<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/NCT01704092</url>
  </required_header>
  <id_info>
    <org_study_id>2012001</org_study_id>
    <nct_id>NCT01704092</nct_id>
  </id_info>
  <brief_title>Dexmedetomidine's Cardiac and Cognitive Influence on Patients Undergoing Off-pump Coronary Artery Bypass Graft Surgery</brief_title>
  <official_title>Dexmedetomidine's Cardiac and Cognitive Influence on Patients Undergoing Off-pump Coronary Artery Bypass Graft Surgery</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>
      The investigators hypothesized that dexmedetomidine as an anesthetic adjunct can be used in&#xD;
      the setting of off-pump coronary bypass procedure and can provide benefits to cardiac&#xD;
      function and cognitive performance on the ground of the dexmedetomidine's characteristics.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The emergence of off-pump coronary artery bypass grafting (OPCAB) procedure brings up new&#xD;
      challenges to anesthesiologists and urges us to contemplate the choice of anesthetics. In&#xD;
      face of these challenges Dexmedetomdine with multiple unique traits can readily fit into this&#xD;
      situation.&#xD;
&#xD;
      Off-pump coronary artery bypass (OPCAB) procedure is an emerging procedure which might bring&#xD;
      benefit to patients in comparison with conventional CABGs although final words about outcomes&#xD;
      haven't been reached on the basis of recent literature. However, OPCAB technique definitely&#xD;
      requires more involvement of anesthesiologists especially in cases where hemodynamic&#xD;
      compromise is usually inevitable during anastomosis of Lcx or PDA and early extubation in the&#xD;
      OR is expected1. Thus, the investigators are encountered with more intraoperative challenges&#xD;
      caused by OPCAB than routine CABGs. Concerning about challenges the investigators might take&#xD;
      on, the investigators shall not only pay more attention to surgeons' manipulation but also&#xD;
      review anesthetics that the investigators have selected to find an optimal plan to minimize&#xD;
      adverse effects on heart and other important organs. With this perspective, dexmedetomidine&#xD;
      come into our sight with its peculiar traits of hemodynamic effects and assumed cardiac&#xD;
      protective effects.&#xD;
&#xD;
      Dexmedetomidine as a more selective α2-adrenoreceptor agonist than clonidine has gradually&#xD;
      gain popularity in anesthetic and ICU settings for its unique pharmacologic characteristics.&#xD;
      Dexmedetomidine provides sufficient sedative effects with minimal respiratory effect and then&#xD;
      reduces the consumption of other sedative and antinociceptive drugs.Given specific&#xD;
      requirements of OPCAB surgery, dexmedetomidine's may be more suitable in varying aspects.&#xD;
      Firstly, dexmedetomine can dramatically diminish the level of serum catecholamine (CA). As&#xD;
      the investigators know, the diminished level of catecholamine indicates less stress response&#xD;
      to surgical stimuli and lower incidence of cardiac events. Secondly, the relatively slower HR&#xD;
      by dexmedetomidine can decrease oxygen consumption of myocardium and consequently improve the&#xD;
      perfusion of endangered ischemic area. In addition, the decreased HR which is assumably&#xD;
      analogous to effects of esmolol or other β-blockers can reduce the occurrence of tachycardia&#xD;
      and minimize the motion of heart when &quot;bypass&quot; procedure is performed on the target vessels.&#xD;
      Thirdly, it has been reported that dexmedetomidine can alleviate sufferings of renal function&#xD;
      during major thoracic surgery .Thus, it is implied that dexmedetomidine might in the similar&#xD;
      way ameliorate the damage to renal system caused by hours of stress response and havoc of&#xD;
      SIRS ,and then improve clinical prognosis . In view of assumptions the investigators have&#xD;
      proposed on the ground of dexmedetomidine's characteristics and specific requirements of&#xD;
      OPCAB surgery, the investigators are expecting that dexmdetomidine can fit the situation&#xD;
      where patients' limited capacity of coronary artery and sophisticated pathophysiological&#xD;
      courses have to be taken into account.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date>May 2012</start_date>
  <completion_date type="Anticipated">March 2013</completion_date>
  <primary_completion_date type="Anticipated">December 2012</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>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>cardioprective results represented by serial determination of troponin I (cTnI) cardioprective results represented by serial determination of troponin I (cTnI)</measure>
    <time_frame>up to 3 days after the surgery</time_frame>
    <description>The parameter measured is dynamic so that it is needed to detect the level at different time points</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Hemodynamic values</measure>
    <time_frame>from baseline to the end of the surgery</time_frame>
    <description>On the basis of our experience, the period from baseline to the end of the surgery is five hours on average and would depend on the complexity of the surgical procedure</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Serum level of β-amyloid protein</measure>
    <time_frame>up to 3 days after the surgery</time_frame>
    <description>The study is going to reflect the degree of central nerve system damage by detecting the level of S100 protein in serum. The serum level of S100 is preferred rather than the CSF sample because the approach of CSF sample obtaining is invasive and costly.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Serum level of S100 protein</measure>
    <time_frame>up to 3 days after the surgical procedure</time_frame>
