<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/NCT04454515</url>
  </required_header>
  <id_info>
    <org_study_id>202004120MINB</org_study_id>
    <nct_id>NCT04454515</nct_id>
  </id_info>
  <brief_title>The Effect of Intraoperative Dexmedetomidine on Postoperative Morphine Requirements After Breast Cancer Surgery</brief_title>
  <official_title>The Effect of Intraoperative Dexmedetomidine on Postoperative Morphine Requirements and Oral Intake After Breast Cancer Surgery</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>National Taiwan University Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>National Taiwan University Hospital</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <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>
      Dexmedetomidine is an α2 receptor agonist with sedative and analgesic properties. In previous&#xD;
      reports, dexmedetomidine improves smoothness of postoperative recovery and reduces&#xD;
      intraoperatory imflammatory responses. As patients receiving breast surgeries are especially&#xD;
      vulnerable to postoperative nausea/ vomiting, the dosage of narcotics and associated&#xD;
      complications were concerned for not only comfortness but also postoperative oral intake and&#xD;
      discharge. The invetigators aimed to compare the effects of dexmedetomidine infusion versus&#xD;
      placebo on postoperative narcotics requirement, complications, and oral intake.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Dexmedetomidine is an α2 receptor agonist with sedative and analgesic properties. In previous&#xD;
      reports, dexmedetomidine improves smoothness of postoperative recovery and reduces&#xD;
      intraoperatory imflammatory responses. As patients receiving breast surgeries are especially&#xD;
      vulnerable to postoperative nausea/ vomiting, the dosage of narcotics and associated&#xD;
      complications were concerned for not only comfortness but also postoperative oral intake and&#xD;
      discharge.&#xD;
&#xD;
      The invetigators aimed to compare the effects of dexmedetomidine infusion versus placebo on&#xD;
      postoperative narcotics requirement, complications, and oral intake.&#xD;
&#xD;
      The participantss under general anesthesia and aged from 30 to 65 years old will be enrolled.&#xD;
      All subjects were randomized into the dexmedetomidine or placebo group. They received placebo&#xD;
      (group P, n = 30) or dexmedetomidine (loading dose of 1 μg kg-1 followed by 0.5 μg kg-1 h-1)&#xD;
      (group D, n = 30) to the end of surgery.&#xD;
&#xD;
      Data collected included intraoperative and postoperative opioid consumption. Postoperative&#xD;
      questionare including PONV, Pain intensity, I-FEED questionnaire. Prospective analysis will&#xD;
      be performed on the prospectively collected data.&#xD;
&#xD;
      We expected to examine if intraoperative dexmedetomidine decreases the postoperative opioid&#xD;
      consumption and associated complications, and enhances the gastrointestinal recovery and oral&#xD;
      intake with narcotic-sparing effect.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">April 20, 2021</start_date>
  <completion_date type="Anticipated">July 1, 2025</completion_date>
  <primary_completion_date type="Anticipated">July 1, 2024</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>
    <intervention_model_description>one group is going to receive precedex and another is placebo.</intervention_model_description>
    <primary_purpose>Prevention</primary_purpose>
    <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
    <masking_description>double blind randomized study</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>morphine consumption</measure>
    <time_frame>postoperative 7 days</time_frame>
    <description>postoperative morphine consumption by mg</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>i-feed score</measure>
    <time_frame>POD2, POD7</time_frame>
    <description>recovery of eating by I-feed questionare ( score: 0-14), minimum 0 (complete recovery without eating problems), maximum 14</description>
  </secondary_outcome>
  <other_outcome>
    <measure>changes of OCTT (orocecal transit time) by minutes</measure>
    <time_frame>preoperative and POD1</time_frame>
    <description>detect the hydrogen in exhaled gas every 15 minutes after drinking 10 gram lactulose. The time with hydrogen production more than 10 ppm is the OCTT. The changes of OCTT time between pre-operation and POD1</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">60</enrollment>
  <condition>Morphine Consumption</condition>
  <arm_group>
    <arm_group_label>dexmedetomidine</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>patient recieving dexmedetomidine</description>
  </arm_group>
  <arm_group>
    <arm_group_label>placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>patients receiving placebo</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Dexmedetomidine</intervention_name>
    <description>Dexmedetomidine is an α2 receptor agonist with sedative and analgesic properties. In previous reports, dexmedetomidine improves smoothness of postoperative recovery and reduces intraoperatory imflammatory responses. As patients receiving breast surgeries are especially vulnerable to postoperative nausea/ vomiting, the dosage of narcotics and associated complications were concerned for not only comfortness but also postoperative oral intake and discharge.</description>
    <arm_group_label>dexmedetomidine</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>placebo</intervention_name>
    <description>normal saline infusion</description>
    <arm_group_label>placebo</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients who fulfill the criteria of breast cancer under general anesthesia.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Major systemic disease, such as congestive heart failure, liver cirrhosis, end stage&#xD;
             renal disease and malignancy.&#xD;
&#xD;
          -  Patients who have the risk of difficult ventilation or intubation.&#xD;
&#xD;
          -  Pregnant women.&#xD;
&#xD;
          -  Coagulopathy.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Ya-Jung Cheng, MD,PhD</last_name>
    <phone>23220322</phone>
    <email>chengyj@ntu.edu.tw</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Chih-Jun Lai, MD</last_name>
    <phone>23123456</phone>
    <phone_ext>62158</phone_ext>
    <email>littlecherrytw@gmail.com</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>National Taiwan University Cancer Center</name>
      <address>
        <city>Taipei</city>
        <zip>106</zip>
        <country>Taiwan</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Yajung cheng</last_name>
    </contact>
  </location>
  <location_countries>
    <country>Taiwan</country>
  </location_countries>
  <verification_date>April 2022</verification_date>
  <study_first_submitted>June 29, 2020</study_first_submitted>
  <study_first_submitted_qc>June 30, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 1, 2020</study_first_posted>
  <last_update_submitted>May 3, 2022</last_update_submitted>
  <last_update_submitted_qc>May 3, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">May 9, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Dexmedetomidine</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
    <ipd_description>due to the ethical concern, we did not share our paatients' data.</ipd_description>
  </patient_data>
  <!-- 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/NCT04454515
org study id: 202004120MINB
nct id: NCT04454515
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
is us export: No
Dexmedetomidine is an α2 receptor agonist with sedative and analgesic properties. In previous
      reports, dexmedetomidine improves smoothness of postoperative recovery and reduces
      intraoperatory imflammatory responses. As patients receiving breast surgeries are especially
      vulnerable to postoperative nausea/ vomiting, the dosage of narcotics and associated
      complications were concerned for not only comfortness but also postoperative oral intake and
      discharge. The invetigators aimed to compare the effects of dexmedetomidine infusion versus
      placebo on postoperative narcotics requirement, complications, and oral intake.
Dexmedetomidine is an α2 receptor agonist with sedative and analgesic properties. In previous
      reports, dexmedetomidine improves smoothness of postoperative recovery and reduces
      intraoperatory imflammatory responses. As patients receiving breast surgeries are especially
      vulnerable to postoperative nausea/ vomiting, the dosage of narcotics and associated
      complications were concerned for not only comfortness but also postoperative oral intake and
      discharge.

