<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/NCT03809182</url>
  </required_header>
  <id_info>
    <org_study_id>Dexmedetomidine and glycemia.</org_study_id>
    <nct_id>NCT03809182</nct_id>
  </id_info>
  <brief_title>Effect of Dexmedetomidine on Postoperative Glucose and Insulin Levels.</brief_title>
  <official_title>Effect of Dexmedetomidine on Postoperative Glucose Levels and Insulin Secretion Patterns in Obese Patients With Impaired Glucose Tolerance.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Pontificia Universidad Catolica de Chile</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Pontificia Universidad Catolica de Chile</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study investigated the effect of dexmedetomidine in obese patients undergoing bariatric&#xD;
      surgery.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      A prospective, double-blind, randomized controlled trial was performed. Consenting obese&#xD;
      adult patients with impaired glucose tolerance, undergoing bariatric surgery, were&#xD;
      randomized, by a computer, to receive placebo (0.9% Sodium-chloride) or dexmedetomidine 1&#xD;
      ug/kg bolus in 10 minutes followed by an infusion of 0.5 ug/kg/h until the end of surgery.&#xD;
      Baseline HgbA1c, glucose, and insulin plasmatic levels were measured. Subsequently, glucose&#xD;
      and insulin levels were taken every 2 hours during the first 12 hours from the onset of the&#xD;
      drug infusion. Intraoperative fentanyl and postoperative morphine consumption, pain score,&#xD;
      the occurrence of emesis, and postoperative sedation levels were recorded as secondary&#xD;
      outcomes.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">September 27, 2012</start_date>
  <completion_date type="Actual">July 25, 2013</completion_date>
  <primary_completion_date type="Actual">July 25, 2013</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>
    <intervention_model_description>Prospective, randomized, placebo-controlled trial</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
    <masking_description>Blinded</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Plasmatic Glucose Levels (mg/dl).</measure>
    <time_frame>Baseline levels(T0) and at hour 2(T1), 4(T2), 6(T3), 8(T4), 10(T5), and 12(T6) after the onset of bolus and infusion of dexmedetomidine</time_frame>
    <description>Change of baseline glucose levels within the first 12 postoperative hours.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Plasmatic Insulin Levels (uU/ml).</measure>
    <time_frame>Baseline levels(T0) and at hour 2(T1), 4(T2), 6(T3), 8(T4), 10(T5), and 12(T6) after the onset of bolus and infusion of dexmedetomidine</time_frame>
    <description>Change of baseline insulin levels within the first 12 postoperative hours.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Fentanyl Consumption.</measure>
    <time_frame>Since the beginning of anesthesia until the end of it, an average of one hour and a half.</time_frame>
    <description>Amount of fentanyl (ug/kg) intraoperatively administered.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Amount (mg) of Morphine Consumed.</measure>
    <time_frame>At 24h postoperative hours.</time_frame>
    <description>Morphine consumption in the first 24 postoperative hours.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Pain Scores in the First 24 Postoperative Hours.</measure>
    <time_frame>At postoperative hours 2(T1), 4(T2), 6(T3), 8(T4), 10(T5), 12(T6) and 24(T7).</time_frame>
    <description>Visual analogue scale (VAS), provided by patients, ranging from 0 to 10 (0= no pain and 10= worst possible pain). We considered a pain score between 1-3, 4-6 and 7-10 as mild, moderate and severe pain, respectively.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Sedation-agitation Scores in the First 12 Postoperative Hours.</measure>
    <time_frame>At postoperative hours 2(T1), 4(T2), 6(T3), 8(T4), 10(T5) and 12(T6).</time_frame>
    <description>Sedation-agitation scale (SAS), ranging from 1 to 7 (1=unarousable, 2=very sedated, 3=sedated, 4=calm and cooperative, 5=agitated, 6=very agitated and 7=dangerous agitation).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Postoperative Nausea and Vomiting.</measure>
    <time_frame>Postoperative nausea and vomiting during the first 12 postoperative hours.</time_frame>
    <description>Number of patients with postoperative nausea and vomiting in the first 12 postoperative hours.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">40</enrollment>
  <condition>Bariatric Surgery Candidate</condition>
  <condition>Glucose Intolerance</condition>
  <condition>Insulin Resistance</condition>
  <arm_group>
    <arm_group_label>Dexmedetomidine</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>After anesthesia induction, patients who were randomized to the Dexmedetomidine group received a bolus of 1ug/kg in 10 minutes, followed by an infusion of 0.5ug/kg/h until the end of surgery. In the case of intraoperative increment of the blood pressure and/or heart rate more than 25% from its baseline, fentanyl 1ug/kg was administered.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>0.9% Sodium-chloride</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>After anesthesia induction, patients who were randomized to the Placebo group received a bolus and infusion of 0.9% normal saline at the same rate as the Dexmedetomidine group until the end of surgery. In the case of intraoperative increment of the blood pressure and/or heart rate more than 25% from its baseline, fentanyl 1ug/kg was administered.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Dexmedetomidine</intervention_name>
    <description>A bolus of 1ug/kg in 10 minutes, followed by an infusion of 0.5ug/kg/h until the end of surgery.</description>
    <arm_group_label>Dexmedetomidine</arm_group_label>
    <other_name>Precedex</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>0.9% Sodium-chloride</intervention_name>
    <description>The same infusion rate used in the dexmedetomidine group.</description>
    <arm_group_label>0.9% Sodium-chloride</arm_group_label>
    <other_name>Normal saline</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Fentanyl</intervention_name>
    <description>Intraoperative fentanyl was given in case of 25% increment in the blood pressure and/or heart rate in comparison to baseline (previous anesthesia induction).</description>
    <arm_group_label>0.9% Sodium-chloride</arm_group_label>
    <arm_group_label>Dexmedetomidine</arm_group_label>
    <other_name>Sublimaze</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Morphine Sulfate</intervention_name>
    <description>Boluses of 3mg of intravenous morphine were given in the postoperative acute care unit. Once the pain score was equal or less than 3/10 the patient-controlled analgesia pumps were installed and the patients were discharged to their room.</description>
    <arm_group_label>0.9% Sodium-chloride</arm_group_label>
    <arm_group_label>Dexmedetomidine</arm_group_label>
    <other_name>Morphine</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Obese patient (BMI&gt;30)&#xD;
&#xD;
          -  American Society of Anesthesiologists grades II or III&#xD;
&#xD;
