<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/NCT03003598</url>
  </required_header>
  <id_info>
    <org_study_id>Asozkan-3</org_study_id>
    <nct_id>NCT03003598</nct_id>
  </id_info>
  <brief_title>The Effects of Intubation Via McGrath Videolaryngoscope on Intraocular Pressure</brief_title>
  <official_title>The Effects of Endotracheal Intubation Via McGrath Videolaryngoscope on Intraocular Pressure</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>
      In this study, the investigators aimed to compare the effects of endotracheal intubation via&#xD;
      direct laryngoscope (DLS) and McGrath Videolaryngoscope (VL) on intraocular pressure.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Total of 50 American Society of Anesthesiologist Grade 1-2, Mallampati score 1 or 2, age&#xD;
      between 18 to 65 patient planned to undergo nonopthalmic surgery will be included to study.&#xD;
      Patients with glaucoma, diabetes mellitus, cardiovascular and pulmonary diseases, American&#xD;
      Society of Anesthesiologist Grade III and IV, Body mass index more than 35, difficult&#xD;
      intubation, undergo obstetrical surgery and propofol, fentanyl, rocuronium contraindicated&#xD;
      will be excluded from the study. Patients will be divided randomly into 2 groups as direct&#xD;
      laryngoscopic and videolaryngoscopic intubation group. Patients will be preoxygenated with&#xD;
      %100 O2 for 3 minutes then anesthesia will be induced using propofol 2 mg / kg, fentanyl 1&#xD;
      mcg/kg, and rocuronium 0,5 mg / kg in both groups. After 3 minutes mask ventilation, patients&#xD;
      will be intubated (women with No:7-7,5, men with No:8-8,5 intubation tube) by oral route.&#xD;
      systolic blood pressure, diastolic blood pressure, mean arterial pressure, peripheral oxygen&#xD;
      saturation, perfusion indexwill be recorded and intraocular pressure measured by&#xD;
      ophthalmologist by tonopen device will be recorded pre-induction (basal), after induction,&#xD;
      1,2,3,5 minutes after intubation, respectively. Period between handling of laryngoscope or&#xD;
      videolaryngoscope after termination of mask ventilation and obtain end tidal carbon dioxide&#xD;
      will be accepted as application time and recorded. Study will be terminated after 5th minute&#xD;
      values taken.&#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">January 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>Systolic blood pressure</measure>
    <time_frame>From Beginning of Anesthesia induction to 5th minutes of intubation</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Heart rate</measure>
    <time_frame>From Beginning of Anesthesia induction to 5th minutes of intubation</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Intraocular pressure</measure>
    <time_frame>From Beginning of Anesthesia induction to 5th minutes of intubation</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Adverse events</measure>
    <time_frame>within the first 24 hour after surgery</time_frame>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">50</enrollment>
  <condition>Intraocular Pressure</condition>
  <arm_group>
    <arm_group_label>Videolaryngoscopy</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Evaluate the difference between the two groups about hemodynamic and intraocular pressure responses.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Direct laryngoscopy</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Evaluate the difference between the two groups about hemodynamic and intraocular pressure responses.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Videolaryngoscope</intervention_name>
    <description>This device is used in endotracheal intubation and tonopen device for measuring of intraocular pressure. The investigators want to evaluate which one is better.</description>
    <arm_group_label>Videolaryngoscopy</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Direct laryngoscope</intervention_name>
    <description>This device is used in endotracheal intubation and tonopen device for measuring of intraocular pressure. The investigators want to evaluate which one is better.</description>
    <arm_group_label>Direct laryngoscopy</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  ASA (American Society of Anesthesiologist) Grade 1-2,&#xD;
&#xD;
          -  Mallampati score 1 or 2,&#xD;
&#xD;
          -  Age between 18 to 65,&#xD;
&#xD;
          -  Patient planned to undergo nonopthalmic surgery&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients with glaucoma, diabetes mellitus, cardiovascular and pulmonary diseases, ASA&#xD;
             Grade III and IV, BMI more than 35,&#xD;
&#xD;
          -  Patients with difficult intubation,&#xD;
&#xD;
          -  Patients undergoing obstetrical surgery and propofol, fentanyl, rocuronium&#xD;
             contraindicated&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>65 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 28, 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>Intraocular pressure</keyword>
  <keyword>videolaryngoscope</keyword>
  <keyword>direct laryngoscope</keyword>
  <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/NCT03003598
org study id: Asozkan-3
nct id: NCT03003598
lead sponsor: 
has dmc: No
In this study, the investigators aimed to compare the effects of endotracheal intubation via
      direct laryngoscope (DLS) and McGrath Videolaryngoscope (VL) on intraocular pressure.
Total of 50 American Society of Anesthesiologist Grade 1-2, Mallampati score 1 or 2, age
      between 18 to 65 patient planned to undergo nonopthalmic surgery will be included to study.
      Patients with glaucoma, diabetes mellitus, cardiovascular and pulmonary diseases, American
      Society of Anesthesiologist Grade III and IV, Body mass index more than 35, difficult
      intubation, undergo obstetrical surgery and propofol, fentanyl, rocuronium contraindicated
      will be excluded from the study. Patients will be divided randomly into 2 groups as direct
      laryngoscopic and videolaryngoscopic intubation group. Patients will be preoxygenated with
      %100 O2 for 3 minutes then anesthesia will be induced using propofol 2 mg / kg, fentanyl 1
      mcg/kg, and rocuronium 0,5 mg / kg in both groups. After 3 minutes mask ventilation, patients
      will be intubated (women with No:7-7,5, men with No:8-8,5 intubation tube) by oral route.
      systolic blood pressure, diastolic blood pressure, mean arterial pressure, peripheral oxygen
      saturation, perfusion indexwill be recorded and intraocular pressure measured by
      ophthalmologist by tonopen device will be recorded pre-induction (basal), after induction,
      1,2,3,5 minutes after intubation, respectively. Period between handling of laryngoscope or
      videolaryngoscope after termination of mask ventilation and obtain end tidal carbon dioxide
      will be accepted as application time and recorded. Study will be terminated after 5th minute
      values taken.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Other
masking: Single (Investigator)
measure: Systolic blood pressure
time frame: From Beginning of Anesthesia induction to 5th minutes of intubation
measure: Heart rate
time frame: From Beginning of Anesthesia induction to 5th minutes of intubation
measure: Intraocular pressure
time frame: From Beginning of Anesthesia induction to 5th minutes of intubation
measure: Adverse events
time frame: within the first 24 hour after surgery
arm group label: Videolaryngoscopy
arm group type: Active Comparator
description: Evaluate the difference between the two groups about hemodynamic and intraocular pressure responses.
arm group label: Direct laryngoscopy
arm group type: Active Comparator
description: Evaluate the difference between the two groups about hemodynamic and intraocular pressure responses.
intervention type: Other
intervention name: Videolaryngoscope
description: This device is used in endotracheal intubation and tonopen device for measuring of intraocular pressure. The investigators want to evaluate which one is better.
arm group label: Videolaryngoscopy
intervention type: Other
intervention name: Direct laryngoscope
description: This device is used in endotracheal intubation and tonopen device for measuring of intraocular pressure. The investigators want to evaluate which one is better.
arm group label: Direct laryngoscopy
criteria: 
gender: All
minimum age: 18 Years
maximum age: 65 Years
healthy volunteers: No
responsible party type: Principal Investigator
investigator affiliation: Inonu University
investigator full name: Ahmet Selim Ozkan
investigator title: M.D.
sharing ipd: Undecided