<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/NCT01687894</url>
  </required_header>
  <id_info>
    <org_study_id>CNUH-2012-074</org_study_id>
    <nct_id>NCT01687894</nct_id>
  </id_info>
  <brief_title>Vasopressin to Prevent Hypotension During Beach Chair Surgery</brief_title>
  <official_title>Clinical Trials of Vasopressin for Prevention of Hypotension During Shoulder Surgery in Beach Chair Position Under General Anesthesia</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Chonnam National University Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Chonnam National University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Chonnam National University Hospital</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Patients undergoing surgery in beach chair position (BCP) are at risk for cerebral ischaemia.&#xD;
      The impacts of arginine vasopressin (AVP) on haemodynamics and cerebral oxygenation are&#xD;
      evaluated during surgery in BCP.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Patients undergoing shoulder surgery in BCP under general anaesthesia are randomly allocated&#xD;
      to receive i.v. normal saline (control group) or AVP 0.05 or 0.07 U kg-1 (AVP group, n = 15&#xD;
      each) 2 min before moving into BCP. Mean arterial pressure (MAP), heart rate (HR), jugular&#xD;
      venous bulb oxygen saturation (SjvO2) and regional cerebral tissue oxygen saturation (SctO2)&#xD;
      are measured before (pre-sitting in supine position) and after patients assumed BCP.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>May 2012</start_date>
  <completion_date type="Actual">December 2014</completion_date>
  <primary_completion_date type="Actual">April 2014</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>The magnitude of decrease of mean arterial pressure</measure>
    <time_frame>Baseline (before positioning) and lowest value within 10 min into beach chair position</time_frame>
    <description>Continuously measure mean arterial blood pressure before and after position change. Calculate the magnitude of maximum decrease of mean arterial pressure from baseline</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Jugular venous oxygen desaturation</measure>
    <time_frame>Up to 30 min after the positioning</time_frame>
    <description>Jugular venous oxygen saturation is continuously measured whether its saturation is decreased below 50% or/and 40% for longer than 5 min.</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Cerebral oxygen desaturation</measure>
    <time_frame>Up to 30 min after the position change</time_frame>
    <description>Continuously observe near-infrared spectroscopy measured cerebral oxygenation before and after beach chair position whether oxygen saturation decrease more than 20% from pre-sitting values</description>
  </other_outcome>
  <number_of_groups>4</number_of_groups>
  <enrollment type="Actual">74</enrollment>
  <condition>Rotator Cuff Tear Arthropathy</condition>
  <arm_group>
    <arm_group_label>Vasopressins &amp; propofol</arm_group_label>
    <description>Administer vasopressin 0.05 or 0.07 IU/kg before sitting position during propofol anesthesia.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo &amp; propofol</arm_group_label>
    <description>Administer saline 10 ml (placebo) 2 min before beach chair position during propofol anesthesia</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Vasopressins &amp; sevoflurane</arm_group_label>
    <description>Administer vasopressin 0.05 or 0.07 IU/kg 2 min before beach chair position during sevoflurane anesthesia</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo &amp; sevoflurane</arm_group_label>
    <description>Placebo (saline 10 ml) for vasopressin is administered 2 min before beach chair position during sevoflurane anesthesia</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Vasopressins</intervention_name>
    <description>Vasopressins propofol vasopressins sevoflurane</description>
    <arm_group_label>Vasopressins &amp; propofol</arm_group_label>
    <arm_group_label>Vasopressins &amp; sevoflurane</arm_group_label>
    <other_name>Arginine vasopressin</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <description>Placebo propofol &amp; placebo sevoflurane</description>
    <arm_group_label>Placebo &amp; propofol</arm_group_label>
    <arm_group_label>Placebo &amp; sevoflurane</arm_group_label>
    <other_name>saline 10 ml as placebo</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>propofol</intervention_name>
    <description>vasopressin propofol &amp; placebo propofol</description>
    <arm_group_label>Placebo &amp; propofol</arm_group_label>
    <arm_group_label>Vasopressins &amp; propofol</arm_group_label>
    <other_name>Intravenous anesthetic</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>sevoflurane</intervention_name>
    <description>vasopressins sevoflurane placebo sevoflurane</description>
    <arm_group_label>Placebo &amp; sevoflurane</arm_group_label>
    <arm_group_label>Vasopressins &amp; sevoflurane</arm_group_label>
    <other_name>general anesthetic</other_name>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Patients undergoing shoulder surgery in the beach chair position under the general&#xD;
        anesthesia&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria: elective arthroscopic shoulder surgery under general anesthesia in&#xD;
        beach chair position&#xD;
&#xD;
        Exclusion Criteria: preexisting cerebrovascular diseases, history of orthostatic&#xD;
        hypotension, age less than 18 yr, and the American Society of Anesthesiologists physical&#xD;
        status IV or V&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>70 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Kyung Y Yoo, M.D.,Ph.D</last_name>
    <role>Principal Investigator</role>
    <affiliation>Department of Anesthesiology and Pain Medicine, Chonnam National University Hospital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Department of Anesthesiology and Pain Medicine</name>
      <address>
        <city>Gwangju</city>
        <zip>501-757</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Korea, Republic of</country>
  </location_countries>
  <verification_date>September 2012</verification_date>
  <study_first_submitted>September 8, 2012</study_first_submitted>
  <study_first_submitted_qc>September 15, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 19, 2012</study_first_posted>
  <last_update_submitted>February 23, 2017</last_update_submitted>
  <last_update_submitted_qc>February 23, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">February 27, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Chonnam National University Hospital</investigator_affiliation>
    <investigator_full_name>Kyung Yeon Yoo</investigator_full_name>
    <investigator_title>Professor</investigator_title>
  </responsible_party>
  <keyword>cerebral oxygen saturation</keyword>
  <keyword>beach chair position</keyword>
  <keyword>hemodynamic</keyword>
  <keyword>jugular venous oximetry</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Rotator Cuff Tear Arthropathy</mesh_term>
    <mesh_term>Hypotension</mesh_term>
    <mesh_term>Rotator Cuff Injuries</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Vasopressins</mesh_term>
    <mesh_term>Arginine Vasopressin</mesh_term>
    <mesh_term>Propofol</mesh_term>
    <mesh_term>Anesthetics, Intravenous</mesh_term>
    <mesh_term>Anesthetics</mesh_term>
    <mesh_term>Sevoflurane</mesh_term>
    <mesh_term>Anesthetics, General</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/NCT01687894
org study id: CNUH-2012-074
nct id: NCT01687894
lead sponsor: 
collaborator: 
has dmc: No
Patients undergoing surgery in beach chair position (BCP) are at risk for cerebral ischaemia.