          -  Diagnosis of impaired glucose tolerance&#xD;
&#xD;
          -  Undergoing sleeve gastrectomy&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Baseline glucose &gt; 200mg/dl&#xD;
&#xD;
          -  Diagnosis of Diabetes&#xD;
&#xD;
          -  Under corticosteroids treatment&#xD;
&#xD;
          -  Oral hypoglycemic medication within 7 days previous surgery&#xD;
&#xD;
          -  Use of insulin within 24h previous surgery&#xD;
&#xD;
          -  Allergy to any drug used in the study&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>60 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Mauricio Ibacache, MD, PhD</last_name>
    <role>Study Director</role>
    <affiliation>Pontificia Universidad Catolica de Chile</affiliation>
  </overall_official>
  <verification_date>September 2020</verification_date>
  <study_first_submitted>December 30, 2018</study_first_submitted>
  <study_first_submitted_qc>January 17, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 18, 2019</study_first_posted>
  <results_first_submitted>December 8, 2019</results_first_submitted>
  <results_first_submitted_qc>September 9, 2020</results_first_submitted_qc>
  <results_first_posted type="Actual">October 1, 2020</results_first_posted>
  <last_update_submitted>September 9, 2020</last_update_submitted>
  <last_update_submitted_qc>September 9, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">October 1, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Pontificia Universidad Catolica de Chile</investigator_affiliation>
    <investigator_full_name>Eduardo Vega</investigator_full_name>
    <investigator_title>Instructor</investigator_title>
  </responsible_party>
  <keyword>Impaired Glucose Tolerance</keyword>
  <keyword>Obese patients</keyword>
  <keyword>Dexmedetomidine</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Insulin Resistance</mesh_term>
    <mesh_term>Glucose Intolerance</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Fentanyl</mesh_term>
    <mesh_term>Dexmedetomidine</mesh_term>
    <mesh_term>Morphine</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>

  <clinical_results>

    <participant_flow>
      <recruitment_details>The patients were recruited at the Pontifical Catholic University Hospital between 2012 and 2013. Twenty patients were assigned to each arm to allow some dropouts. Nonetheless, every randomized patient included in the study was analyzed at the end of it (intention to treat analysis).</recruitment_details>
      <pre_assignment_details>No patient was excluded from the study after being assigned to one arm/group.</pre_assignment_details>
      <group_list>
        <group group_id="P1">
          <title>Dexmedetomidine</title>
          <description>After anesthesia induction, patients who were randomized to the Dexmedetomidine group received:&#xD;
Dexmedetomidine: A bolus of 1ug/kg in 10 minutes, followed by an infusion of 0.5ug/kg/h until the end of surgery.&#xD;
Fentanyl: Intraoperative fentanyl was given in case of 25% increment in the blood pressure and/or heart rate in comparison to baseline (previous anesthesia induction).&#xD;
Morphine Sulfate: Boluses of 3mg of intravenous morphine were given in the postoperative acute care unit. Once the pain score was equal or less than 3/10 the patient-controlled analgesia pumps were installed and the patients were discharged to their room.</description>
        </group>
        <group group_id="P2">
          <title>0.9% Sodium-chloride</title>
          <description>After anesthesia induction, patients who were randomized to the Placebo group received:&#xD;
0.9% Sodium-chloride: The same bolus and infusion rate used in the dexmedetomidine group.&#xD;
Fentanyl: Intraoperative fentanyl was given in case of 25% increment in the blood pressure and/or heart rate in comparison to baseline (previous anesthesia induction).&#xD;
Morphine Sulfate: Boluses of 3mg of intravenous morphine were given in the postoperative acute care unit. Once the pain score was equal or less than 3/10 the patient-controlled analgesia pumps were installed and the patients were discharged to their room.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="20"/>
                <participants group_id="P2" count="20"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="20"/>
                <participants group_id="P2" count="20"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <population>Baseline characteristics from the entire study population were measured.</population>
      <group_list>
        <group group_id="B1">
          <title>Dexmedetomidine</title>
          <description>After anesthesia induction, patients who were randomized to the Dexmedetomidine group, received a bolus of 1ug/kg in 10 minutes, followed by an infusion of 0.5ug/kg/h until the end of surgery. In the case of intraoperative increment of the blood pressure and/or heart rate more than 25% from its baseline, fentanyl 1ug/kg was administered.&#xD;
Dexmedetomidine: A bolus of 1ug/kg in 10 minutes, followed by an infusion of 0.5ug/kg/h until the end of surgery.&#xD;
Fentanyl: Intraoperative fentanyl was given in the case of 25% increment in the blood pressure and/or heart rate in comparison to baseline (previous anesthesia induction).&#xD;
Morphine Sulfate: Boluses of 3mg of intravenous morphine were given in the postoperative acute care unit. Once the pain score was equal or less than 3/10 a patient-controlled analgesia pump was installed and the patient was discharged to his/her room.</description>
        </group>
        <group group_id="B2">
          <title>0.9% Sodium-chloride</title>
          <description>After anesthesia induction, patients who were randomized to the Placebo group received a bolus and infusion of 0.9% normal saline at the same rate as the Dexmedetomidine group until the end of surgery. In the case of intraoperative increment of the blood pressure and/or heart rate more than 25% from its baseline, fentanyl 1ug/kg was administered.&#xD;
0.9% Sodium-chloride: The same dose used in the dexmedetomidine group (bolus and infusion).&#xD;
Fentanyl: Intraoperative fentanyl was given in the case of 25% increment in the blood pressure and/or heart rate in comparison to baseline (previous anesthesia induction).&#xD;
Morphine Sulfate: Boluses of 3mg of intravenous morphine were given in the postoperative acute care unit. Once the pain score was equal or less than 3/10 a patient-controlled analgesia pump was installed and the patient was discharged to his/her room.</description>
        </group>
        <group group_id="B3">
          <title>Total</title>
          <description>Total of all reporting groups</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="20"/>
            <count group_id="B2" value="20"/>
            <count group_id="B3" value="40"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>&lt;=18 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Between 18 and 65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="20"/>
                    <measurement group_id="B2" value="20"/>
                    <measurement group_id="B3" value="40"/>
                  </measurement_list>
                </category>
                <category>
                  <title>&gt;=65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="33" spread="10.2"/>
