<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/NCT02213718</url>
  </required_header>
  <id_info>
    <org_study_id>20140607</org_study_id>
    <secondary_id>20140627</secondary_id>
    <nct_id>NCT02213718</nct_id>
  </id_info>
  <brief_title>The Effect of Desflurane on Myocardial Function in Patients Undergoing Coronary Artery Bypass Grafting</brief_title>
  <official_title>The Effect of Desflurane on Myocardial Function in Patients Undergoing Coronary Artery Bypass Grafting</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Huazhong University of Science and Technology</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Huazhong University of Science and Technology</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study is to assess the effect of desflurane on myocardial function in patents who&#xD;
      underwent coronary artery bypass grafting.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Desﬂurane, one of the third-generation inhaled anesthetics, is introduced in clinical&#xD;
      practice in 1990s. Decades of clinical use has provided evidence for desﬂurane's safe and&#xD;
      efﬁcacious use as a general anesthetic. Compared with other volatile anesthestics, it has&#xD;
      several characteristics: lower blood and lipid solubility, more stable in vitro and the&#xD;
      lowest in vivo metabolism. Its particular low fat solubility properties promote rapid&#xD;
      equilibration and rapid elimination at the end of anesthesia which reduces slow compartment&#xD;
      accumulation and promotes predictable emergence, early extubation, and the ability to rapidly&#xD;
      transfer patients from the operating room to the recovery unit. In addition, several&#xD;
      investigations found that patients with desflurane anesthesia recovered their protective&#xD;
      airway reﬂexes and awakened to a degree sufﬁcient to minimize the stay in the high dependency&#xD;
      recovery area.&#xD;
&#xD;
      A burgeoning body of investigations has shown that desflurane can directly act on myocardial&#xD;
      and vascular functions. Desflurane has coronary vasodilative effects in in situ canine hearts&#xD;
      which is comparable to sevoflurane does. Although it is controversial regarding to the effect&#xD;
      of desflurane on myocardial excitation-contraction coupling and electrophysiologic behavior,&#xD;
      a elaborated study found desflurane induced a positive inotropic effect in rat myocardium in&#xD;
      vitro compared with isoflurane. A recent study suggested that desflurane decreased right&#xD;
      ventricular contractility much less and maintained the right over left pressures ratio at&#xD;
      more favorable values compared with sevoflurane. Furthermore, substantial investigations&#xD;
      found that clinically relevant concentration desflurane preconditioning or postconditioning&#xD;
      could protect myocardium from ischemia-reperfusion in mammalian animal models or isolated&#xD;
      human cardiac tissues. However, it is unclear whether desflurane can provide protection for&#xD;
      patients with coronary artery disease. Therefore, this study is designed to investigate the&#xD;
      effect of desflurane on myocardial function in patents who underwent coronary artery bypass&#xD;
      grafting.&#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">June 2017</completion_date>
  <primary_completion_date type="Anticipated">January 2017</primary_completion_date>
  <phase>Phase 4</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>Double (Participant, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Serum Concentration of cTnI</measure>
    <time_frame>48 hours</time_frame>
    <description>at the begingineg of the surgery,immediately after surgery,4 hours after the surgery, 8 hours after the surgery, 12 hours after the surgery, 24 hours after the surgery</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Continuous Monitoring of ECG</measure>
    <time_frame>participants will be followed for the duration of hospital stay, an expected average of 5 weeks</time_frame>
    <description>participants will be followed for the duration of hospital stay, an expected average of 5 weeks.ECG incidents such as tachycardia, bradycardia, premature ventricualr contraction and ST segment changes will be monitored and recorded.</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Incidence of segmental wall motion</measure>
    <time_frame>Incidence of segmental wall motions will be monitored during the surgery, an expected average of 4 hours.</time_frame>
    <description>Incidence of segmental wall motions will be monitored during the surgery, an expected average of 4 hours.</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">60</enrollment>
  <condition>Coronary Artery Bypass Graft Redo</condition>
  <condition>General Anesthetic Drug Adverse Reaction</condition>
