xml: <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/NCT06012955</url>
    </required_header>
    <id_info>
      <org_study_id>TCI202112</org_study_id>
      <nct_id>NCT06012955</nct_id>
    </id_info>
    <brief_title>Study on the Effect of Target-controlled Infusion for General Anesthesia in Cardiac Surgery</brief_title>
    <official_title>Study on the Effect of Target-controlled Infusion of Propofol and Remifentanil for Patients Undergoing Cardiac Surgery</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Wuhan Union Hospital, China</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Wuhan Union Hospital, China</source>
    <oversight_info>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        The purpose of the study was to evaluate whether individualized general anesthesia with&#xD;
        target-controlled infusion could help patients wake up early for extubation and reduce the&#xD;
        incidence of postoperative complications, and to investigate the effectiveness and safety of&#xD;
        its application in patients undergoing cardiac surgery.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Recruiting</overall_status>
    <start_date type="Anticipated">August 30, 2023</start_date>
    <completion_date type="Anticipated">June 30, 2024</completion_date>
    <primary_completion_date type="Anticipated">December 31, 2023</primary_completion_date>
    <study_type>Observational</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <observational_model>Cohort</observational_model>
      <time_perspective>Retrospective</time_perspective>
    </study_design_info>
    <primary_outcome>
      <measure>Duration of postoperative mechanical ventilation</measure>
      <time_frame>4 weeks after surgery</time_frame>
      <description>Duration of mechanical ventilation was defined as the time from the end of surgery to tracheal extubation</description>
    </primary_outcome>
    <number_of_groups>2</number_of_groups>
    <enrollment type="Anticipated">2000</enrollment>
    <condition>Postoperative Mechanical Ventilation Time</condition>
    <arm_group>
      <arm_group_label>TCI group</arm_group_label>
      <description>patients receiving general anesthesia using target-controlled infusion delivery system</description>
    </arm_group>
    <arm_group>
      <arm_group_label>MCI group</arm_group_label>
      <description>patients receiving general anesthesia using conventional manual controlled infusion delivery</description>
    </arm_group>
    <intervention>
      <intervention_type>Device</intervention_type>
      <intervention_name>Target-controlled infusion (TCI) systems</intervention_name>
      <description>Target-controlled infusion (TCI) with propofol and remifentanil was used for anesthesia induction and maintenance</description>
      <arm_group_label>TCI group</arm_group_label>
    </intervention>
    <eligibility>
      <study_pop>
        <textblock>
          Patients aged 18 years or olderundergoing cardiac surgery under general anesthesia&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  All patients aged 18 years and older who underwent cardiac surgery&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Mechanical ventilation support before surgery;&#xD;
  &#xD;
            -  Combined with any type of non-cardiac surgeries;&#xD;
  &#xD;
            -  Second exploratory thoracotomy after surgery;&#xD;
  &#xD;
            -  Died or discharged within 48 h after surgery;&#xD;
  &#xD;
            -  Missing clinical data&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_contact>
      <last_name>Qingping Wu</last_name>
      <phone>13971605283</phone>
      <email>wqp1968@163.com</email>
    </overall_contact>
    <location>
      <facility>
        <name>Wuhan Union Hospital</name>
        <address>
          <city>Wuhan</city>
          <state>Hubei</state>
          <zip>430022</zip>
          <country>China</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Qingping Wu</last_name>
        <phone>13971605283</phone>
        <email>wqp1968@163.com</email>
      </contact>
    </location>
    <location_countries>
      <country>China</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 20, 2023</study_first_submitted>
    <study_first_submitted_qc>August 25, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 28, 2023</study_first_posted>
    <last_update_submitted>August 25, 2023</last_update_submitted>
    <last_update_submitted_qc>August 25, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 28, 2023</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>
  
  
text: 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/NCT06012955
  org study id: TCI202112
  nct id: NCT06012955
  lead sponsor: 
  is fda regulated drug: No
  is fda regulated device: No
  The purpose of the study was to evaluate whether individualized general anesthesia with
        target-controlled infusion could help patients wake up early for extubation and reduce the
        incidence of postoperative complications, and to investigate the effectiveness and safety of
        its application in patients undergoing cardiac surgery.
  observational model: Cohort
  time perspective: Retrospective
  measure: Duration of postoperative mechanical ventilation
  time frame: 4 weeks after surgery
  description: Duration of mechanical ventilation was defined as the time from the end of surgery to tracheal extubation
  arm group label: TCI group
  description: patients receiving general anesthesia using target-controlled infusion delivery system
  arm group label: MCI group
  description: patients receiving general anesthesia using conventional manual controlled infusion delivery
  intervention type: Device
  intervention name: Target-controlled infusion (TCI) systems
  description: Target-controlled infusion (TCI) with propofol and remifentanil was used for anesthesia induction and maintenance
  arm group label: TCI group
  study pop: 
  sampling method: Probability Sample
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: No
  last name: Qingping Wu
  phone: 13971605283
  email: wqp1968@163.com
  facility: 
  status: Recruiting
  contact: 
  country: China
  responsible party type: Sponsor