<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/NCT03760692</url>
  </required_header>
  <id_info>
    <org_study_id>351-SBKAEK</org_study_id>
    <secondary_id>HUSE 012-ANR-2017</secondary_id>
    <nct_id>NCT03760692</nct_id>
  </id_info>
  <brief_title>I-gel vs Ambu AuraGain in Laparoscopic Gynecological Surgery</brief_title>
  <official_title>Comparison of I-gel and Ambu AuraGain Without Neuromuscular Blocker in Laparoscopic Gynecological Surgery</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Dokuz Eylul University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Dokuz Eylul University</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>
      To compare the effects of i-gel and Ambu AuraGain on ventilation parameters and surgical view&#xD;
      during Trendelenburg position laparoscopic gynecological surgery in cases administered&#xD;
      positive pressure ventilation without the use of neuromuscular agents.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Prospective, multicenter, randomized and double-blind study, aged from 18 to 65 years&#xD;
      undergoing elective laparoscopic gynecological surgery.&#xD;
&#xD;
      The patients are randomly assigned to 2 groups:&#xD;
&#xD;
      Group i-gel Group Ambu AuraGain&#xD;
&#xD;
      Procedure:&#xD;
&#xD;
      The investigation protocol contains the following sections:&#xD;
&#xD;
        1. Induction of anaesthesia. For preoperative sedation 0.02 mg/kg midazolam IV will be&#xD;
           administered. 2 minutes of 0.2 µ/kg/min remifentanil and 6 mg kg st-1 propofol infusion,&#xD;
           IV 1-2 mg kg-1 propofol . No muscle relaxant will be used for insertion of the airway&#xD;
           device.&#xD;
&#xD;
        2. Bispectral index values will be held between 40-60.Bispectral index values will be&#xD;
           within this interval by increasing or decreasing propofol infusion by 1 mg/kg after&#xD;
           additional bolus dose of propofol (1 mg/kg).&#xD;
&#xD;
        3. Insertion of the airway device. The size of the airway device used is based on the&#xD;
           manufacturers' recommendations.&#xD;
&#xD;
        4. Anesthesia maintenance will be ensured by 50% O2/air with 0.1-0.4 µ kg/min-1&#xD;
           remifentanil and 4-10 mg/kg/hr propofol IV infusion&#xD;
&#xD;
        5. Functionality of the gastric drainage channel of the airway device&#xD;
&#xD;
        6. Measurement of airway seal pressure (oropharyngeal leak pressure (OLP): at baseline, and&#xD;
           at 2 minutes after airway device insertion (T1), 10 minutes after insufflation (T2),&#xD;
           before desufflation (T3), before removal of airway device (T4). The maximum pressure&#xD;
           allowed is 40 cm H2O.&#xD;
&#xD;
        7. Ventilatory mechanics and parameters and hemodynamic parameters are measured at&#xD;
           baseline, and at T1, T2, T3 and T4.&#xD;
&#xD;
        8. Perioperative complications: Cough, vomiting, laryngeal spasm, laryngeal Stridor, airway&#xD;
           intervention requirements, hypoxia (SpO2 &lt; 92%)&#xD;
&#xD;
        9. Removal of the airway device: Presence of blood - 3 level grading (1:no blood; 2: trace&#xD;
           amounts of blood; 3: clear amounts of blood). Complications: sore throat ( VAS:10-point&#xD;
           scale), dysphonia (yes/no), dysphagia (yes/no).&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Enrolling by invitation</overall_status>
  <start_date type="Actual">November 1, 2018</start_date>
  <completion_date type="Anticipated">December 1, 2024</completion_date>
  <primary_completion_date type="Anticipated">November 1, 2024</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>Prospective, multicenter, randomized</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Double (Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Insertion time</measure>
    <time_frame>intraoperative</time_frame>
    <description>The time taken to successfully place the device in seconds</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in airway seal pressure</measure>
    <time_frame>intraoperative</time_frame>
    <description>The maximum oropharyngeal leak pressure attained for each device.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Number of attempts at insertion</measure>
    <time_frame>intraoperative</time_frame>
    <description>The number of repeated attempts required for successfully placing the device. Each device was given a chance of 3 attempts if still unsuccessful after 3 attempts another device was placed.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">102</enrollment>
  <condition>Airway Morbidity</condition>
  <condition>Anesthesia</condition>
  <arm_group>
    <arm_group_label>Group i-gel</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Insertion of the airway device. The size of the airway device used is based on the manufacturers' recommendations and evaluation of its clinical performance</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Group Ambu Auragain</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Insertion of the airway device. The size of the airway device used is based on the manufacturers' recommendations and evaluation of its clinical performance</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>i-gel</intervention_name>
    <description>Evaluation of clinical performance in terms of insertion, ventilation and complications</description>
    <arm_group_label>Group i-gel</arm_group_label>
    <other_name>Group i-gel</other_name>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Ambu AuroGain</intervention_name>
    <description>Evaluation of clinical performance in terms of insertion, ventilation and complications</description>
    <arm_group_label>Group Ambu Auragain</arm_group_label>
    <other_name>Group Ambu AuroGain</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  ASA classification I-II&#xD;
&#xD;
          -  Between 18-65 years&#xD;
&#xD;
          -  Undergoing elective laparoscopic gynecological surgery&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Those with any neck or upper respiratory tract pathology&#xD;
&#xD;
          2. Those at risk of gastric content regurgitation/aspiration (previous upper GIS surgery,&#xD;
             known hiatus hernia, gastroesophageal reflux, history of peptic ulcers, full stomach,&#xD;
             pregnancy)&#xD;
&#xD;
          3. Those with low pulmonary compliance or high airway resistance (chronic pulmonary&#xD;
             diseases)&#xD;
&#xD;
          4. Obese patients (BMI &gt;35)&#xD;
&#xD;
          5. Those with throat pain, dysphagia and dysphonia&#xD;
&#xD;
          6. Those with possible or previous difficult airway&#xD;
&#xD;
          7. Those with operations planned for longer than 4 hours&#xD;
&#xD;
          8. Conversion to laparotomy&#xD;
&#xD;
          9. Neuromuscular blocking agent used&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Sule Ozbilgin, MD</last_name>
    <role>Study Director</role>
    <affiliation>Dokuz Eylul University, School of Medicine, Department of Anesthesiology and Intensive Care</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Sureste University Hospital, Department of Anesthesiology and Critical Care</name>
      <address>
        <city>Madrid</city>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Dokuz Eylul University, School of Medicine, Department of Anesthesiology and Intensive Care</name>
      <address>
        <city>Izmir</city>
        <country>Turkey</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Spain</country>
    <country>Turkey</country>
  </location_countries>
  <verification_date>March 2022</verification_date>
  <study_first_submitted>November 27, 2018</study_first_submitted>
  <study_first_submitted_qc>November 29, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">November 30, 2018</study_first_posted>
  <last_update_submitted>March 25, 2022</last_update_submitted>
  <last_update_submitted_qc>March 25, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">March 28, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Dokuz Eylul University</investigator_affiliation>
    <investigator_full_name>Sule Ozbilgin</investigator_full_name>
    <investigator_title>Director</investigator_title>
  </responsible_party>
  <keyword>supraglottic airway device</keyword>
  <keyword>laparoscopic gynecological surgery</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/NCT03760692
org study id: 351-SBKAEK
secondary id: HUSE 012-ANR-2017
nct id: NCT03760692
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
To compare the effects of i-gel and Ambu AuraGain on ventilation parameters and surgical view
      during Trendelenburg position laparoscopic gynecological surgery in cases administered
      positive pressure ventilation without the use of neuromuscular agents.
Prospective, multicenter, randomized and double-blind study, aged from 18 to 65 years
      undergoing elective laparoscopic gynecological surgery.

