<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/NCT03006211</url>
  </required_header>
  <id_info>
    <org_study_id>Asozkan-4</org_study_id>
    <nct_id>NCT03006211</nct_id>
  </id_info>
  <brief_title>The Effects of Nitrogen Protoxide and Oxygen on Corneal Endothelial in Pediatric Patients</brief_title>
  <official_title>The Effects of Nitrogen Protoxide + Sevoflurane and Oxygen + Sevoflurane Anesthesia on Corneal Endothelial in Pediatric Patients</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Inonu University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Inonu University</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      To evaluate the mean changes in Endothelial Cell and Corneal pachymetry in eyes that operated&#xD;
      under N2O + sevoflurane and O2 + sevoflurane general anesthesia.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      40 eyes of 40 patients who had extraocular surgery under general anesthesia will be included&#xD;
      in this prospective study. Cell density, Cell variatio, Hexagonality rate and pachymetry&#xD;
      specular microscopy results at before surgery and 1 week and 1 month after surgery will be&#xD;
      analyzed. O2 (1 l/min) with 50% air and N2O (1 l/min) with 50% air will be applied to each&#xD;
      group with flow rate 2 l/min totally, respectively. The duration of surgery will be recorded.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">December 2016</start_date>
  <completion_date type="Actual">April 4, 2017</completion_date>
  <primary_completion_date type="Actual">February 2017</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>Other</primary_purpose>
    <masking>Single (Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change of corneal endothal number</measure>
    <time_frame>after surgery at first day, 1th week and 1th month</time_frame>
    <description>Nitrogen protoxide and oxygen may be change this number</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change of Cell density rate</measure>
    <time_frame>after surgery at first day, 1th week and 1th month</time_frame>
    <description>Nitrogen protoxide and oxygen may be change this rate</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change of Cell variation rate</measure>
    <time_frame>at before surgery and 1 week and 1 month after surgery</time_frame>
    <description>Nitrogen protoxide and oxygen may be change this rate</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change of Hexagonality rate</measure>
    <time_frame>after surgery at first day, 1th week and 1th month</time_frame>
    <description>Nitrogen protoxide and oxygen may be change this rate</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change of pachymetry specular microscopy results</measure>
    <time_frame>after surgery at first day, 1th week and 1th month</time_frame>
    <description>Nitrogen protoxide and oxygen may be change these results</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">40</enrollment>
  <condition>Cornea</condition>
  <condition>Anesthesia; Reaction</condition>
  <arm_group>
    <arm_group_label>corneal endothal</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Evaluate the effects of nitrogen protoxide to corneal endothal and compare with oxygen.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Cell density</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Evaluate the effects of nitrogen protoxide to Cell density and compare with oxygen.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Nitrogen protoxide</intervention_name>
    <arm_group_label>Cell density</arm_group_label>
    <arm_group_label>corneal endothal</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Oxygen</intervention_name>
    <arm_group_label>Cell density</arm_group_label>
    <arm_group_label>corneal endothal</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  40 eyes of 40 pediatric patients who had extraocular surgery under general anesthesia&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  None&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>5 Years</minimum_age>
    <maximum_age>12 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <verification_date>April 2017</verification_date>
  <study_first_submitted>December 22, 2016</study_first_submitted>
  <study_first_submitted_qc>December 27, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 30, 2016</study_first_posted>
  <last_update_submitted>April 4, 2017</last_update_submitted>
  <last_update_submitted_qc>April 4, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">April 5, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Inonu University</investigator_affiliation>
    <investigator_full_name>Ahmet Selim Ozkan</investigator_full_name>
    <investigator_title>M.D.</investigator_title>
  </responsible_party>
  <keyword>nitrogen protoxide</keyword>
  <keyword>oxygen</keyword>
  <keyword>corneal endothelial</keyword>
  <keyword>pediatric</keyword>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Nitric Oxide</mesh_term>
    <mesh_term>Nitrous Oxide</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
  </patient_data>
  <!-- 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/NCT03006211
org study id: Asozkan-4
nct id: NCT03006211
lead sponsor: 
has dmc: No
To evaluate the mean changes in Endothelial Cell and Corneal pachymetry in eyes that operated
      under N2O + sevoflurane and O2 + sevoflurane general anesthesia.
40 eyes of 40 patients who had extraocular surgery under general anesthesia will be included
      in this prospective study. Cell density, Cell variatio, Hexagonality rate and pachymetry
      specular microscopy results at before surgery and 1 week and 1 month after surgery will be
      analyzed. O2 (1 l/min) with 50% air and N2O (1 l/min) with 50% air will be applied to each
      group with flow rate 2 l/min totally, respectively. The duration of surgery will be recorded.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Other
masking: Single (Investigator)
measure: Change of corneal endothal number
time frame: after surgery at first day, 1th week and 1th month
description: Nitrogen protoxide and oxygen may be change this number
measure: Change of Cell density rate
time frame: after surgery at first day, 1th week and 1th month
description: Nitrogen protoxide and oxygen may be change this rate
measure: Change of Cell variation rate
time frame: at before surgery and 1 week and 1 month after surgery
description: Nitrogen protoxide and oxygen may be change this rate
measure: Change of Hexagonality rate
time frame: after surgery at first day, 1th week and 1th month
description: Nitrogen protoxide and oxygen may be change this rate
measure: Change of pachymetry specular microscopy results
time frame: after surgery at first day, 1th week and 1th month
description: Nitrogen protoxide and oxygen may be change these results
arm group label: corneal endothal
arm group type: Active Comparator
description: Evaluate the effects of nitrogen protoxide to corneal endothal and compare with oxygen.
arm group label: Cell density
arm group type: Active Comparator
description: Evaluate the effects of nitrogen protoxide to Cell density and compare with oxygen.
intervention type: Other
intervention name: Nitrogen protoxide
arm group label: Cell density
arm group label: corneal endothal
intervention type: Other
intervention name: Oxygen
arm group label: Cell density
arm group label: corneal endothal
criteria: 
gender: All
minimum age: 5 Years
maximum age: 12 Years
healthy volunteers: No
responsible party type: Principal Investigator
investigator affiliation: Inonu University
investigator full name: Ahmet Selim Ozkan
investigator title: M.D.
mesh term: Nitric Oxide
mesh term: Nitrous Oxide
sharing ipd: Undecided