<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/NCT04407715</url>
  </required_header>
  <id_info>
    <org_study_id>2018/11-0</org_study_id>
    <nct_id>NCT04407715</nct_id>
  </id_info>
  <brief_title>Anesthesia on Optic Nerve Sheath Diameter</brief_title>
  <official_title>The Effect Of Minimal and High Flow Anesthesia on Optic Nerve Sheath Diameter in Laparotomic Gynecological Surgery</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Bursa Yüksek İhtisas Education and Research Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Bursa Yüksek İhtisas Education and Research Hospital</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Different amounts of anesthetic gas can be used in the obstetric gynecological surgery&#xD;
      operations to be performed with open method. Researchers aimed to compare the effect of gas&#xD;
      changes on intraocular nerve diameter by ultrasonography.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      A total of 80 patients who underwent laparotomic gynecological surgery were divided into two&#xD;
      groups prospectively: high flow of 2 L/min and minimal flow of 0.5 L/min. Anesthesia was&#xD;
      maintained with 50% oxygen-50% air at 2 L/min and desflurane at 1.1 MAC in Group 1 (n=40) and&#xD;
      with 50% oxygen-50% air at 2 L/min and desflurane at 1.1 MAC in Group 2 (n=40). After 10-15&#xD;
      minutes, group 2 was administered minimal flow with 50-60% oxygen-40-50% air at 0.5 L/min and&#xD;
      desflurane, and 10 minutes before the end of the surgery, the patients were switched to high&#xD;
      flow with 50% oxygen-50% air at 2 L/min.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">April 30, 2019</start_date>
  <completion_date type="Actual">December 30, 2019</completion_date>
  <primary_completion_date type="Actual">October 30, 2019</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>
    <intervention_model_description>A total of 80 patients who underwent laparotomic gynecological surgery were divided into two groups prospectively: high flow of 2 L/min and minimal flow of 0.5 L/min. Anesthesia was maintained with 50% oxygen-50% air at 2 L/min and desflurane at 1.1 MAC in Group 1 (n=40) and with 50% oxygen-50% air at 2 L/min and desflurane at 1.1 MAC in Group 2 (n=40). After 10-15 minutes, group 2 was administered minimal flow with 50-60% oxygen-40-50% air at 0.5 L/min and desflurane, and 10 minutes before the end of the surgery, the patients were switched to high flow with 50% oxygen-50% air at 2 L/min.</intervention_model_description>
    <primary_purpose>Diagnostic</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Optic Nerve Sheath Diamater</measure>
    <time_frame>2 hours operation time</time_frame>
    <description>Optic nerve sheath diamater measurements of the patients were recorded before and during the surgery at specified time points (T0: awake, T1: High fresh gas flow after induction at the 10th min., T2: Inhalation anesthesia at the 30th min., T3: Inhalation anesthesia at the 60th min., T4: Inhalation anesthesia at the 90th min., T5: Before extubation).A typical optic nerve sheath is generally less than 5 mm in diameter, and diameters greater than 5.5 mm predict an ICP of ≥20 cm H2O with 100% sensitivity and specifity</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Peroperative Complications</measure>
    <time_frame>2 hours operation time</time_frame>
    <description>Complications during the surgery (decreased oxygen levels, hypercapnia, hypotension, hypertension, bradycardia, tachycardia, rhythm disorders) were recorded.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Postoperative Complications</measure>
    <time_frame>postop 20 minutes</time_frame>
    <description>Complications in the recovery room (respiratory distress, decreased oxygen levels, hypotension, hypertension, bradycardia, tachycardia, vomiting, rhythm disorders) were recorded.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">80</enrollment>
  <condition>Optic Nerve Sheath Diameter</condition>
  <arm_group>
    <arm_group_label>High Flow Anesthesia, Low Flow Anesthesia</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>. The patients were randomly allocated to one of the two groups of fresh gas flows using the closed-envelope technique: 2 L/min high flow and 0.5 L/min minimal flow. Group 1 (n = 40) was operated under high flow anesthesia with 50% O2 - 50% air at 2 L/min and desflurane at 1.1 MAC for the duration of the surgery. For anesthesia maintenance, Group 2 (n=40) was administered 50% oxygen - 50% air at 2 L/min and desflurane for 10-15 minutes. After reaching 1.1 MAC, it was switched to minimal flow with 50-60% oxygen- 40-50% air at 0.5 L/min and desflurane. 10 minutes before the end of the surgery, it was switched to high flow with 50% oxygen -50% air at 2 L/min.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Peroperetive Optic Nerve Sheath Diameter</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Optic nerve sheath diameter measurements were performed by an experienced and the same anesthetist. In the measurements, the GE Healthcare Logiq e series USG device and 12-MHz linear probe were used. Longitudinal and transverse axis images were obtained on both eyelids while the patient was in the supine position. Measurements were taken 3 mm behind the optic nerve head</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>The Effect Of Minimal and High Flow Anesthesia on Optic Nerve Sheath Diamater</intervention_name>