      The invetigators aimed to compare the effects of dexmedetomidine infusion versus placebo on
      postoperative narcotics requirement, complications, and oral intake.

      The participantss under general anesthesia and aged from 30 to 65 years old will be enrolled.
      All subjects were randomized into the dexmedetomidine or placebo group. They received placebo
      (group P, n = 30) or dexmedetomidine (loading dose of 1 μg kg-1 followed by 0.5 μg kg-1 h-1)
      (group D, n = 30) to the end of surgery.

      Data collected included intraoperative and postoperative opioid consumption. Postoperative
      questionare including PONV, Pain intensity, I-FEED questionnaire. Prospective analysis will
      be performed on the prospectively collected data.

      We expected to examine if intraoperative dexmedetomidine decreases the postoperative opioid
      consumption and associated complications, and enhances the gastrointestinal recovery and oral
      intake with narcotic-sparing effect.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: one group is going to receive precedex and another is placebo.
primary purpose: Prevention
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
masking description: double blind randomized study
measure: morphine consumption
time frame: postoperative 7 days
description: postoperative morphine consumption by mg
measure: i-feed score
time frame: POD2, POD7
description: recovery of eating by I-feed questionare ( score: 0-14), minimum 0 (complete recovery without eating problems), maximum 14
measure: changes of OCTT (orocecal transit time) by minutes
time frame: preoperative and POD1
description: detect the hydrogen in exhaled gas every 15 minutes after drinking 10 gram lactulose. The time with hydrogen production more than 10 ppm is the OCTT. The changes of OCTT time between pre-operation and POD1
arm group label: dexmedetomidine
arm group type: Experimental
description: patient recieving dexmedetomidine
arm group label: placebo
arm group type: Placebo Comparator
description: patients receiving placebo
intervention type: Drug
intervention name: Dexmedetomidine
description: Dexmedetomidine is an α2 receptor agonist with sedative and analgesic properties. In previous reports, dexmedetomidine improves smoothness of postoperative recovery and reduces intraoperatory imflammatory responses. As patients receiving breast surgeries are especially vulnerable to postoperative nausea/ vomiting, the dosage of narcotics and associated complications were concerned for not only comfortness but also postoperative oral intake and discharge.
arm group label: dexmedetomidine
intervention type: Drug
intervention name: placebo
description: normal saline infusion
arm group label: placebo
criteria: 
gender: All
minimum age: 20 Years
maximum age: 80 Years
healthy volunteers: No
last name: Ya-Jung Cheng, MD,PhD
phone: 23220322
email: chengyj@ntu.edu.tw
last name: Chih-Jun Lai, MD
phone: 23123456
phone ext: 62158
email: littlecherrytw@gmail.com
facility: 
status: Recruiting
contact: 
country: Taiwan
responsible party type: Sponsor
mesh term: Dexmedetomidine
sharing ipd: No
ipd description: due to the ethical concern, we did not share our paatients' data.