                    <measurement group_id="B2" value="31.5" spread="9.9"/>
                    <measurement group_id="B3" value="32" spread="10"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="20"/>
                    <measurement group_id="B2" value="15"/>
                    <measurement group_id="B3" value="35"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="5"/>
                    <measurement group_id="B3" value="5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Region of Enrollment</title>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>Chile</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="20"/>
                    <measurement group_id="B2" value="20"/>
                    <measurement group_id="B3" value="40"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Body Mass Index (BMI)</title>
          <units>kg/m^2</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="34.4" spread="2.5"/>
                    <measurement group_id="B2" value="35.2" spread="3.6"/>
                    <measurement group_id="B3" value="34.8" spread="3.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>ASA physical status II</title>
          <description>ASA I A normal healthy patient, ASA II A patient with mild systemic disease, ASA III A patient with severe systemic disease, ASA IV A patient with severe systemic disease that is a constant threat to life, ASA V A moribund patient who is not expected to survive without the operation, ASA VI A declared brain-dead patient whose organs are being removed for donor purposes</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="20"/>
                    <measurement group_id="B2" value="20"/>
                    <measurement group_id="B3" value="40"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Risk score for postoperative nausea and vomiting (PONV) in adults</title>
          <description>This corresponds to the Apfel simplified risk score, which is based on 4 predictors: female sex, history of PONV and/or motion sickness, nonsmoking status, and use of postoperative opioids. The higher the number of risk factors the more probable the incidence of PONV.</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>0 risk factor</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>1 risk factor</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="4"/>
                    <measurement group_id="B3" value="4"/>
                  </measurement_list>
                </category>
                <category>
                  <title>2 risk factors</title>
                  <measurement_list>
                    <measurement group_id="B1" value="14"/>
                    <measurement group_id="B2" value="9"/>
                    <measurement group_id="B3" value="23"/>
                  </measurement_list>
                </category>
                <category>
                  <title>3 risk factors</title>
                  <measurement_list>
                    <measurement group_id="B1" value="5"/>
                    <measurement group_id="B2" value="6"/>
                    <measurement group_id="B3" value="11"/>
                  </measurement_list>
                </category>
                <category>
                  <title>4 risk factors</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Baseline HbA1c</title>
          <units>Percentage</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="5.4" spread="0.2"/>
                    <measurement group_id="B2" value="5.4" spread="0.4"/>
                    <measurement group_id="B3" value="5.4" spread="0.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Plasmatic Glucose Levels (mg/dl).</title>
        <description>Change of baseline glucose levels within the first 12 postoperative hours.</description>
        <time_frame>Baseline levels(T0) and at hour 2(T1), 4(T2), 6(T3), 8(T4), 10(T5), and 12(T6) after the onset of bolus and infusion of dexmedetomidine</time_frame>
        <population>All recruited population was analyzed.</population>
        <group_list>
          <group group_id="O1">
            <title>Dexmedetomidine</title>
            <description>After anesthesia induction, patients who were randomized to the Dexmedetomidine group received:&#xD;
Dexmedetomidine: A bolus of 1ug/kg in 10 minutes, followed by an infusion of 0.5ug/kg/h until the end of surgery.&#xD;
Fentanyl: Intraoperative fentanyl was given in case of 25% increment in the blood pressure and/or heart rate in comparison to baseline (previous anesthesia induction).&#xD;
Morphine Sulfate: Boluses of 3mg of intravenous morphine were given in the postoperative acute care unit. Once the pain score was equal or less than 3/10 the patient-controlled analgesia pumps were installed and the patients were discharged to their room.</description>
          </group>
          <group group_id="O2">
            <title>0.9% Sodium-chloride</title>
            <description>After anesthesia induction, patients who were randomized to the Placebo group received:&#xD;
0.9% Sodium-chloride: The same rate infusion used in the dexmedetomidine group (bolus and infusion).&#xD;
Fentanyl: Intraoperative fentanyl was given in case of 25% increment in the blood pressure and/or heart rate in comparison to baseline (previous anesthesia induction).&#xD;
Morphine Sulfate: Boluses of 3mg of intravenous morphine were given in the postoperative acute care unit. Once the pain score was equal or less than 3/10 a patient-controlled analgesia pumps were installed and the patients were discharged to their room.</description>
          </group>
        </group_list>
        <measure>
          <title>Plasmatic Glucose Levels (mg/dl).</title>
          <description>Change of baseline glucose levels within the first 12 postoperative hours.</description>
          <population>All recruited population was analyzed.</population>
          <units>mg/dl</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="20"/>
                <count group_id="O2" value="20"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline level (T0)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="80" spread="15"/>
                    <measurement group_id="O2" value="82" spread="8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Hour 2 (T1)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="114" spread="29"/>
                    <measurement group_id="O2" value="111" spread="20"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Hour 4 (T2)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="124" spread="25"/>
                    <measurement group_id="O2" value="129" spread="17"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Hour 6 (T3)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="131" spread="60"/>
                    <measurement group_id="O2" value="120" spread="16"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Hour 8 (T4)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="122" spread="41"/>
                    <measurement group_id="O2" value="118" spread="17"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Hour 10 (T5)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="130" spread="62"/>