    <description>The study is going to reflect the degree of central nerve system damage by detecting the level of S100 protein in serum. The serum level of S100 is preferred rather than the CSF sample because the approach of CSF sample obtaining is invasive and costly.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>intraoperative and postoperative urine output (UO), extubation time (ET), length of stay in ICU(LOSICU ) and length of hospital stay (LOS)</measure>
    <time_frame>participants will be followed for the duration of hospital stay, an expected average of4 weeks</time_frame>
    <description>The intraoperative and postoperative urine output (UO), extubation time (ET), length of stay in ICU(LOSICU ) are measured in ICU while the length of hospital stay is recorded at the discharge of every patient.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mini-mental state examination(MMSE) scoring</measure>
    <time_frame>up to patients' discharge from hospital</time_frame>
    <description>The study is planned to detect the cognitive performance with this commonly used cognitive evaluation scoring</description>
  </secondary_outcome>
  <number_of_groups>3</number_of_groups>
  <enrollment type="Anticipated">90</enrollment>
  <condition>Coronary Artery Disease</condition>
  <arm_group>
    <arm_group_label>Group High-dose</arm_group_label>
    <description>Dexmedetomidine loading dose 1μg/kg Dexmedetomidine maintenance dose 0.6μg/kg/h</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Group Low-dose</arm_group_label>
    <description>Dexmedetomidine loading dose 0.6μg/kg Dexmedetomidine maintenance dose 0.3μg/kg/h</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Group Control</arm_group_label>
    <description>Dexmedetomidine loading dose and Dexmedetomidine maintenance dose were placed with the same amount of 0.9% saline as placebo</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Dexmedetomidine</intervention_name>
    <arm_group_label>Group Control</arm_group_label>
    <arm_group_label>Group High-dose</arm_group_label>
    <arm_group_label>Group Low-dose</arm_group_label>
  </intervention>
  <biospec_retention>Samples With DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      blood samples are drawn from patients recruited into the study. We planned to draw blood&#xD;
      samples from patients with their consent through the central line.&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        Patients who are planned to undergo off-pump coronary bypass surgery&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  American Society of Anesthesiologists (ASA) scores are between classⅡand Ⅲ&#xD;
&#xD;
          -  undergo off-pump coronary artery bypass grafting (OPCAB)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  left ventricular ejection fraction &lt;40%&#xD;
&#xD;
          -  left ventricular aneurysm&#xD;
&#xD;
          -  acute myocardial infarction in latest two weeks&#xD;
&#xD;
          -  atrial fibrillation&#xD;
&#xD;
          -  associated vascular diseases&#xD;
&#xD;
          -  severe systemic diseases involving the renal and hepatic systems&#xD;
&#xD;
          -  respiratory disease( forced vital capacity less than 50% of predicted values )&#xD;
             preoperative left bundle branch block .&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>35 Years</minimum_age>
    <maximum_age>75 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Ailin Luo, professor</last_name>
    <phone>13507122565</phone>
    <email>alluo@tjh.tjmu.edu.cn</email>
  </overall_contact>
  <location>
    <facility>
      <name>Department of Anesthesiology ,Tongji Hospital, 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>
    <investigator>
      <last_name>Xin Chen, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>October 2012</verification_date>
  <study_first_submitted>October 1, 2012</study_first_submitted>
  <study_first_submitted_qc>October 9, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 11, 2012</study_first_posted>
  <last_update_submitted>October 26, 2012</last_update_submitted>
  <last_update_submitted_qc>October 26, 2012</last_update_submitted_qc>
  <last_update_posted type="Estimate">October 30, 2012</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>MD, Principal Investigator, Undergraduate</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Coronary Artery Disease</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Dexmedetomidine</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/NCT01704092
org study id: 2012001
nct id: NCT01704092
lead sponsor: 
has dmc: Yes
The investigators hypothesized that dexmedetomidine as an anesthetic adjunct can be used in
      the setting of off-pump coronary bypass procedure and can provide benefits to cardiac
      function and cognitive performance on the ground of the dexmedetomidine's characteristics.
The emergence of off-pump coronary artery bypass grafting (OPCAB) procedure brings up new
      challenges to anesthesiologists and urges us to contemplate the choice of anesthetics. In
      face of these challenges Dexmedetomdine with multiple unique traits can readily fit into this
      situation.

      Off-pump coronary artery bypass (OPCAB) procedure is an emerging procedure which might bring
      benefit to patients in comparison with conventional CABGs although final words about outcomes
      haven't been reached on the basis of recent literature. However, OPCAB technique definitely
      requires more involvement of anesthesiologists especially in cases where hemodynamic
      compromise is usually inevitable during anastomosis of Lcx or PDA and early extubation in the
      OR is expected1. Thus, the investigators are encountered with more intraoperative challenges
      caused by OPCAB than routine CABGs. Concerning about challenges the investigators might take
      on, the investigators shall not only pay more attention to surgeons' manipulation but also
      review anesthetics that the investigators have selected to find an optimal plan to minimize
      adverse effects on heart and other important organs. With this perspective, dexmedetomidine
      come into our sight with its peculiar traits of hemodynamic effects and assumed cardiac
      protective effects.