    <description>The patients were randomly allocated to one of the two groups of fresh gas flows using the closed-envelope technique: 2 L/min high flow and 0.5 L/min minimal flow.</description>
    <arm_group_label>High Flow Anesthesia, Low Flow Anesthesia</arm_group_label>
    <arm_group_label>Peroperetive Optic Nerve Sheath Diameter</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Aged 18-65 years&#xD;
&#xD;
          -  ASA I-II&#xD;
&#xD;
          -  Who underwent laparotomic gynecological surgery&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients with obstructive pulmonary disease&#xD;
&#xD;
          -  Patients with decompensated diabetes, those with a fasting period of more than 12&#xD;
             hours -Acute alcohol intoxication&#xD;
&#xD;
          -  Chronic alcohol use&#xD;
&#xD;
          -  Who refuse to participate in the study&#xD;
&#xD;
          -  Who are not cooperative, do not speak Turkish&#xD;
&#xD;
          -  Who had known eye disease (glaucoma, retinal detachment), had a previous history of&#xD;
             eye surgery,&#xD;
&#xD;
          -  Increased intracranial pressure findings (intracranial lesion, previous&#xD;
             cerebrovascular diseases&#xD;
&#xD;
          -  Body mass index of &gt; 40kg/m2&#xD;
&#xD;
          -  ASA &gt; III&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Anıl Onur, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Health Science Bursa Yüksek Ihtisas Training and Research Hospital</affiliation>
  </overall_official>
  <overall_official>
    <last_name>H.Erkan Sayan, MD</last_name>
    <role>Study Director</role>
    <affiliation>University of Health Science Bursa Yüksek Ihtisas Training and Research Hospital</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Tugba Onur, MD</last_name>
    <role>Study Chair</role>
    <affiliation>University of Health Science Bursa Yüksek Ihtisas Training and Research Hospital</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Umran Karaca, MD</last_name>
    <role>Study Chair</role>
    <affiliation>University of Health Science Bursa Yüksek Ihtisas Training and Research Hospital</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Canan Yılmaz, MD</last_name>
    <role>Study Chair</role>
    <affiliation>University of Health Science Bursa Yüksek Ihtisas Training and Research Hospital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University of Health Sciences Bursa Yüksek İhtisas Training and Research Hospital</name>
      <address>
        <city>Bursa</city>
        <country>Turkey</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Turkey</country>
  </location_countries>
  <verification_date>May 2020</verification_date>
  <study_first_submitted>March 10, 2020</study_first_submitted>
  <study_first_submitted_qc>May 26, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">May 29, 2020</study_first_posted>
  <last_update_submitted>May 26, 2020</last_update_submitted>
  <last_update_submitted_qc>May 26, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">May 29, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Bursa Yüksek İhtisas Education and Research Hospital</investigator_affiliation>
    <investigator_full_name>Anıl Onur</investigator_full_name>
    <investigator_title>Principle İnvestigator</investigator_title>
  </responsible_party>
  <keyword>Minimal Flow Anesthesia</keyword>
  <keyword>Optic Nerve Sheath Diameter</keyword>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Anesthetics</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>No</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/NCT04407715
org study id: 2018/11-0
nct id: NCT04407715
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Different amounts of anesthetic gas can be used in the obstetric gynecological surgery
      operations to be performed with open method. Researchers aimed to compare the effect of gas
      changes on intraocular nerve diameter by ultrasonography.
A total of 80 patients who underwent laparotomic gynecological surgery were divided into two
      groups prospectively: high flow of 2 L/min and minimal flow of 0.5 L/min. Anesthesia was
      maintained with 50% oxygen-50% air at 2 L/min and desflurane at 1.1 MAC in Group 1 (n=40) and
      with 50% oxygen-50% air at 2 L/min and desflurane at 1.1 MAC in Group 2 (n=40). After 10-15
      minutes, group 2 was administered minimal flow with 50-60% oxygen-40-50% air at 0.5 L/min and
      desflurane, and 10 minutes before the end of the surgery, the patients were switched to high
      flow with 50% oxygen-50% air at 2 L/min.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: A total of 80 patients who underwent laparotomic gynecological surgery were divided into two groups prospectively: high flow of 2 L/min and minimal flow of 0.5 L/min. Anesthesia was maintained with 50% oxygen-50% air at 2 L/min and desflurane at 1.1 MAC in Group 1 (n=40) and with 50% oxygen-50% air at 2 L/min and desflurane at 1.1 MAC in Group 2 (n=40). After 10-15 minutes, group 2 was administered minimal flow with 50-60% oxygen-40-50% air at 0.5 L/min and desflurane, and 10 minutes before the end of the surgery, the patients were switched to high flow with 50% oxygen-50% air at 2 L/min.