  <arm_group>
    <arm_group_label>Desflurane</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>desflurane (7%-8% end-tidal concentration), sufentanil (TCI: 2-3 ng/ml) and vecuronium (0.04mg/kg/h)</description>
  </arm_group>
  <arm_group>
    <arm_group_label>propofol</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>intravenous administration of sufentanil (1μg/kg), etomidate(0.3mg/kg) and vecuronium (0.08mg/kg). The anesthesia is maintained with propofol (TCI:3.5-4.0μg/min), sufentanil (TCI: 2-3 ng/ml) and vecuronium (0.04mg/kg/h).</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Desflurane</intervention_name>
    <description>desflurane (7%-8% end-tidal concentration)</description>
    <arm_group_label>Desflurane</arm_group_label>
    <other_name>brand names：Baxter</other_name>
    <other_name>serial numbers and code names：not available yet</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>propofol</intervention_name>
    <description>propofol (TCI:3.5-4.0μg/min)</description>
    <arm_group_label>propofol</arm_group_label>
    <other_name>brand name：Diprivan</other_name>
    <other_name>serial numbers and code names：not available yet</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>sufentanil</intervention_name>
    <description>TCI: 2-3 ng/ml during the duration of surgery, an expected average of 4 hours</description>
    <arm_group_label>Desflurane</arm_group_label>
    <arm_group_label>propofol</arm_group_label>
    <other_name>brand name: Yichang Humanwell pharmaceutical co.,LTD</other_name>
    <other_name>serial numbers and code names: not available yet</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        1. Diagnosed with CAD 2. ASAⅡ～Ⅲ&#xD;
&#xD;
        -&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Left ventricular ejection fraction &lt;40%&#xD;
&#xD;
          2. Left ventricular aneurysm&#xD;
&#xD;
          3. Acute myocardial infarction in latest two weeks, atrial fibrillation&#xD;
&#xD;
          4. Associated vascular diseases, severe systemic diseases involving the renal and hepatic&#xD;
             systems&#xD;
&#xD;
          5. Respiratory disease( forced vital capacity less than 50% of predicted values )&#xD;
&#xD;
          6. Preoperative left bundle branch block -&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>40 Years</minimum_age>
    <maximum_age>60 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Ailin Luo, Doctor</last_name>
    <role>Principal Investigator</role>
    <affiliation>Tongji Hospital</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Ailin Luo, Doctor</last_name>
    <phone>86-13507122565</phone>
    <email>alluo@tjmu.tjh.edu.cn</email>
  </overall_contact>
  <location>
    <facility>
      <name>Dept. of Anesthesiolgy, Tongji hospital of Tongji Medical College, Huazhong University of Science and Technology</name>
      <address>
        <city>Wuhan</city>
        <state>Hubei</state>
        <zip>430030</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Ailin Luo, Doctor</last_name>
      <phone>86-13507122565</phone>
      <email>alluo@tjmu.tjh.edu.cn</email>
    </contact>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <link>
    <url>http://www.hust.edu.cn/</url>
    <description>educational</description>
  </link>
  <link>
    <url>http://www.tjmu.edu.cn/</url>
    <description>educational</description>
  </link>
  <link>
    <url>http://www.tjh.com.cn/</url>
    <description>research</description>
  </link>
  <verification_date>August 2014</verification_date>
  <study_first_submitted>July 31, 2014</study_first_submitted>
  <study_first_submitted_qc>August 7, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 11, 2014</study_first_posted>
  <last_update_submitted>August 7, 2014</last_update_submitted>
  <last_update_submitted_qc>August 7, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">August 11, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Huazhong University of Science and Technology</investigator_affiliation>
    <investigator_full_name>Xin Chen</investigator_full_name>
    <investigator_title>staff</investigator_title>
  </responsible_party>
  <keyword>Desflurane</keyword>
  <keyword>myocardial function</keyword>
  <keyword>Coronary Artery Bypass Surgery</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Drug-Related Side Effects and Adverse Reactions</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Sufentanil</mesh_term>
    <mesh_term>Propofol</mesh_term>
    <mesh_term>Desflurane</mesh_term>
  </intervention_browse>
  <!-- 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/NCT02213718
org study id: 20140607
secondary id: 20140627
nct id: NCT02213718
lead sponsor: 
has dmc: Yes
This study is to assess the effect of desflurane on myocardial function in patents who
      underwent coronary artery bypass grafting.
