<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/NCT03788538</url>
  </required_header>
  <id_info>
    <org_study_id>20181224</org_study_id>
    <nct_id>NCT03788538</nct_id>
  </id_info>
  <brief_title>Effects of Dexmedetomidine on Modulation of Perioperative Blood Glucose and Related Hormones</brief_title>
  <official_title>Effects of Dexmedetomidine on Modulation of Perioperative Blood Glucose and Related Hormones</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Zhuan Zhang</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Yangzhou University</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      The investigators aimed to explore effects of dexmedetomidine on modulation of perioperative&#xD;
      blood glucose and relevant hormone during the general anesthesia with surgery time ≥ 4 hours,&#xD;
      and the effects on postoperative complications. 75 participants (American Society of&#xD;
      Anesthesiologists grades I or II, of both sexes,aged 40-80 yr,with BMI of 18.5-27 kg/m2)&#xD;
      scheduled for elective surgery under general anesthesia with surgery time ≥ 4 hours were&#xD;
      enrolled in this study. The participants were divided into four groups: group C (control&#xD;
      saline group, no dexmedetomidine use), group D1 (dexmedetomidine loading dose 1 mcg/kg,&#xD;
      maintenance dose 0.25 mcg/kg/h), group D2 (dexmedetomidine loading dose 1 mcg/kg, maintenance&#xD;
      dose 0.5 mcg/kg/h).10 minutes before anesthesia induction, all participants were&#xD;
      administrated with dexmedetomidine 1 μg/kg/min.At the beginning of induction, dexmedetomidine&#xD;
      was changed to corresponding maintenance dose in each group. Blood samples were taken at the&#xD;
      beginning of dexmedetomidine (T0), the beginning of skin incision (T1), 1 h after skin&#xD;
      incision (T2), the end of the surgery (T3) and 1 h after patient transfer to PACU (T4) for&#xD;
      the value of blood glucose,lactate and relevant hormones. Also, investigators also record the&#xD;
      total amount of propofol and sufentanil at the end of surgery,and the complications within 24&#xD;
      h after the surgery.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">November 1, 2017</start_date>
  <completion_date type="Actual">June 1, 2020</completion_date>
  <primary_completion_date type="Actual">June 1, 2020</primary_completion_date>
  <phase>N/A</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>Triple (Participant, Care Provider, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Effects of dexmedetomidine on perioperative blood glucose (mmol/L)</measure>
    <time_frame>before dexmedetomidine infusion, 1 hour after incision, at the end of surgery, 1 hour after patient transfer to postanesthesia care unit..</time_frame>
    <description>The changes of blood glucose during the surgery period</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Effects of dexmedetomidine on perioperative insulin (μIU/ml)</measure>
    <time_frame>before dexmedetomidine infusion, 1 hour after incision, at the end of surgery, 1 hour after patient transfer to postanesthesia care unit.</time_frame>
    <description>The changes of insulin during the surgery period</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Effects of dexmedetomidine on perioperative glucagon and catecholamine (pg/ml)</measure>
    <time_frame>before dexmedetomidine infusion, 1 hour after incision, at the end of surgery, 1 hour after patient transfer to postanesthesia care unit.</time_frame>
    <description>The changes of glucagon and catecholamine during the surgery period</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Effects of dexmedetomidine on perioperative cortisol (ng/ml)</measure>
    <time_frame>before dexmedetomidine infusion, 1 hour after incision, at the end of surgery, 1 hour after patient transfer to postanesthesia care unit.</time_frame>
    <description>The changes of cortisol during the surgery period</description>
  </primary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">75</enrollment>
  <condition>Dexmedetomidine</condition>
  <condition>Blood Glucose</condition>
  <arm_group>
    <arm_group_label>group 1 with no dexmedetomidine</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>group 2 with dexmedetomidine 0.25μg/kg/h</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>group 2 with dexmedetomidine 0.5μg/kg/h</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>dexmedetomidine</intervention_name>
    <description>10 minutes before anesthesia induction, all patients were administrated with dexmedetomidine 1 μg/kg/min.At the beginning of induction, dexmedetomidine was changed to corresponding maintenance dose in each group.</description>
    <arm_group_label>group 2 with dexmedetomidine 0.25μg/kg/h</arm_group_label>
    <arm_group_label>group 2 with dexmedetomidine 0.5μg/kg/h</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        - patients undergoing operations over 4 h under general anesthesia,ASA physical status I or&#xD;
        II, irrespective of showing gender bias, aged between 50-75 years old, and having a body&#xD;
