ⅱ-Ⅲ (using the NYHA cardiac function classification)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Emergency surgery&#xD;
&#xD;
          2. ASA-V or VI&#xD;
&#xD;
          3. Coagulation disorders,multiple organs dysfunction, endocrine system diseases and&#xD;
             severe infectious diseases&#xD;
&#xD;
          4. Patients have been installed pacemakers&#xD;
&#xD;
          5. Suspected or indeed alcohol, drug abuse history&#xD;
&#xD;
          6. Can not cooperate with research, such as the following: language understanding, mental&#xD;
             illness, etc.&#xD;
&#xD;
          7. Participated in other clinical trials&#xD;
&#xD;
          8. Perioperative stroke&#xD;
&#xD;
          9. The researchers believe that should not be included in the study&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>2 Years</minimum_age>
    <maximum_age>12 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <verification_date>October 2016</verification_date>
  <study_first_submitted>November 16, 2016</study_first_submitted>
  <study_first_submitted_qc>November 27, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 30, 2016</study_first_posted>
  <last_update_submitted>November 27, 2016</last_update_submitted>
  <last_update_submitted_qc>November 27, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">November 30, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <!-- 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/NCT02977455
org study id: 304460568
nct id: NCT02977455
lead sponsor: 
Existing researches show that brain is an organ highly dependent on continuous blood supply.
      Energy and oxygen required for normal physiological activities in the brain are stably
      maintained by a neurovascular regulatory mechanism, also known as functional congestion.
      While under pathological condition such as ischemia, this regulatory mechanism would be
      impaired and brain function loss and tissue damage occur. During anesthesia in cardiac
      surgery, inevitable circulatory fluctuations could result in decreasing blood pressure and
      cerebral blood flow and therefore brain tissue is in ischemia. In this situation the
      neurovascular regulatory mechanism will function and the brain oxygen saturation also changes
      based on how this mechanism is influenced. the investigators were devoted to observe how this
      mechanism was influenced during surgery and how the neural function recovers after surgery so
      to explore the relationship between them.
Preoperative: Routine examinations, including pulse, blood pressure, electrocardiogram,
      hematological and biochemical tests from blood and urine. Anesthetist paid visit to patient
      and made judgement whether patient could be included or not based on rating of cognition.
      Anesthetist also introduced the research plan in detail and patient or guardian signed
      consent out of participants' own free will.

      Intraoperative:

        1. After admission, the investigators recorded regular vital signs and measured basic
           cerebral oxygen saturation, then inducted anesthesia.

        2. After induction the investigators recorded anesthetic dose, vital signs and measured
           cerebral blood flow and oxygen saturation changes.

        3. Using BIS to monitor we controlled the anesthesia depth at BIS value of 40 to 60.

        4. Assuring patient's vital signs to be stable and safe, the investigators gave propofol (3
           mg/kg, from Fresenius Kabi) intravenously when BIS was greater than 60 and observed
           while recorded any changes in BIS value, cerebral blood flow and oxygen saturation.

      Postoperative: Patient was transferred to chest surgery ICU and vital signs were recorded.

      Clinical data record:

      General information: including name, gender, age, height, weight, education, name of disease,
      surgery method, admission number, ID number, address, contact information and so on;

      Preoperative: cardiovascular medicine, vasoactive drugs, lab test results, result reviews,
      cognition rating and cerebral blood oxygen saturation basic value;

      Intraoperative: circulatory parameters, medicine, temperature, BIS value, cerebral blood
      oxygen saturation and blood flow parameters;

      Postoperative: extubation time, time of vasoactive drug administration, cognition rating
      (postoperative day 3 and day 7), postoperative complications (sudden cardiac death,
      disturbance of consciousness, pulmonary infection, acute lung injury, acute pulmonary
      embolism, cerebral infarction and so on);

      Postoperative stay in hospital, ICU stay time, hospitalization cost, readmission, mortality
      (one, three and six months) and so on.

      Cognition rating chart: based on "Direction of Chinese Binet Tests (third edition)".
observational model: Case-Control
time perspective: Cross-Sectional
measure: Thirty of participants with Cognitive function assessment based on "Direction of Chinese Binet Tests (third edition)"
time frame: 6 months
description: IQ scores will be used to quantify cognitive function
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 2 Years
maximum age: 12 Years
healthy volunteers: No
responsible party type: Sponsor