      The impacts of arginine vasopressin (AVP) on haemodynamics and cerebral oxygenation are
      evaluated during surgery in BCP.
Patients undergoing shoulder surgery in BCP under general anaesthesia are randomly allocated
      to receive i.v. normal saline (control group) or AVP 0.05 or 0.07 U kg-1 (AVP group, n = 15
      each) 2 min before moving into BCP. Mean arterial pressure (MAP), heart rate (HR), jugular
      venous bulb oxygen saturation (SjvO2) and regional cerebral tissue oxygen saturation (SctO2)
      are measured before (pre-sitting in supine position) and after patients assumed BCP.
observational model: Cohort
time perspective: Prospective
measure: The magnitude of decrease of mean arterial pressure
time frame: Baseline (before positioning) and lowest value within 10 min into beach chair position
description: Continuously measure mean arterial blood pressure before and after position change. Calculate the magnitude of maximum decrease of mean arterial pressure from baseline
measure: Jugular venous oxygen desaturation
time frame: Up to 30 min after the positioning
description: Jugular venous oxygen saturation is continuously measured whether its saturation is decreased below 50% or/and 40% for longer than 5 min.
measure: Cerebral oxygen desaturation
time frame: Up to 30 min after the position change
description: Continuously observe near-infrared spectroscopy measured cerebral oxygenation before and after beach chair position whether oxygen saturation decrease more than 20% from pre-sitting values
arm group label: Vasopressins & propofol
description: Administer vasopressin 0.05 or 0.07 IU/kg before sitting position during propofol anesthesia.
arm group label: Placebo & propofol
description: Administer saline 10 ml (placebo) 2 min before beach chair position during propofol anesthesia
arm group label: Vasopressins & sevoflurane
description: Administer vasopressin 0.05 or 0.07 IU/kg 2 min before beach chair position during sevoflurane anesthesia
arm group label: Placebo & sevoflurane
description: Placebo (saline 10 ml) for vasopressin is administered 2 min before beach chair position during sevoflurane anesthesia
intervention type: Drug
intervention name: Vasopressins
description: Vasopressins propofol vasopressins sevoflurane
arm group label: Vasopressins & propofol
arm group label: Vasopressins & sevoflurane
other name: Arginine vasopressin
intervention type: Drug
intervention name: Placebo
description: Placebo propofol & placebo sevoflurane
arm group label: Placebo & propofol
arm group label: Placebo & sevoflurane
other name: saline 10 ml as placebo
intervention type: Drug
intervention name: propofol
description: vasopressin propofol & placebo propofol
arm group label: Placebo & propofol
arm group label: Vasopressins & propofol
other name: Intravenous anesthetic
intervention type: Drug
intervention name: sevoflurane
description: vasopressins sevoflurane placebo sevoflurane
arm group label: Placebo & sevoflurane
arm group label: Vasopressins & sevoflurane
other name: general anesthetic
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 70 Years
healthy volunteers: No
last name: Kyung Y Yoo, M.D.,Ph.D
role: Principal Investigator
affiliation: Department of Anesthesiology and Pain Medicine, Chonnam National University Hospital
facility: 
country: Korea, Republic of
responsible party type: Principal Investigator
investigator affiliation: Chonnam National University Hospital
investigator full name: Kyung Yeon Yoo
investigator title: Professor
mesh term: Rotator Cuff Tear Arthropathy
mesh term: Hypotension
mesh term: Rotator Cuff Injuries
mesh term: Vasopressins
mesh term: Arginine Vasopressin
mesh term: Propofol
mesh term: Anesthetics, Intravenous
mesh term: Anesthetics
mesh term: Sevoflurane
mesh term: Anesthetics, General