<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/NCT03003585</url>
  </required_header>
  <id_info>
    <org_study_id>Asozkan-2</org_study_id>
    <nct_id>NCT03003585</nct_id>
  </id_info>
  <brief_title>Effects of Direct Laryngoscopic and Fiberoptic Intubation on Intraocular Pressure</brief_title>
  <official_title>Comparison of Effects of Direct Laryngoscopic and Fiberoptic Oral Endotracheal Intubation 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 direct laryngoscopic and&#xD;
      fiberoptic endotracheal intubation on intraocular pressure.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Material and Method: Total of 54 American Society of Anesthesiologist Grade 1-2, Mallampati&#xD;
      score 1 or 2, age between 18 to 65 patient planned to undergo nonopthalmic surgery will be&#xD;
      included to study. Patients with glaucoma, diabetes mellitus, cardiovascular and pulmonary&#xD;
      diseases, American Society of Anesthesiologist Grade III and IV, body mass index more than&#xD;
      35, difficult intubation, undergo obstetrical surgery and propofol, fentanyl, rocuronium&#xD;
      contraindicated will be excluded from the study. Patients will be divided randomly into 2&#xD;
      groups as direct laryngoscopic and fiberoptic intubation group. Patients will be&#xD;
      preoxygenated with %100 O2 for 3 minutes then anesthesia will be induced using propofol 2 mg&#xD;
      / kg, fentanyl 1 mcg/kg, and rocuronium 0,5 mg / kg in both groups. After 3 minutes mask&#xD;
      ventilation, patients will be intubated (women with No:7-7,5, men with No:8-8,5 intubation&#xD;
      tube). Systolic blood pressure, diastolic blood pressure, mean arterial pressure, peripheral&#xD;
      oxygen saturation,perfusion index will 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;
      fiberoptic device after termination of mask ventilation and obtain end tidal CO2 will be&#xD;
      accepted as application time and recorded. Study will be terminated after 5th minute values&#xD;
      taken.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>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>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>Adverse events</measure>
    <time_frame>within the first 24 hour after surgery</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>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">54</enrollment>
  <condition>Intraocular Pressure</condition>
  <condition>Intubation Complication</condition>
  <arm_group>
    <arm_group_label>Fiberoptic bronchoscopy</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>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>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Fiberoptic bronchoscope</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>Fiberoptic bronchoscopy</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>direct laryngoscopy</keyword>
  <keyword>fiberoptic bronchoscopy</keyword>
  <!-- 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/NCT03003585
org study id: Asozkan-2
nct id: NCT03003585
lead sponsor: 
has dmc: No
In this study, the investigators aimed to compare the effects of direct laryngoscopic and
      fiberoptic endotracheal intubation on intraocular pressure.
Material and Method: Total of 54 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 fiberoptic 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). Systolic blood pressure, diastolic blood pressure, mean arterial pressure, peripheral
      oxygen saturation,perfusion index will 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
      fiberoptic device after termination of mask ventilation and obtain end tidal CO2 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: Adverse events
time frame: within the first 24 hour after surgery
measure: Intraocular pressure
time frame: From Beginning of Anesthesia induction to 5th minutes of intubation
arm group label: Fiberoptic bronchoscopy
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: 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
intervention type: Other
intervention name: Fiberoptic bronchoscope
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: Fiberoptic bronchoscopy
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.