                    <measurement group_id="O2" value="117" spread="18"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Hour 12 (T6)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="125" spread="31"/>
                    <measurement group_id="O2" value="117" spread="17"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Null hypothesis: There is no difference in plasmatic glucose levels between dexmedetomidine and 0.9% sodium-chloride groups.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.38</p_value>
            <p_value_desc>A p-value less than .05 was considered statistically significant.</p_value_desc>
            <method>Mixed Models Analysis</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Plasmatic Insulin Levels (uU/ml).</title>
        <description>Change of baseline insulin levels within the first 12 postoperative hours.</description>
        <time_frame>Baseline levels(T0) and at hour 2(T1), 4(T2), 6(T3), 8(T4), 10(T5), and 12(T6) after the onset of bolus and infusion of dexmedetomidine</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Dexmedetomidine</title>
            <description>After anesthesia induction, patients who were randomized to the Dexmedetomidine group, received a bolus of 1ug/kg in 10 minutes, followed by an infusion of 0.5ug/kg/h until the end of surgery. In case of intraoperative increment of the blood pressure and/or heart rate more than 25% from its baseline, fentanyl 1ug/kg was administered.&#xD;
Dexmedetomidine: A bolus of 1ug/kg in 10 minutes, followed by an infusion of 0.5ug/kg/h until the end of surgery.&#xD;
Fentanyl: Intraoperative fentanyl was given in case of 25% increment in the blood pressure and/or heart rate in comparison to baseline (previous anesthesia induction).&#xD;
Morphine Sulfate: Boluses of 3mg of intravenous morphine were given in the postoperative acute care unit. Once the pain score was equal or less than 3/10 a patient-controlled analgesia pumps were installed and the patients were discharged to their room.</description>
          </group>
          <group group_id="O2">
            <title>0.9% Sodium-chloride</title>
            <description>After anesthesia induction, patients who were randomized to the Placebo group received a bolus and infusion of 0.9% normal saline at the same rate as the Dexmedetomidine group until the end of surgery. In case of intraoperative increment of the blood pressure and/or heart rate more than 25% from its baseline, fentanyl 1ug/kg was administered.&#xD;
0.9% Sodium-chloride: The same dose used in the dexmedetomidine group (bolus and infusion).&#xD;
Fentanyl: Intraoperative fentanyl was given in case of 25% increment in the blood pressure and/or heart rate in comparison to baseline (previous anesthesia induction).&#xD;
Morphine Sulfate: Boluses of 3mg of intravenous morphine were given in the postoperative acute care unit. Once the pain score was equal or less than 3/10 a patient-controlled analgesia pumps were installed and the patients were discharged to their room.</description>
          </group>
        </group_list>
        <measure>
          <title>Plasmatic Insulin Levels (uU/ml).</title>
          <description>Change of baseline insulin levels within the first 12 postoperative hours.</description>
          <units>uU/dl</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="20"/>
                <count group_id="O2" value="20"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline level (T0)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="10.5" spread="6"/>
                    <measurement group_id="O2" value="11.2" spread="6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Hour 2 (T1)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="11.8" spread="9"/>
                    <measurement group_id="O2" value="19.9" spread="11.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Hour 4 (T2)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="16.7" spread="9.5"/>
                    <measurement group_id="O2" value="30.3" spread="19.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Hour 6 (T3)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="16.8" spread="11.4"/>
                    <measurement group_id="O2" value="23" spread="11.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Hour 8 (T4)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="16.6" spread="8.9"/>
                    <measurement group_id="O2" value="21.5" spread="10.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Hour 10 (T5)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="16" spread="10"/>
                    <measurement group_id="O2" value="24" spread="17.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Hour 12 (T6)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="16.6" spread="9.2"/>
                    <measurement group_id="O2" value="25.9" spread="18.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Null hypothesis: There is no difference in insulin levels between dexmedetomidine and 0.9% sodium-chloride groups.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.02</p_value>
            <p_value_desc>A p-value less than .05 was considered statistically significant.</p_value_desc>
            <method>Mixed Models Analysis</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Fentanyl Consumption.</title>
        <description>Amount of fentanyl (ug/kg) intraoperatively administered.</description>
        <time_frame>Since the beginning of anesthesia until the end of it, an average of one hour and a half.</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Dexmedetomidine</title>
            <description>After anesthesia induction, patients who were randomized to the Dexmedetomidine group, received a bolus of 1ug/kg in 10 minutes, followed by an infusion of 0.5ug/kg/h until the end of surgery. In case of intraoperative increment of the blood pressure and/or heart rate more than 25% from its baseline, fentanyl 1ug/kg was administered.&#xD;
Dexmedetomidine: A bolus of 1ug/kg in 10 minutes, followed by an infusion of 0.5ug/kg/h until the end of surgery.&#xD;
Fentanyl: Intraoperative fentanyl was given in case of 25% increment in the blood pressure and/or heart rate in comparison to baseline (previous anesthesia induction).&#xD;
Morphine Sulfate: Boluses of 3mg of intravenous morphine were given in the postoperative acute care unit. Once the pain score was equal or less than 3/10 a patient-controlled analgesia pumps were installed and the patients were discharged to their room.</description>
          </group>
          <group group_id="O2">
            <title>0.9% Sodium-chloride</title>
            <description>After anesthesia induction, patients who were randomized to the Placebo group received a bolus and infusion of 0.9% normal saline at the same rate as the Dexmedetomidine group until the end of surgery. In case of intraoperative increment of the blood pressure and/or heart rate more than 25% from its baseline, fentanyl 1ug/kg was administered.&#xD;
0.9% Sodium-chloride: The same dose used in the dexmedetomidine group (bolus and infusion).&#xD;
Fentanyl: Intraoperative fentanyl was given in case of 25% increment in the blood pressure and/or heart rate in comparison to baseline (previous anesthesia induction).&#xD;
