<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/NCT02220361</url>
  </required_header>
  <id_info>
    <org_study_id>JNi</org_study_id>
    <secondary_id>DAGZWCMC</secondary_id>
    <nct_id>NCT02220361</nct_id>
  </id_info>
  <brief_title>Dexmedetomidine on Prevention of Side Effects of Hemabate</brief_title>
  <official_title>Phase 4 Study of Effects of Dexmedetomidine on Prevention of Side Effects of Hemabate in Cesarean Section Patients</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Jin Ni</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Guangzhou Women and Children's Medical Center</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Hemabate is often used for gynecological patients. Hemabate is associated with many side&#xD;
      effects, including a burning sensation in the stomach, nausea, vomiting, diarrhea etc. It is&#xD;
      reported that dexmedetomidine reduce gastrointestinal reaction during perioperative period.&#xD;
      We design this clinical trial to find if dexmedetomidine can prevent the side effects of&#xD;
      hemabate in Cesarean Section patients.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Enrolling by invitation</last_known_status>
  <start_date>September 2014</start_date>
  <completion_date type="Anticipated">December 2014</completion_date>
  <primary_completion_date type="Anticipated">December 2014</primary_completion_date>
  <phase>Phase 4</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Prevention</primary_purpose>
    <masking>Triple (Participant, Care Provider, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>SpO2 Change</measure>
    <time_frame>participants will be followed for the duration of surgery, an expected average of 2 hours</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>systolic blood pressure and diastolic blood pressure change</measure>
    <time_frame>participants will be followed for the duration of surgery, an expected average of 2 hours</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Heart rate change</measure>
    <time_frame>participants will be followed for the duration of surgery, an expected average of 2 hours</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>nausea</measure>
    <time_frame>24 h postoperatively</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>vomiting</measure>
    <time_frame>24h postoperatively</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>fever</measure>
    <time_frame>24h postoperatively</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>diarrhea</measure>
    <time_frame>24h postoperatively</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>headache</measure>
    <time_frame>24h postoperatively</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>elevated blood pressure</measure>
    <time_frame>24h postoperatively</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>chest congestion</measure>
    <time_frame>24h postoperatively</time_frame>
  </primary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">120</enrollment>
  <condition>Gynecological Patient</condition>
  <arm_group>
    <arm_group_label>placebo group</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>received 20 ml intravenous physiological saline</description>
  </arm_group>
  <arm_group>
    <arm_group_label>low dose dexmedetomidine group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>received 0.5μgkg-1 intravenous dexmedetomidine (Jiang Su Heng Rui Medicine Co. Ltd, Jiangsu Province, China) diluted to 20ml with physiological saline</description>
  </arm_group>
  <arm_group>
    <arm_group_label>hemabate+high dose dexmedetomidine group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>received 1μgkg-1 intravenous dexmedetomidine (Jiang Su Heng Rui Medicine Co. Ltd, Jiangsu Province, China) diluted to 20ml with physiological saline</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>placebo</intervention_name>
    <description>received 20 ml intravenous physiological saline The infusion were completed in 30 minutes.</description>
    <arm_group_label>placebo group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>low dose dexmedetomidine</intervention_name>
    <description>received 0.5μgkg-1 intravenous dexmedetomidine (Jiang Su Heng Rui Medicine Co. Ltd, Jiangsu Province, China) diluted to 20ml with physiological saline The infusion were completed in 30 minutes.</description>
    <arm_group_label>low dose dexmedetomidine group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>high dose dexmedetomidine</intervention_name>
    <description>received 1μgkg-1 intravenous dexmedetomidine (Jiang Su Heng Rui Medicine Co. Ltd, Jiangsu Province, China) diluted to 20ml with physiological saline.&#xD;
The infusion was completed in 30 minutes</description>
    <arm_group_label>hemabate+high dose dexmedetomidine group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        gynecological patients&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Neuromuscular and endocrine diseases&#xD;
&#xD;
          -  Allergic reactions to a2-adrenergic agonist&#xD;
&#xD;
          -  Previous abdominal surgery including prior caesarean section.&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>40 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <verification_date>September 2014</verification_date>
  <study_first_submitted>August 14, 2014</study_first_submitted>
  <study_first_submitted_qc>August 18, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 19, 2014</study_first_posted>
  <last_update_submitted>September 28, 2014</last_update_submitted>
  <last_update_submitted_qc>September 28, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">September 30, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>Guangzhou Women and Children's Medical Center</investigator_affiliation>
    <investigator_full_name>Jin Ni</investigator_full_name>
    <investigator_title>Department of Anesthesiology</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/NCT02220361
org study id: JNi
secondary id: DAGZWCMC
nct id: NCT02220361
lead sponsor: 
has dmc: Yes
Hemabate is often used for gynecological patients. Hemabate is associated with many side
      effects, including a burning sensation in the stomach, nausea, vomiting, diarrhea etc. It is
      reported that dexmedetomidine reduce gastrointestinal reaction during perioperative period.
      We design this clinical trial to find if dexmedetomidine can prevent the side effects of
      hemabate in Cesarean Section patients.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: Triple (Participant, Care Provider, Outcomes Assessor)
measure: SpO2 Change
time frame: participants will be followed for the duration of surgery, an expected average of 2 hours
measure: systolic blood pressure and diastolic blood pressure change
time frame: participants will be followed for the duration of surgery, an expected average of 2 hours
measure: Heart rate change
time frame: participants will be followed for the duration of surgery, an expected average of 2 hours
measure: nausea
time frame: 24 h postoperatively
measure: vomiting
time frame: 24h postoperatively
measure: fever
time frame: 24h postoperatively
measure: diarrhea
time frame: 24h postoperatively
measure: headache
time frame: 24h postoperatively
measure: elevated blood pressure
time frame: 24h postoperatively
measure: chest congestion
time frame: 24h postoperatively
arm group label: placebo group
arm group type: Placebo Comparator
description: received 20 ml intravenous physiological saline
arm group label: low dose dexmedetomidine group
arm group type: Experimental
description: received 0.5μgkg-1 intravenous dexmedetomidine (Jiang Su Heng Rui Medicine Co. Ltd, Jiangsu Province, China) diluted to 20ml with physiological saline
arm group label: hemabate+high dose dexmedetomidine group
arm group type: Experimental
description: received 1μgkg-1 intravenous dexmedetomidine (Jiang Su Heng Rui Medicine Co. Ltd, Jiangsu Province, China) diluted to 20ml with physiological saline
intervention type: Drug
intervention name: placebo
description: received 20 ml intravenous physiological saline The infusion were completed in 30 minutes.
arm group label: placebo group
intervention type: Drug
intervention name: low dose dexmedetomidine
description: received 0.5μgkg-1 intravenous dexmedetomidine (Jiang Su Heng Rui Medicine Co. Ltd, Jiangsu Province, China) diluted to 20ml with physiological saline The infusion were completed in 30 minutes.
arm group label: low dose dexmedetomidine group
intervention type: Drug
intervention name: high dose dexmedetomidine
description: received 1μgkg-1 intravenous dexmedetomidine (Jiang Su Heng Rui Medicine Co. Ltd, Jiangsu Province, China) diluted to 20ml with physiological saline.
The infusion was completed in 30 minutes
arm group label: hemabate+high dose dexmedetomidine group
criteria: 
gender: Female
minimum age: 18 Years
maximum age: 40 Years
healthy volunteers: Accepts Healthy Volunteers
responsible party type: Sponsor-Investigator
investigator affiliation: Guangzhou Women and Children's Medical Center
investigator full name: Jin Ni
investigator title: Department of Anesthesiology
mesh term: Dexmedetomidine