Desﬂurane, one of the third-generation inhaled anesthetics, is introduced in clinical
      practice in 1990s. Decades of clinical use has provided evidence for desﬂurane's safe and
      efﬁcacious use as a general anesthetic. Compared with other volatile anesthestics, it has
      several characteristics: lower blood and lipid solubility, more stable in vitro and the
      lowest in vivo metabolism. Its particular low fat solubility properties promote rapid
      equilibration and rapid elimination at the end of anesthesia which reduces slow compartment
      accumulation and promotes predictable emergence, early extubation, and the ability to rapidly
      transfer patients from the operating room to the recovery unit. In addition, several
      investigations found that patients with desflurane anesthesia recovered their protective
      airway reﬂexes and awakened to a degree sufﬁcient to minimize the stay in the high dependency
      recovery area.

      A burgeoning body of investigations has shown that desflurane can directly act on myocardial
      and vascular functions. Desflurane has coronary vasodilative effects in in situ canine hearts
      which is comparable to sevoflurane does. Although it is controversial regarding to the effect
      of desflurane on myocardial excitation-contraction coupling and electrophysiologic behavior,
      a elaborated study found desflurane induced a positive inotropic effect in rat myocardium in
      vitro compared with isoflurane. A recent study suggested that desflurane decreased right
      ventricular contractility much less and maintained the right over left pressures ratio at
      more favorable values compared with sevoflurane. Furthermore, substantial investigations
      found that clinically relevant concentration desflurane preconditioning or postconditioning
      could protect myocardium from ischemia-reperfusion in mammalian animal models or isolated
      human cardiac tissues. However, it is unclear whether desflurane can provide protection for
      patients with coronary artery disease. Therefore, this study is designed to investigate the
      effect of desflurane on myocardial function in patents who underwent coronary artery bypass
      grafting.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: Double (Participant, Investigator)
measure: Serum Concentration of cTnI
time frame: 48 hours
description: at the begingineg of the surgery,immediately after surgery,4 hours after the surgery, 8 hours after the surgery, 12 hours after the surgery, 24 hours after the surgery
measure: Continuous Monitoring of ECG
time frame: participants will be followed for the duration of hospital stay, an expected average of 5 weeks
description: participants will be followed for the duration of hospital stay, an expected average of 5 weeks.ECG incidents such as tachycardia, bradycardia, premature ventricualr contraction and ST segment changes will be monitored and recorded.
measure: Incidence of segmental wall motion
time frame: Incidence of segmental wall motions will be monitored during the surgery, an expected average of 4 hours.
description: Incidence of segmental wall motions will be monitored during the surgery, an expected average of 4 hours.
arm group label: Desflurane
arm group type: Experimental
description: desflurane (7%-8% end-tidal concentration), sufentanil (TCI: 2-3 ng/ml) and vecuronium (0.04mg/kg/h)
arm group label: propofol
arm group type: Active Comparator
description: intravenous administration of sufentanil (1μg/kg), etomidate(0.3mg/kg) and vecuronium (0.08mg/kg). The anesthesia is maintained with propofol (TCI:3.5-4.0μg/min), sufentanil (TCI: 2-3 ng/ml) and vecuronium (0.04mg/kg/h).
intervention type: Drug
intervention name: Desflurane
description: desflurane (7%-8% end-tidal concentration)
arm group label: Desflurane
other name: brand names：Baxter
other name: serial numbers and code names：not available yet
intervention type: Drug
intervention name: propofol
description: propofol (TCI:3.5-4.0μg/min)
arm group label: propofol
other name: brand name：Diprivan
other name: serial numbers and code names：not available yet
intervention type: Drug
intervention name: sufentanil
description: TCI: 2-3 ng/ml during the duration of surgery, an expected average of 4 hours
arm group label: Desflurane
arm group label: propofol
other name: brand name: Yichang Humanwell pharmaceutical co.,LTD
other name: serial numbers and code names: not available yet
criteria: 
gender: All
minimum age: 40 Years
maximum age: 60 Years
healthy volunteers: No
last name: Ailin Luo, Doctor
role: Principal Investigator
affiliation: Tongji Hospital
last name: Ailin Luo, Doctor
phone: 86-13507122565
email: alluo@tjmu.tjh.edu.cn
facility: 
status: Recruiting
contact: 
country: China
url: http://www.hust.edu.cn/
description: educational
url: http://www.tjmu.edu.cn/
description: educational
url: http://www.tjh.com.cn/
description: research
responsible party type: Principal Investigator
investigator affiliation: Huazhong University of Science and Technology
investigator full name: Xin Chen
investigator title: staff
mesh term: Drug-Related Side Effects and Adverse Reactions
mesh term: Sufentanil
mesh term: Propofol
mesh term: Desflurane