Morphine Sulfate: Boluses of 3mg of intravenous morphine were given in the postoperative acute care unit. Once the pain score was equal or less than 3/10 a patient-controlled analgesia pumps were installed and the patients were discharged to their room.</description>
          </group>
        </group_list>
        <measure>
          <title>Fentanyl Consumption.</title>
          <description>Amount of fentanyl (ug/kg) intraoperatively administered.</description>
          <units>mcg/kg</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="20"/>
                <count group_id="O2" value="20"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6.0" spread="2.2"/>
                    <measurement group_id="O2" value="7" spread="2.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Amount (mg) of Morphine Consumed.</title>
        <description>Morphine consumption in the first 24 postoperative hours.</description>
        <time_frame>At 24h postoperative hours.</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Dexmedetomidine</title>
            <description>After anesthesia induction, patients who were randomized to the Dexmedetomidine group, received a bolus of 1ug/kg in 10 minutes, followed by an infusion of 0.5ug/kg/h until the end of surgery. In case of intraoperative increment of the blood pressure and/or heart rate more than 25% from its baseline, fentanyl 1ug/kg was administered.&#xD;
Dexmedetomidine: A bolus of 1ug/kg in 10 minutes, followed by an infusion of 0.5ug/kg/h until the end of surgery.&#xD;
Fentanyl: Intraoperative fentanyl was given in case of 25% increment in the blood pressure and/or heart rate in comparison to baseline (previous anesthesia induction).&#xD;
Morphine Sulfate: Boluses of 3mg of intravenous morphine were given in the postoperative acute care unit. Once the pain score was equal or less than 3/10 a patient-controlled analgesia pumps were installed and the patients were discharged to their room.</description>
          </group>
          <group group_id="O2">
            <title>0.9% Sodium-chloride</title>
            <description>After anesthesia induction, patients who were randomized to the Placebo group received a bolus and infusion of 0.9% normal saline at the same rate as the Dexmedetomidine group until the end of surgery. In case of intraoperative increment of the blood pressure and/or heart rate more than 25% from its baseline, fentanyl 1ug/kg was administered.&#xD;
0.9% Sodium-chloride: The same dose used in the dexmedetomidine group (bolus and infusion).&#xD;
Fentanyl: Intraoperative fentanyl was given in case of 25% increment in the blood pressure and/or heart rate in comparison to baseline (previous anesthesia induction).&#xD;
Morphine Sulfate: Boluses of 3mg of intravenous morphine were given in the postoperative acute care unit. Once the pain score was equal or less than 3/10 a patient-controlled analgesia pumps were installed and the patients were discharged to their room.</description>
          </group>
        </group_list>
        <measure>
          <title>Amount (mg) of Morphine Consumed.</title>
          <description>Morphine consumption in the first 24 postoperative hours.</description>
          <units>mg</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="20"/>
                <count group_id="O2" value="20"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="26" spread="14.4"/>
                    <measurement group_id="O2" value="18.4" spread="10.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Pain Scores in the First 24 Postoperative Hours.</title>
        <description>Visual analogue scale (VAS), provided by patients, ranging from 0 to 10 (0= no pain and 10= worst possible pain). We considered a pain score between 1-3, 4-6 and 7-10 as mild, moderate and severe pain, respectively.</description>
        <time_frame>At postoperative hours 2(T1), 4(T2), 6(T3), 8(T4), 10(T5), 12(T6) and 24(T7).</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Dexmedetomidine</title>
            <description>After anesthesia induction, patients who were randomized to the Dexmedetomidine group, received a bolus of 1ug/kg in 10 minutes, followed by an infusion of 0.5ug/kg/h until the end of surgery. In case of intraoperative increment of the blood pressure and/or heart rate more than 25% from its baseline, fentanyl 1ug/kg was administered.&#xD;
Dexmedetomidine: A bolus of 1ug/kg in 10 minutes, followed by an infusion of 0.5ug/kg/h until the end of surgery.&#xD;
Fentanyl: Intraoperative fentanyl was given in case of 25% increment in the blood pressure and/or heart rate in comparison to baseline (previous anesthesia induction).&#xD;
Morphine Sulfate: Boluses of 3mg of intravenous morphine were given in the postoperative acute care unit. Once the pain score was equal or less than 3/10 a patient-controlled analgesia pumps were installed and the patients were discharged to their room.</description>
          </group>
          <group group_id="O2">
            <title>0.9% Sodium-chloride</title>
            <description>After anesthesia induction, patients who were randomized to the Placebo group received a bolus and infusion of 0.9% normal saline at the same rate as the Dexmedetomidine group until the end of surgery. In case of intraoperative increment of the blood pressure and/or heart rate more than 25% from its baseline, fentanyl 1ug/kg was administered.&#xD;
0.9% Sodium-chloride: The same dose used in the dexmedetomidine group (bolus and infusion).&#xD;
Fentanyl: Intraoperative fentanyl was given in case of 25% increment in the blood pressure and/or heart rate in comparison to baseline (previous anesthesia induction).&#xD;
Morphine Sulfate: Boluses of 3mg of intravenous morphine were given in the postoperative acute care unit. Once the pain score was equal or less than 3/10 a patient-controlled analgesia pumps were installed and the patients were discharged to their room.</description>
          </group>
        </group_list>
        <measure>
          <title>Pain Scores in the First 24 Postoperative Hours.</title>
          <description>Visual analogue scale (VAS), provided by patients, ranging from 0 to 10 (0= no pain and 10= worst possible pain). We considered a pain score between 1-3, 4-6 and 7-10 as mild, moderate and severe pain, respectively.</description>
          <units>units on a scale</units>
          <param>Median</param>
          <dispersion>Inter-Quartile Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="20"/>
                <count group_id="O2" value="20"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Hour 2 (T1) Pain at rest</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0" lower_limit="0" upper_limit="2"/>
                    <measurement group_id="O2" value="0" lower_limit="0" upper_limit="4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Hour 2 (T1) Pain at movement</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0" lower_limit="0" upper_limit="2"/>
                    <measurement group_id="O2" value="0" lower_limit="0" upper_limit="5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Hour 4 (T2) Pain at rest</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4" lower_limit="2" upper_limit="5"/>
                    <measurement group_id="O2" value="3" lower_limit="2" upper_limit="4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Hour 4 (T2) Pain at movement</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5" lower_limit="4" upper_limit="6"/>
