<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/NCT02186990</url>
  </required_header>
  <id_info>
    <org_study_id>Odu-2</org_study_id>
    <nct_id>NCT02186990</nct_id>
  </id_info>
  <brief_title>Comparison of Etomidate, Propofol and Etomidate-propofol Combination in Terms of Effects on Haemodynamic Response to Intubation</brief_title>
  <sponsors>
    <lead_sponsor>
      <agency>T.C. ORDU ÜNİVERSİTESİ</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>T.C. ORDU ÜNİVERSİTESİ</source>
  <brief_summary>
    <textblock>
      The purpose of this study is to evaluate the effect of propofol, etomidate and&#xD;
      propofol-etomidate combination on hemodynamic responses during laryngoscopy and tracheal&#xD;
      intubation and assess the adverse effect related to this drugs.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>May 2014</start_date>
  <primary_completion_date type="Actual">August 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>Single (Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>haemodynamic values</measure>
    <time_frame>in ten minutes after intubation</time_frame>
    <description>e.g., heart rate, blood pressure (mean arterial pressure)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>adverse effect of study drugs</measure>
    <time_frame>within in 30 minutes drug administration</time_frame>
    <description>e.g. myoclonus, injection pain, allergy, skin rash</description>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">90</enrollment>
  <condition>Induction of Anaesthesia</condition>
  <arm_group>
    <arm_group_label>propofol</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>etomidate</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>propofol-etomidate</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>propofol</intervention_name>
    <description>2,5 mg/kg</description>
    <arm_group_label>propofol-etomidate</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>etomidate</intervention_name>
    <description>0,3 mg/kg</description>
    <arm_group_label>etomidate</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>etomidate-propofol</intervention_name>
    <description>0,15 mg/kg etomidate + 1,25 mg/kg propofol</description>
    <arm_group_label>propofol</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  between 18 - 65 age&#xD;
&#xD;
          -  ASA I - II status&#xD;
&#xD;
          -  elective surgery&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  emergency surgery&#xD;
&#xD;
          -  pregnancy&#xD;
&#xD;
          -  alcohol and drug abuse&#xD;
&#xD;
          -  HT and cardiovascular disease&#xD;
&#xD;
          -  BMI &gt; 25 kg/m2&#xD;
&#xD;
          -  hypersensitivity against study drug&#xD;
&#xD;
          -  sedative drug use in last month&#xD;
&#xD;
          -  difficult intubation&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Anesthesiology and Reanimation Dept. Ordu University Training and Research Hospital</name>
      <address>
        <city>Altınordu</city>
        <state>Ordu</state>
        <zip>52100</zip>
        <country>Turkey</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Turkey</country>
  </location_countries>
  <verification_date>August 2014</verification_date>
  <study_first_submitted>June 6, 2014</study_first_submitted>
  <study_first_submitted_qc>July 7, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 10, 2014</study_first_posted>
  <last_update_submitted>August 12, 2014</last_update_submitted>
  <last_update_submitted_qc>August 12, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">August 13, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>T.C. ORDU ÜNİVERSİTESİ</investigator_affiliation>
    <investigator_full_name>özgür yağan</investigator_full_name>
    <investigator_title>MD</investigator_title>
  </responsible_party>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Propofol</mesh_term>
    <mesh_term>Etomidate</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/NCT02186990
org study id: Odu-2
nct id: NCT02186990
lead sponsor: 
The purpose of this study is to evaluate the effect of propofol, etomidate and
      propofol-etomidate combination on hemodynamic responses during laryngoscopy and tracheal
      intubation and assess the adverse effect related to this drugs.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: Single (Outcomes Assessor)
measure: haemodynamic values
time frame: in ten minutes after intubation
description: e.g., heart rate, blood pressure (mean arterial pressure)
measure: adverse effect of study drugs
time frame: within in 30 minutes drug administration
description: e.g. myoclonus, injection pain, allergy, skin rash
arm group label: propofol
arm group type: Active Comparator
arm group label: etomidate
arm group type: Active Comparator
arm group label: propofol-etomidate
arm group type: Active Comparator
intervention type: Drug
intervention name: propofol
description: 2,5 mg/kg
arm group label: propofol-etomidate
intervention type: Drug
intervention name: etomidate
description: 0,3 mg/kg
arm group label: etomidate
intervention type: Drug
intervention name: etomidate-propofol
description: 0,15 mg/kg etomidate + 1,25 mg/kg propofol
arm group label: propofol
criteria: 
gender: All
minimum age: 18 Years
maximum age: 65 Years
healthy volunteers: No
facility: 
country: Turkey
responsible party type: Principal Investigator
investigator affiliation: T.C. ORDU ÜNİVERSİTESİ
investigator full name: özgür yağan
investigator title: MD
mesh term: Propofol
mesh term: Etomidate