<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/NCT02245581</url>
  </required_header>
  <id_info>
    <org_study_id>VGHKS-102-036</org_study_id>
    <nct_id>NCT02245581</nct_id>
  </id_info>
  <brief_title>Evaluations of Optimizing Perioperative Fluid Management on Postoperative Pain Outcomes</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>
      Patient characteristics, duration of surgery, and infusion volumes will be compared between&#xD;
      the groups. Oxygen transport and organ function will be compared Length of hospital stay,&#xD;
      morbidity, postoperative pain intensity were compared. Continuous variables will be analyzed&#xD;
      using the student t-test and discrete variables will be analyzed using Chi-Square test.&#xD;
      P-value &lt;0.05 will be considered significant, where appropriate 95% confidence intervals will&#xD;
      be calculated. Statistical analysis will be carried out using standardize statistical&#xD;
      programs SPSS 12.0 for windows.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>April 2013</start_date>
  <primary_completion_date type="Actual">April 2014</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Pain at rest and movement</measure>
    <time_frame>Post-operation Day1 to Day4</time_frame>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">72</enrollment>
  <condition>Patients Major Laminectomy Surgery</condition>
  <arm_group>
    <arm_group_label>SVV-guided fluid management</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>SVV : Stoke volume variation</description>
  </arm_group>
  <arm_group>
    <arm_group_label>CVP-guided fluid management</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>CVP : Central venous pressure</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>SVV-guided fluid management</intervention_name>
    <arm_group_label>SVV-guided fluid management</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>CVP-guided fluid management</intervention_name>
    <arm_group_label>CVP-guided fluid management</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  All patients are undergoing elective spine laminectomy&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  age &lt;20 yr&#xD;
&#xD;
          -  emergency surgery&#xD;
&#xD;
          -  coagulopathy&#xD;
&#xD;
          -  renal and hepatic dysfunction&#xD;
&#xD;
          -  hyperthyroidism, and cardiac rhythm other than sinus rhythm&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Kaohsiung Veterans General Hospital</name>
      <address>
        <city>Kaohsiung</city>
        <zip>81362</zip>
        <country>Taiwan</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Taiwan</country>
  </location_countries>
  <verification_date>September 2014</verification_date>
  <study_first_submitted>September 10, 2014</study_first_submitted>
  <study_first_submitted_qc>September 18, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 19, 2014</study_first_posted>
  <last_update_submitted>September 18, 2014</last_update_submitted>
  <last_update_submitted_qc>September 18, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">September 19, 2014</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>
  <!-- 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/NCT02245581
org study id: VGHKS-102-036
nct id: NCT02245581
lead sponsor: 
Patient characteristics, duration of surgery, and infusion volumes will be compared between
      the groups. Oxygen transport and organ function will be compared Length of hospital stay,
      morbidity, postoperative pain intensity were compared. Continuous variables will be analyzed
      using the student t-test and discrete variables will be analyzed using Chi-Square test.
      P-value <0.05 will be considered significant, where appropriate 95% confidence intervals will
      be calculated. Statistical analysis will be carried out using standardize statistical
      programs SPSS 12.0 for windows.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Pain at rest and movement
time frame: Post-operation Day1 to Day4
arm group label: SVV-guided fluid management
arm group type: Active Comparator
description: SVV : Stoke volume variation
arm group label: CVP-guided fluid management
arm group type: Active Comparator
description: CVP : Central venous pressure
intervention type: Procedure
intervention name: SVV-guided fluid management
arm group label: SVV-guided fluid management
intervention type: Procedure
intervention name: CVP-guided fluid management
arm group label: CVP-guided fluid management
criteria: 
gender: All
minimum age: 20 Years
maximum age: N/A
healthy volunteers: No
facility: 
country: Taiwan
responsible party type: Principal Investigator
investigator affiliation: Kaohsiung Veterans General Hospital.
investigator full name: Yuan-Yi Chia
investigator title: anesthesia doctor