                    <measurement group_id="O2" value="4" lower_limit="3" upper_limit="6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Hour 6 (T3) Pain at rest</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3" lower_limit="1" upper_limit="5"/>
                    <measurement group_id="O2" value="2" lower_limit="2" upper_limit="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Hour 6 (T3) Pain at movement</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4" lower_limit="2" upper_limit="6"/>
                    <measurement group_id="O2" value="4" lower_limit="2" upper_limit="5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Hour 8 (T4) Pain at rest</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3" lower_limit="1" upper_limit="5"/>
                    <measurement group_id="O2" value="1" lower_limit="0" upper_limit="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Hour 8 (T4) Pain at movement</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4" lower_limit="3" upper_limit="7"/>
                    <measurement group_id="O2" value="4" lower_limit="2" upper_limit="4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Hour 10 (T5) Pain at rest</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3" lower_limit="1" upper_limit="4"/>
                    <measurement group_id="O2" value="1" lower_limit="0" upper_limit="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Hour 10 (T5) Pain at movement</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5" lower_limit="3" upper_limit="6"/>
                    <measurement group_id="O2" value="3" lower_limit="2" upper_limit="5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Hour 12 (T6) Pain at rest</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3" lower_limit="0" upper_limit="4"/>
                    <measurement group_id="O2" value="1" lower_limit="0" upper_limit="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Hour 12 (T6) Pain at movement</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3" lower_limit="2" upper_limit="5"/>
                    <measurement group_id="O2" value="3" lower_limit="2" upper_limit="4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Hour 24 (T7) Pain at rest</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2" lower_limit="0" upper_limit="3"/>
                    <measurement group_id="O2" value="0" lower_limit="0" upper_limit="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Hour 24 (T7) Pain at movement</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3" lower_limit="1" upper_limit="4"/>
                    <measurement group_id="O2" value="3" lower_limit="1" upper_limit="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Sedation-agitation Scores in the First 12 Postoperative Hours.</title>
        <description>Sedation-agitation scale (SAS), ranging from 1 to 7 (1=unarousable, 2=very sedated, 3=sedated, 4=calm and cooperative, 5=agitated, 6=very agitated and 7=dangerous agitation).</description>
        <time_frame>At postoperative hours 2(T1), 4(T2), 6(T3), 8(T4), 10(T5) and 12(T6).</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Dexmedetomidine</title>
            <description>After anesthesia induction, patients who were randomized to the Dexmedetomidine group, received a bolus of 1ug/kg in 10 minutes, followed by an infusion of 0.5ug/kg/h until the end of surgery. In case of intraoperative increment of the blood pressure and/or heart rate more than 25% from its baseline, fentanyl 1ug/kg was administered.&#xD;
Dexmedetomidine: A bolus of 1ug/kg in 10 minutes, followed by an infusion of 0.5ug/kg/h until the end of surgery.&#xD;
Fentanyl: Intraoperative fentanyl was given in case of 25% increment in the blood pressure and/or heart rate in comparison to baseline (previous anesthesia induction).&#xD;
Morphine Sulfate: Boluses of 3mg of intravenous morphine were given in the postoperative acute care unit. Once the pain score was equal or less than 3/10 a patient-controlled analgesia pumps were installed and the patients were discharged to their room.</description>
          </group>
          <group group_id="O2">
            <title>0.9% Sodium-chloride</title>
            <description>After anesthesia induction, patients who were randomized to the Placebo group received a bolus and infusion of 0.9% normal saline at the same rate as the Dexmedetomidine group until the end of surgery. In case of intraoperative increment of the blood pressure and/or heart rate more than 25% from its baseline, fentanyl 1ug/kg was administered.&#xD;
0.9% Sodium-chloride: The same dose used in the dexmedetomidine group (bolus and infusion).&#xD;
Fentanyl: Intraoperative fentanyl was given in case of 25% increment in the blood pressure and/or heart rate in comparison to baseline (previous anesthesia induction).&#xD;
Morphine Sulfate: Boluses of 3mg of intravenous morphine were given in the postoperative acute care unit. Once the pain score was equal or less than 3/10 a patient-controlled analgesia pumps were installed and the patients were discharged to their room.</description>
          </group>
        </group_list>
        <measure>
          <title>Sedation-agitation Scores in the First 12 Postoperative Hours.</title>
          <description>Sedation-agitation scale (SAS), ranging from 1 to 7 (1=unarousable, 2=very sedated, 3=sedated, 4=calm and cooperative, 5=agitated, 6=very agitated and 7=dangerous agitation).</description>
          <units>score on a scale</units>
          <param>Median</param>
          <dispersion>Inter-Quartile Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="20"/>
                <count group_id="O2" value="20"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Hour 2 (T1)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3" lower_limit="3" upper_limit="4"/>
                    <measurement group_id="O2" value="4" lower_limit="4" upper_limit="4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Hour 4 (T2)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4" lower_limit="3" upper_limit="4"/>
                    <measurement group_id="O2" value="4" lower_limit="4" upper_limit="4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Hour 6 (T3)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4" lower_limit="4" upper_limit="4"/>
                    <measurement group_id="O2" value="4" lower_limit="4" upper_limit="4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Hour 8 (T4)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4" lower_limit="4" upper_limit="4"/>
                    <measurement group_id="O2" value="4" lower_limit="4" upper_limit="4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Hour 10 (T5)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4" lower_limit="4" upper_limit="4"/>
                    <measurement group_id="O2" value="4" lower_limit="4" upper_limit="4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Hour 12 (T6)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4" lower_limit="4" upper_limit="4"/>
                    <measurement group_id="O2" value="4" lower_limit="4" upper_limit="4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Postoperative Nausea and Vomiting.</title>