        mass index (BMI) between 18.5-28 kg/m2.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  the patients with bradycardia, hypoglycemia, heart disease, adrenal tumor,diabetes or&#xD;
             showed ≥7.0 mmol/L, or HbA1c level ≥6.5%.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>40 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>the Affiliated Hospital of Yangzhou University, Yangzhou University</name>
      <address>
        <city>Yangzhou</city>
        <state>Jiangsu</state>
        <zip>225012</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>January 2021</verification_date>
  <study_first_submitted>December 25, 2018</study_first_submitted>
  <study_first_submitted_qc>December 26, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 27, 2018</study_first_posted>
  <last_update_submitted>January 29, 2021</last_update_submitted>
  <last_update_submitted_qc>January 29, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">February 3, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>Yangzhou University</investigator_affiliation>
    <investigator_full_name>Zhuan Zhang</investigator_full_name>
    <investigator_title>Clinical Professor</investigator_title>
  </responsible_party>
  <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/NCT03788538
org study id: 20181224
nct id: NCT03788538
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
is us export: No
The investigators aimed to explore effects of dexmedetomidine on modulation of perioperative
      blood glucose and relevant hormone during the general anesthesia with surgery time ≥ 4 hours,
      and the effects on postoperative complications. 75 participants (American Society of
      Anesthesiologists grades I or II, of both sexes,aged 40-80 yr,with BMI of 18.5-27 kg/m2)
      scheduled for elective surgery under general anesthesia with surgery time ≥ 4 hours were
      enrolled in this study. The participants were divided into four groups: group C (control
      saline group, no dexmedetomidine use), group D1 (dexmedetomidine loading dose 1 mcg/kg,
      maintenance dose 0.25 mcg/kg/h), group D2 (dexmedetomidine loading dose 1 mcg/kg, maintenance
      dose 0.5 mcg/kg/h).10 minutes before anesthesia induction, all participants were
      administrated with dexmedetomidine 1 μg/kg/min.At the beginning of induction, dexmedetomidine
      was changed to corresponding maintenance dose in each group. Blood samples were taken at the
      beginning of dexmedetomidine (T0), the beginning of skin incision (T1), 1 h after skin
      incision (T2), the end of the surgery (T3) and 1 h after patient transfer to PACU (T4) for
      the value of blood glucose,lactate and relevant hormones. Also, investigators also record the
      total amount of propofol and sufentanil at the end of surgery,and the complications within 24
      h after the surgery.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: Triple (Participant, Care Provider, Investigator)
measure: Effects of dexmedetomidine on perioperative blood glucose (mmol/L)
time frame: before dexmedetomidine infusion, 1 hour after incision, at the end of surgery, 1 hour after patient transfer to postanesthesia care unit..
description: The changes of blood glucose during the surgery period
measure: Effects of dexmedetomidine on perioperative insulin (μIU/ml)
time frame: before dexmedetomidine infusion, 1 hour after incision, at the end of surgery, 1 hour after patient transfer to postanesthesia care unit.
description: The changes of insulin during the surgery period
measure: Effects of dexmedetomidine on perioperative glucagon and catecholamine (pg/ml)
time frame: before dexmedetomidine infusion, 1 hour after incision, at the end of surgery, 1 hour after patient transfer to postanesthesia care unit.
description: The changes of glucagon and catecholamine during the surgery period
measure: Effects of dexmedetomidine on perioperative cortisol (ng/ml)
time frame: before dexmedetomidine infusion, 1 hour after incision, at the end of surgery, 1 hour after patient transfer to postanesthesia care unit.
description: The changes of cortisol during the surgery period
arm group label: group 1 with no dexmedetomidine
arm group type: No Intervention
arm group label: group 2 with dexmedetomidine 0.25μg/kg/h
arm group type: Experimental
arm group label: group 2 with dexmedetomidine 0.5μg/kg/h
arm group type: Experimental
intervention type: Drug
intervention name: dexmedetomidine
description: 10 minutes before anesthesia induction, all patients were administrated with dexmedetomidine 1 μg/kg/min.At the beginning of induction, dexmedetomidine was changed to corresponding maintenance dose in each group.
arm group label: group 2 with dexmedetomidine 0.25μg/kg/h
arm group label: group 2 with dexmedetomidine 0.5μg/kg/h
criteria: 
gender: All
minimum age: 40 Years
maximum age: 80 Years
healthy volunteers: No
facility: 
country: China
responsible party type: Sponsor-Investigator
investigator affiliation: Yangzhou University
investigator full name: Zhuan Zhang
investigator title: Clinical Professor
mesh term: Dexmedetomidine