<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/NCT02215382</url>
  </required_header>
  <id_info>
    <org_study_id>Odu-3</org_study_id>
    <nct_id>NCT02215382</nct_id>
  </id_info>
  <brief_title>Intraocular Pressure Changes Associated With Tracheal Extubation: Comparison of Sugammadex With Conventional Reversal of Neuromuscular Blockade</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 aim of this study, comparison of effects of sugammadex versus neostigmine/atropine&#xD;
      combination on hemodynamic parameters and intraocular pressure during tracheal extubation.&#xD;
&#xD;
      This prospective, randomised study was designed to compare two reversal methods with respect&#xD;
      to changes in IOP, heart rate and blood pressure during tracheal extubation period.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>August 2014</start_date>
  <completion_date type="Actual">November 2014</completion_date>
  <primary_completion_date type="Actual">October 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>Diagnostic</primary_purpose>
    <masking>Single (Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>intraocular pressure</measure>
    <time_frame>baseline, before applying reversal agent, after applying reversal agent, one, three, five and ten minutes after tracheal extubation</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>heart rate</measure>
    <time_frame>baseline, before applying reversal agent, after applying reversal agent, one, three, five and ten minutes after tracheal extubation</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>blood pressure</measure>
    <time_frame>baseline, before applying reversal agent, after applying reversal agent, one, three, five and ten minutes after tracheal extubation</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">36</enrollment>
  <condition>Intraocular Pressure Changes During Tracheal Extubation</condition>
  <arm_group>
    <arm_group_label>sugammadex</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>neostigmine + atropine</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>sugammadex</intervention_name>
    <description>sugammadex 2 mg/kg</description>
    <arm_group_label>sugammadex</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>neostigmine+atropine</intervention_name>
    <description>neostigmine 0,05 mg/kg + atropine 0,025 mg/kg</description>
    <arm_group_label>neostigmine + atropine</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  ASA I-II physical status&#xD;
&#xD;
          -  elective surgery&#xD;
&#xD;
          -  endotracheal intubation under general anesthesia&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  emergency surgery&#xD;
&#xD;
          -  pregnancy&#xD;
&#xD;
          -  laparoscopic surgery&#xD;
&#xD;
          -  prone position&#xD;
&#xD;
          -  BMI &gt; 30 kg/m2&#xD;
&#xD;
          -  sedative drug use in last month&#xD;
&#xD;
          -  patients with glaucoma.&#xD;
&#xD;
          -  ASA &gt; II physical status&#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>August 7, 2014</study_first_submitted>
  <study_first_submitted_qc>August 12, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 13, 2014</study_first_posted>
  <last_update_submitted>April 18, 2015</last_update_submitted>
  <last_update_submitted_qc>April 18, 2015</last_update_submitted_qc>
  <last_update_posted type="Estimate">April 21, 2015</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, assistant professor</investigator_title>
  </responsible_party>
  <keyword>two reversal methods</keyword>
  <keyword>changes in IOP</keyword>
  <keyword>heart rate</keyword>
  <keyword>blood pressure</keyword>
  <keyword>tracheal extubation</keyword>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Atropine</mesh_term>
    <mesh_term>Neostigmine</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/NCT02215382
org study id: Odu-3
nct id: NCT02215382
lead sponsor: 
The aim of this study, comparison of effects of sugammadex versus neostigmine/atropine
      combination on hemodynamic parameters and intraocular pressure during tracheal extubation.

      This prospective, randomised study was designed to compare two reversal methods with respect
      to changes in IOP, heart rate and blood pressure during tracheal extubation period.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Diagnostic
masking: Single (Investigator)
measure: intraocular pressure
time frame: baseline, before applying reversal agent, after applying reversal agent, one, three, five and ten minutes after tracheal extubation
measure: heart rate
time frame: baseline, before applying reversal agent, after applying reversal agent, one, three, five and ten minutes after tracheal extubation
measure: blood pressure
time frame: baseline, before applying reversal agent, after applying reversal agent, one, three, five and ten minutes after tracheal extubation
arm group label: sugammadex
arm group type: Active Comparator
arm group label: neostigmine + atropine
arm group type: Active Comparator
intervention type: Drug
intervention name: sugammadex
description: sugammadex 2 mg/kg
arm group label: sugammadex
intervention type: Drug
intervention name: neostigmine+atropine
description: neostigmine 0,05 mg/kg + atropine 0,025 mg/kg
arm group label: neostigmine + atropine
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, assistant professor
mesh term: Atropine
mesh term: Neostigmine