<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/NCT02244177</url>
  </required_header>
  <id_info>
    <org_study_id>VGHKS-103-080</org_study_id>
    <nct_id>NCT02244177</nct_id>
  </id_info>
  <brief_title>Relationship of Essential Hypertension and Its Treatments on the Postoperative Pain Management: a Prospective, Observational, Cross-sectional Study</brief_title>
  <sponsors>
    <lead_sponsor>
      <agency>Kaohsiung Veterans General Hospital.</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Kaohsiung Veterans General Hospital.</source>
  <brief_summary>
    <textblock>
      Numbers of postoperative PCA related side effects among three groups will be determined by&#xD;
      comparing and analyzing frequency distributions. To determine whether the patients with&#xD;
      hypertension require less post operative opiate analgesics than others, multivariate analysis&#xD;
      with repeated measures will be performed to identify the major and the minor factors&#xD;
      predicting the use of postoperative pain therapy. The major aim of the study is to test the&#xD;
      hypothesis that the morphine comsumpted by the hypertension group is less than those of the&#xD;
      normotension group. The minor aims for the study are the difference related to pain&#xD;
      intensity, or the incidence of side effects among groups.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date>November 2013</start_date>
  <primary_completion_date type="Anticipated">December 2015</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Pain</measure>
    <time_frame>Post-operation Day1 to Day4</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Morphine consumption</measure>
    <time_frame>Post-operation Day1 to Day4</time_frame>
  </secondary_outcome>
  <other_outcome>
    <measure>side effects</measure>
    <time_frame>Post-operation Day1 to Day4</time_frame>
  </other_outcome>
  <number_of_groups>3</number_of_groups>
  <enrollment type="Anticipated">300</enrollment>
  <condition>Hypertension</condition>
  <arm_group>
    <arm_group_label>normotension group</arm_group_label>
    <description>Until 11,March, 2015, 31 cases are collected.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>hypertension group without treatment</arm_group_label>
    <description>Until 11,March, 2015, 60 cases are collected.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>hypertension group with antihypertensive treatment</arm_group_label>
    <description>(ACEI, beta-blocker, Ca blocker, Diuretics) prior to the surgery.&#xD;
Until 11,March, 2015, 59 cases are collected.</description>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        Those patients enrolled will be divided into three groups as follows As the treatment and&#xD;
        choice of drugs for hypertension is complex but internation guideline-oriented. We would&#xD;
        like to enroll enough sample size in the hypertensive groups and subgroups.&#xD;
&#xD;
          1. Normaltension group (control group)&#xD;
&#xD;
          2. Hypertension without treatment&#xD;
&#xD;
          3. Hypertension with treatment as follows (according to subject's daily routine Tx, the&#xD;
             PI not involved into the choice and further manitence of drugs) I. Hypertension with&#xD;
             treatment with ACEI II. Hypertension with treatment with β blocker III. Hypertension&#xD;
             with treatment with Ca channel blocker IV. Hypertension with treatment with diuretics&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  300 eligible subjects&#xD;
&#xD;
          -  No contraindication for inhalation anesthesia&#xD;
&#xD;
          -  Elective surgery&#xD;
&#xD;
          -  Age between 20-75 y/o&#xD;
&#xD;
          -  No contraindication for postoperative morphine pain control&#xD;
&#xD;
          -  Female or male&#xD;
&#xD;
          -  Essential hypertension stage I and II (140&lt;=SBP&lt;=180; 90&lt;=DBP&lt;=110)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Liver disease&#xD;
&#xD;
          -  Renal disease&#xD;
&#xD;
          -  Those who is presumed to go to ICU after surgery&#xD;
&#xD;
          -  The patients with dementia or conscious disturbance&#xD;
&#xD;
          -  Pregnancy or breast feeding&#xD;
&#xD;
          -  Secondary hypertension&#xD;
&#xD;
          -  events in recent 6 months myocardial infarction cardiac bypass surgery unstable angina&#xD;
             cerebrovascular events congestive heart failure significant arrhythmia thoracic&#xD;
             surgery&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>75 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Yuan Yi Chia, Bachelor</last_name>
    <phone>88673468183</phone>
    <email>yychia@isca.vghks.gov.tw</email>
  </overall_contact>
  <location>
    <facility>
      <name>Kaohsiung Veterans General Hospital</name>
      <address>
        <city>Kaohsiung</city>
        <zip>81362</zip>
        <country>Taiwan</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Yuan Yi Chia, Bachelor</last_name>
      <phone>88673468183</phone>
      <email>yychia@isca.vghks.gov.tw</email>
    </contact>
  </location>
  <location_countries>
    <country>Taiwan</country>
  </location_countries>
  <verification_date>March 2015</verification_date>
  <study_first_submitted>September 10, 2014</study_first_submitted>
  <study_first_submitted_qc>September 16, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 18, 2014</study_first_posted>
  <last_update_submitted>March 30, 2015</last_update_submitted>
  <last_update_submitted_qc>March 30, 2015</last_update_submitted_qc>
  <last_update_posted type="Estimate">April 1, 2015</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Kaohsiung Veterans General Hospital.</investigator_affiliation>
    <investigator_full_name>Yuan-Yi Chia</investigator_full_name>
    <investigator_title>anesthesia doctor</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Hypertension</mesh_term>
  </condition_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/NCT02244177
org study id: VGHKS-103-080
nct id: NCT02244177
lead sponsor: 
Numbers of postoperative PCA related side effects among three groups will be determined by
      comparing and analyzing frequency distributions. To determine whether the patients with
      hypertension require less post operative opiate analgesics than others, multivariate analysis
      with repeated measures will be performed to identify the major and the minor factors
      predicting the use of postoperative pain therapy. The major aim of the study is to test the
      hypothesis that the morphine comsumpted by the hypertension group is less than those of the
      normotension group. The minor aims for the study are the difference related to pain
      intensity, or the incidence of side effects among groups.
observational model: Cohort
time perspective: Prospective
measure: Pain
time frame: Post-operation Day1 to Day4
measure: Morphine consumption
time frame: Post-operation Day1 to Day4
measure: side effects
time frame: Post-operation Day1 to Day4
arm group label: normotension group
description: Until 11,March, 2015, 31 cases are collected.
arm group label: hypertension group without treatment
description: Until 11,March, 2015, 60 cases are collected.
arm group label: hypertension group with antihypertensive treatment
description: (ACEI, beta-blocker, Ca blocker, Diuretics) prior to the surgery.
Until 11,March, 2015, 59 cases are collected.
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 20 Years
maximum age: 75 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Yuan Yi Chia, Bachelor
phone: 88673468183
email: yychia@isca.vghks.gov.tw
facility: 
status: Recruiting
contact: 
country: Taiwan
responsible party type: Principal Investigator
investigator affiliation: Kaohsiung Veterans General Hospital.
investigator full name: Yuan-Yi Chia
investigator title: anesthesia doctor
mesh term: Hypertension