      Dexmedetomidine as a more selective α2-adrenoreceptor agonist than clonidine has gradually
      gain popularity in anesthetic and ICU settings for its unique pharmacologic characteristics.
      Dexmedetomidine provides sufficient sedative effects with minimal respiratory effect and then
      reduces the consumption of other sedative and antinociceptive drugs.Given specific
      requirements of OPCAB surgery, dexmedetomidine's may be more suitable in varying aspects.
      Firstly, dexmedetomine can dramatically diminish the level of serum catecholamine (CA). As
      the investigators know, the diminished level of catecholamine indicates less stress response
      to surgical stimuli and lower incidence of cardiac events. Secondly, the relatively slower HR
      by dexmedetomidine can decrease oxygen consumption of myocardium and consequently improve the
      perfusion of endangered ischemic area. In addition, the decreased HR which is assumably
      analogous to effects of esmolol or other β-blockers can reduce the occurrence of tachycardia
      and minimize the motion of heart when "bypass" procedure is performed on the target vessels.
      Thirdly, it has been reported that dexmedetomidine can alleviate sufferings of renal function
      during major thoracic surgery .Thus, it is implied that dexmedetomidine might in the similar
      way ameliorate the damage to renal system caused by hours of stress response and havoc of
      SIRS ,and then improve clinical prognosis . In view of assumptions the investigators have
      proposed on the ground of dexmedetomidine's characteristics and specific requirements of
      OPCAB surgery, the investigators are expecting that dexmdetomidine can fit the situation
      where patients' limited capacity of coronary artery and sophisticated pathophysiological
      courses have to be taken into account.
observational model: Case-Control
time perspective: Prospective
measure: cardioprective results represented by serial determination of troponin I (cTnI) cardioprective results represented by serial determination of troponin I (cTnI)
time frame: up to 3 days after the surgery
description: The parameter measured is dynamic so that it is needed to detect the level at different time points
measure: Hemodynamic values
time frame: from baseline to the end of the surgery
description: On the basis of our experience, the period from baseline to the end of the surgery is five hours on average and would depend on the complexity of the surgical procedure
measure: Serum level of β-amyloid protein
time frame: up to 3 days after the surgery
description: The study is going to reflect the degree of central nerve system damage by detecting the level of S100 protein in serum. The serum level of S100 is preferred rather than the CSF sample because the approach of CSF sample obtaining is invasive and costly.
measure: Serum level of S100 protein
time frame: up to 3 days after the surgical procedure
description: The study is going to reflect the degree of central nerve system damage by detecting the level of S100 protein in serum. The serum level of S100 is preferred rather than the CSF sample because the approach of CSF sample obtaining is invasive and costly.
measure: intraoperative and postoperative urine output (UO), extubation time (ET), length of stay in ICU(LOSICU ) and length of hospital stay (LOS)
time frame: participants will be followed for the duration of hospital stay, an expected average of4 weeks
description: The intraoperative and postoperative urine output (UO), extubation time (ET), length of stay in ICU(LOSICU ) are measured in ICU while the length of hospital stay is recorded at the discharge of every patient.
measure: Mini-mental state examination(MMSE) scoring
time frame: up to patients' discharge from hospital
description: The study is planned to detect the cognitive performance with this commonly used cognitive evaluation scoring
arm group label: Group High-dose
description: Dexmedetomidine loading dose 1μg/kg Dexmedetomidine maintenance dose 0.6μg/kg/h
arm group label: Group Low-dose
description: Dexmedetomidine loading dose 0.6μg/kg Dexmedetomidine maintenance dose 0.3μg/kg/h
arm group label: Group Control
description: Dexmedetomidine loading dose and Dexmedetomidine maintenance dose were placed with the same amount of 0.9% saline as placebo
intervention type: Drug
intervention name: Dexmedetomidine
arm group label: Group Control
arm group label: Group High-dose
arm group label: Group Low-dose
blood samples are drawn from patients recruited into the study. We planned to draw blood
      samples from patients with their consent through the central line.
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 35 Years
maximum age: 75 Years
healthy volunteers: No
last name: Ailin Luo, professor
phone: 13507122565
email: alluo@tjh.tjmu.edu.cn
facility: 
status: Recruiting
investigator: 
country: China
responsible party type: Principal Investigator
investigator affiliation: Huazhong University of Science and Technology
investigator full name: Xin Chen
investigator title: MD, Principal Investigator, Undergraduate
mesh term: Coronary Artery Disease
mesh term: Dexmedetomidine