        <description>Number of patients with postoperative nausea and vomiting in the first 12 postoperative hours.</description>
        <time_frame>Postoperative nausea and vomiting during the first 12 postoperative hours.</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Dexmedetomidine</title>
            <description>After anesthesia induction, patients who were randomized to the Dexmedetomidine group, received a bolus of 1ug/kg in 10 minutes, followed by an infusion of 0.5ug/kg/h until the end of surgery. In case of intraoperative increment of the blood pressure and/or heart rate more than 25% from its baseline, fentanyl 1ug/kg was administered.&#xD;
Dexmedetomidine: A bolus of 1ug/kg in 10 minutes, followed by an infusion of 0.5ug/kg/h until the end of surgery.&#xD;
Fentanyl: Intraoperative fentanyl was given in case of 25% increment in the blood pressure and/or heart rate in comparison to baseline (previous anesthesia induction).&#xD;
Morphine Sulfate: Boluses of 3mg of intravenous morphine were given in the postoperative acute care unit. Once the pain score was equal or less than 3/10 a patient-controlled analgesia pumps were installed and the patients were discharged to their room.</description>
          </group>
          <group group_id="O2">
            <title>0.9% Sodium-chloride</title>
            <description>After anesthesia induction, patients who were randomized to the Placebo group received a bolus and infusion of 0.9% normal saline at the same rate as the Dexmedetomidine group until the end of surgery. In case of intraoperative increment of the blood pressure and/or heart rate more than 25% from its baseline, fentanyl 1ug/kg was administered.&#xD;
0.9% Sodium-chloride: The same dose used in the dexmedetomidine group (bolus and infusion).&#xD;
Fentanyl: Intraoperative fentanyl was given in case of 25% increment in the blood pressure and/or heart rate in comparison to baseline (previous anesthesia induction).&#xD;
Morphine Sulfate: Boluses of 3mg of intravenous morphine were given in the postoperative acute care unit. Once the pain score was equal or less than 3/10 a patient-controlled analgesia pumps were installed and the patients were discharged to their room.</description>
          </group>
        </group_list>
        <measure>
          <title>Postoperative Nausea and Vomiting.</title>
          <description>Number of patients with postoperative nausea and vomiting in the first 12 postoperative hours.</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="20"/>
                <count group_id="O2" value="20"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="16"/>
                    <measurement group_id="O2" value="19"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>Intraop and 24 hours post-surgery.</time_frame>
      <desc>Record of vital signs was written in the anesthesia sheet.&#xD;
Non-serious adverse events were presented as follow:&#xD;
Hypotension Bradycardia Hypotension associated with bradycardia</desc>
      <group_list>
        <group group_id="E1">
          <title>Dexmedetomidine</title>
          <description>After anesthesia induction, patients who were randomized to the Dexmedetomidine group, received a bolus of 1ug/kg in 10 minutes, followed by an infusion of 0.5ug/kg/h until the end of surgery. In the case of intraoperative increment of the blood pressure and/or heart rate more than 25% from its baseline, fentanyl 1ug/kg was administered.&#xD;
Dexmedetomidine: A bolus of 1ug/kg in 10 minutes, followed by an infusion of 0.5ug/kg/h until the end of surgery.&#xD;
Fentanyl: Intraoperative fentanyl was given in case of 25% increment in the blood pressure and/or heart rate in comparison to baseline (previous anesthesia induction).&#xD;
Morphine Sulfate: Boluses of 3mg of intravenous morphine were given in the postoperative acute care unit. Once the pain score was equal or less than 3/10 a patient-controlled analgesia pumps were installed and the patients were discharged to their room.</description>
        </group>
        <group group_id="E2">
          <title>0.9% Sodium-chloride</title>
          <description>After anesthesia induction, patients who were randomized to the Placebo group received a bolus and infusion of 0.9% normal saline at the same rate as the Dexmedetomidine group until the end of surgery. In the case of intraoperative increment of the blood pressure and/or heart rate more than 25% from its baseline, fentanyl 1ug/kg was administered.&#xD;
0.9% Sodium-chloride: The same dose used in the dexmedetomidine group (bolus and infusion).&#xD;
Fentanyl: Intraoperative fentanyl was given in case of 25% increment in the blood pressure and/or heart rate in comparison to baseline (previous anesthesia induction).&#xD;
Morphine Sulfate: Boluses of 3mg of intravenous morphine were given in the postoperative acute care unit. Once the pain score was equal or less than 3/10 a patient-controlled analgesia pumps were installed and the patients were discharged to their room.</description>
        </group>
      </group_list>
      <serious_events>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="20"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="20"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>5</frequency_threshold>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="17" subjects_at_risk="20"/>
                <counts group_id="E2" subjects_affected="10" subjects_at_risk="20"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Cardiac disorders</title>
            <event_list>
              <event>
                <sub_title>Isolated hypotension</sub_title>
                <description>Isolated hypotension</description>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="20"/>
                <counts group_id="E2" events="4" subjects_affected="4" subjects_at_risk="20"/>
              </event>
              <event>
                <sub_title>Isolated Bradycardia</sub_title>
                <description>Isolated bradycardia</description>
                <counts group_id="E1" events="7" subjects_affected="7" subjects_at_risk="20"/>
                <counts group_id="E2" events="4" subjects_affected="4" subjects_at_risk="20"/>
              </event>
              <event>
                <sub_title>Hypotension associated with bradycardia</sub_title>
                <description>Hypotension and bradycardia combined</description>
                <counts group_id="E1" events="10" subjects_affected="10" subjects_at_risk="20"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="20"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>All Principal Investigators ARE employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed. </restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Mauricio Ibacache MD</name_or_title>
      <organization>Pontificia Universidad Católica de Chile</organization>
      <phone>+56984421425</phone>
      <email>mibacach@med.puc.cl</email>
    </point_of_contact>
  </clinical_results>
</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/NCT03809182
org study id: Dexmedetomidine and glycemia.
nct id: NCT03809182
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
This study investigated the effect of dexmedetomidine in obese patients undergoing bariatric
      surgery.
