<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/NCT02201121</url>
  </required_header>
  <id_info>
    <org_study_id>plaghran001</org_study_id>
    <nct_id>NCT02201121</nct_id>
  </id_info>
  <brief_title>Influences of Phenylephrine, Dopamine and Ephedrine on Stroke Volume Variation and Pulse Pressure Variation</brief_title>
  <official_title>Influences of Phenylephrine, Dopamine and Ephedrine on Stroke Volume Variation and Pulse Pressure Variation</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Chinese PLA General Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Chinese PLA General Hospital</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Although induced hypertension decreased SVV and PPV,the influences of stroke volume variation&#xD;
      and pulse pressure variation caused by phenylephrine,dopamine and ephedrine were unknown.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Pulse pressure variation (PPV) and stroke volume variation (SVV) during mechanical&#xD;
      ventilation have been shown to be effective parameters to predict preload responsiveness.&#xD;
      Although induced hypertension decreases PPV and SVV, the influences of phenylephrine,&#xD;
      dopamine and ephedrine on PPV and SVV are unknown.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>March 2014</start_date>
  <completion_date type="Actual">June 2014</completion_date>
  <primary_completion_date type="Actual">June 2014</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <masking>Single (Participant)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>invasive arterial blood pressure as a Measure of Safety</measure>
    <time_frame>DAY 1</time_frame>
    <description>if instability of circulation, stop the clinical trial</description>
  </primary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">94</enrollment>
  <condition>Circulation</condition>
  <condition>Drug Dose</condition>
  <condition>Calculated SAP</condition>
  <arm_group>
    <arm_group_label>phenylephrine group, dopamine group, ephedrine group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>phenylephrine group: use the phenylephrine to increase the SAP from low to high level.&#xD;
dopamine group: use the dopamine to increase the SAP from low to high level. ephedrine group:use the ephedrine to increase the SAP from low to high level.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Influences of phenylephrine, dopamine and ephedrine on stroke volume variation and pulse pressure variation</intervention_name>
    <description>This research mainly study the effect of clinical commonly used vasoconstrictor drugs on blood pressure of pressure</description>
    <arm_group_label>phenylephrine group, dopamine group, ephedrine group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Their American Society of Anesthesiologists (ASA) physical status was 1 or 2&#xD;
&#xD;
          -  Body mass index (BMI) ranged from 18 to 26&#xD;
&#xD;
          -  None of the patients had known diabetes mellitus, hypertension, cardiovascular,&#xD;
             pulmonary, endocrinological, neurological diseases, or diseases that influenced&#xD;
             intravascular fluid volume or balance&#xD;
&#xD;
          -  All patients had a preoperative fast for at least 8 h and routine atropine&#xD;
             intramuscular injection&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Persistent arrhythmias&#xD;
&#xD;
          -  Intraoperative application of vasoactive drugs except phenylephrine, dopamine and&#xD;
             ephedrine&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>60 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <verification_date>October 2013</verification_date>
  <study_first_submitted>July 22, 2014</study_first_submitted>
  <study_first_submitted_qc>July 24, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 25, 2014</study_first_posted>
  <last_update_submitted>July 24, 2014</last_update_submitted>
  <last_update_submitted_qc>July 24, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">July 25, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Chinese PLA General Hospital</investigator_affiliation>
    <investigator_full_name>Ran Kong</investigator_full_name>
    <investigator_title>Department of Anesthesiology, People's Liberation Army General Hospital, Beijing, China</investigator_title>
  </responsible_party>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Phenylephrine</mesh_term>
    <mesh_term>Dopamine</mesh_term>
    <mesh_term>Oxymetazoline</mesh_term>
    <mesh_term>Ephedrine</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/NCT02201121
org study id: plaghran001
nct id: NCT02201121
lead sponsor: 
has dmc: Yes
Although induced hypertension decreased SVV and PPV,the influences of stroke volume variation
      and pulse pressure variation caused by phenylephrine,dopamine and ephedrine were unknown.
Pulse pressure variation (PPV) and stroke volume variation (SVV) during mechanical
      ventilation have been shown to be effective parameters to predict preload responsiveness.
      Although induced hypertension decreases PPV and SVV, the influences of phenylephrine,
      dopamine and ephedrine on PPV and SVV are unknown.
allocation: N/A
intervention model: Single Group Assignment
masking: Single (Participant)
measure: invasive arterial blood pressure as a Measure of Safety
time frame: DAY 1
description: if instability of circulation, stop the clinical trial
arm group label: phenylephrine group, dopamine group, ephedrine group
arm group type: Experimental
description: phenylephrine group: use the phenylephrine to increase the SAP from low to high level.
dopamine group: use the dopamine to increase the SAP from low to high level. ephedrine group:use the ephedrine to increase the SAP from low to high level.
intervention type: Other
intervention name: Influences of phenylephrine, dopamine and ephedrine on stroke volume variation and pulse pressure variation
description: This research mainly study the effect of clinical commonly used vasoconstrictor drugs on blood pressure of pressure
arm group label: phenylephrine group, dopamine group, ephedrine group
criteria: 
gender: All
minimum age: 18 Years
maximum age: 60 Years
healthy volunteers: No
responsible party type: Principal Investigator
investigator affiliation: Chinese PLA General Hospital
investigator full name: Ran Kong
investigator title: Department of Anesthesiology, People's Liberation Army General Hospital, Beijing, China
mesh term: Phenylephrine
mesh term: Dopamine
mesh term: Oxymetazoline
mesh term: Ephedrine