primary purpose: Diagnostic
masking: None (Open Label)
measure: Optic Nerve Sheath Diamater
time frame: 2 hours operation time
description: Optic nerve sheath diamater measurements of the patients were recorded before and during the surgery at specified time points (T0: awake, T1: High fresh gas flow after induction at the 10th min., T2: Inhalation anesthesia at the 30th min., T3: Inhalation anesthesia at the 60th min., T4: Inhalation anesthesia at the 90th min., T5: Before extubation).A typical optic nerve sheath is generally less than 5 mm in diameter, and diameters greater than 5.5 mm predict an ICP of ≥20 cm H2O with 100% sensitivity and specifity
measure: Peroperative Complications
time frame: 2 hours operation time
description: Complications during the surgery (decreased oxygen levels, hypercapnia, hypotension, hypertension, bradycardia, tachycardia, rhythm disorders) were recorded.
measure: Postoperative Complications
time frame: postop 20 minutes
description: Complications in the recovery room (respiratory distress, decreased oxygen levels, hypotension, hypertension, bradycardia, tachycardia, vomiting, rhythm disorders) were recorded.
arm group label: High Flow Anesthesia, Low Flow Anesthesia
arm group type: Placebo Comparator
description: . The patients were randomly allocated to one of the two groups of fresh gas flows using the closed-envelope technique: 2 L/min high flow and 0.5 L/min minimal flow. Group 1 (n = 40) was operated under high flow anesthesia with 50% O2 - 50% air at 2 L/min and desflurane at 1.1 MAC for the duration of the surgery. For anesthesia maintenance, Group 2 (n=40) was administered 50% oxygen - 50% air at 2 L/min and desflurane for 10-15 minutes. After reaching 1.1 MAC, it was switched to minimal flow with 50-60% oxygen- 40-50% air at 0.5 L/min and desflurane. 10 minutes before the end of the surgery, it was switched to high flow with 50% oxygen -50% air at 2 L/min.
arm group label: Peroperetive Optic Nerve Sheath Diameter
arm group type: Active Comparator
description: Optic nerve sheath diameter measurements were performed by an experienced and the same anesthetist. In the measurements, the GE Healthcare Logiq e series USG device and 12-MHz linear probe were used. Longitudinal and transverse axis images were obtained on both eyelids while the patient was in the supine position. Measurements were taken 3 mm behind the optic nerve head
intervention type: Procedure
intervention name: The Effect Of Minimal and High Flow Anesthesia on Optic Nerve Sheath Diamater
description: The patients were randomly allocated to one of the two groups of fresh gas flows using the closed-envelope technique: 2 L/min high flow and 0.5 L/min minimal flow.
arm group label: High Flow Anesthesia, Low Flow Anesthesia
arm group label: Peroperetive Optic Nerve Sheath Diameter
criteria: 
gender: All
minimum age: 18 Years
maximum age: 65 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Anıl Onur, MD
role: Principal Investigator
affiliation: University of Health Science Bursa Yüksek Ihtisas Training and Research Hospital
last name: H.Erkan Sayan, MD
role: Study Director
affiliation: University of Health Science Bursa Yüksek Ihtisas Training and Research Hospital
last name: Tugba Onur, MD
role: Study Chair
affiliation: University of Health Science Bursa Yüksek Ihtisas Training and Research Hospital
last name: Umran Karaca, MD
role: Study Chair
affiliation: University of Health Science Bursa Yüksek Ihtisas Training and Research Hospital
last name: Canan Yılmaz, MD
role: Study Chair
affiliation: University of Health Science Bursa Yüksek Ihtisas Training and Research Hospital
facility: 
country: Turkey
responsible party type: Principal Investigator
investigator affiliation: Bursa Yüksek İhtisas Education and Research Hospital
investigator full name: Anıl Onur
investigator title: Principle İnvestigator
mesh term: Anesthetics
sharing ipd: No