A prospective, double-blind, randomized controlled trial was performed. Consenting obese
      adult patients with impaired glucose tolerance, undergoing bariatric surgery, were
      randomized, by a computer, to receive placebo (0.9% Sodium-chloride) or dexmedetomidine 1
      ug/kg bolus in 10 minutes followed by an infusion of 0.5 ug/kg/h until the end of surgery.
      Baseline HgbA1c, glucose, and insulin plasmatic levels were measured. Subsequently, glucose
      and insulin levels were taken every 2 hours during the first 12 hours from the onset of the
      drug infusion. Intraoperative fentanyl and postoperative morphine consumption, pain score,
      the occurrence of emesis, and postoperative sedation levels were recorded as secondary
      outcomes.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: Prospective, randomized, placebo-controlled trial
primary purpose: Treatment
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
masking description: Blinded
measure: Plasmatic Glucose Levels (mg/dl).
time frame: Baseline levels(T0) and at hour 2(T1), 4(T2), 6(T3), 8(T4), 10(T5), and 12(T6) after the onset of bolus and infusion of dexmedetomidine
description: Change of baseline glucose levels within the first 12 postoperative hours.
measure: Plasmatic Insulin Levels (uU/ml).
time frame: Baseline levels(T0) and at hour 2(T1), 4(T2), 6(T3), 8(T4), 10(T5), and 12(T6) after the onset of bolus and infusion of dexmedetomidine
description: Change of baseline insulin levels within the first 12 postoperative hours.
measure: Fentanyl Consumption.
time frame: Since the beginning of anesthesia until the end of it, an average of one hour and a half.
description: Amount of fentanyl (ug/kg) intraoperatively administered.
measure: Amount (mg) of Morphine Consumed.
time frame: At 24h postoperative hours.
description: Morphine consumption in the first 24 postoperative hours.
measure: Pain Scores in the First 24 Postoperative Hours.
time frame: At postoperative hours 2(T1), 4(T2), 6(T3), 8(T4), 10(T5), 12(T6) and 24(T7).
description: Visual analogue scale (VAS), provided by patients, ranging from 0 to 10 (0= no pain and 10= worst possible pain). We considered a pain score between 1-3, 4-6 and 7-10 as mild, moderate and severe pain, respectively.
measure: Sedation-agitation Scores in the First 12 Postoperative Hours.
time frame: At postoperative hours 2(T1), 4(T2), 6(T3), 8(T4), 10(T5) and 12(T6).
description: Sedation-agitation scale (SAS), ranging from 1 to 7 (1=unarousable, 2=very sedated, 3=sedated, 4=calm and cooperative, 5=agitated, 6=very agitated and 7=dangerous agitation).
measure: Postoperative Nausea and Vomiting.
time frame: Postoperative nausea and vomiting during the first 12 postoperative hours.
description: Number of patients with postoperative nausea and vomiting in the first 12 postoperative hours.
arm group label: Dexmedetomidine
arm group type: Experimental
description: After anesthesia induction, patients who were randomized to the Dexmedetomidine group received a bolus of 1ug/kg in 10 minutes, followed by an infusion of 0.5ug/kg/h until the end of surgery. In the case of intraoperative increment of the blood pressure and/or heart rate more than 25% from its baseline, fentanyl 1ug/kg was administered.
arm group label: 0.9% Sodium-chloride
arm group type: Placebo Comparator
description: After anesthesia induction, patients who were randomized to the Placebo group received a bolus and infusion of 0.9% normal saline at the same rate as the Dexmedetomidine group until the end of surgery. In the case of intraoperative increment of the blood pressure and/or heart rate more than 25% from its baseline, fentanyl 1ug/kg was administered.
intervention type: Drug
intervention name: Dexmedetomidine
description: A bolus of 1ug/kg in 10 minutes, followed by an infusion of 0.5ug/kg/h until the end of surgery.
arm group label: Dexmedetomidine
other name: Precedex
intervention type: Drug
intervention name: 0.9% Sodium-chloride
description: The same infusion rate used in the dexmedetomidine group.
arm group label: 0.9% Sodium-chloride
other name: Normal saline
intervention type: Drug
intervention name: Fentanyl
description: Intraoperative fentanyl was given in case of 25% increment in the blood pressure and/or heart rate in comparison to baseline (previous anesthesia induction).
arm group label: 0.9% Sodium-chloride
arm group label: Dexmedetomidine
other name: Sublimaze
intervention type: Drug
intervention name: Morphine Sulfate
description: Boluses of 3mg of intravenous morphine were given in the postoperative acute care unit. Once the pain score was equal or less than 3/10 the patient-controlled analgesia pumps were installed and the patients were discharged to their room.
arm group label: 0.9% Sodium-chloride
arm group label: Dexmedetomidine
other name: Morphine
criteria: 
gender: All
minimum age: 18 Years
maximum age: 60 Years
healthy volunteers: No
last name: Mauricio Ibacache, MD, PhD
role: Study Director
affiliation: Pontificia Universidad Catolica de Chile
responsible party type: Principal Investigator
investigator affiliation: Pontificia Universidad Catolica de Chile
investigator full name: Eduardo Vega
investigator title: Instructor
mesh term: Insulin Resistance
mesh term: Glucose Intolerance
mesh term: Fentanyl
mesh term: Dexmedetomidine
mesh term: Morphine
sharing ipd: No
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 