      The patients are randomly assigned to 2 groups:

      Group i-gel Group Ambu AuraGain

      Procedure:

      The investigation protocol contains the following sections:

        1. Induction of anaesthesia. For preoperative sedation 0.02 mg/kg midazolam IV will be
           administered. 2 minutes of 0.2 µ/kg/min remifentanil and 6 mg kg st-1 propofol infusion,
           IV 1-2 mg kg-1 propofol . No muscle relaxant will be used for insertion of the airway
           device.

        2. Bispectral index values will be held between 40-60.Bispectral index values will be
           within this interval by increasing or decreasing propofol infusion by 1 mg/kg after
           additional bolus dose of propofol (1 mg/kg).

        3. Insertion of the airway device. The size of the airway device used is based on the
           manufacturers' recommendations.

        4. Anesthesia maintenance will be ensured by 50% O2/air with 0.1-0.4 µ kg/min-1
           remifentanil and 4-10 mg/kg/hr propofol IV infusion

        5. Functionality of the gastric drainage channel of the airway device

        6. Measurement of airway seal pressure (oropharyngeal leak pressure (OLP): at baseline, and
           at 2 minutes after airway device insertion (T1), 10 minutes after insufflation (T2),
           before desufflation (T3), before removal of airway device (T4). The maximum pressure
           allowed is 40 cm H2O.

        7. Ventilatory mechanics and parameters and hemodynamic parameters are measured at
           baseline, and at T1, T2, T3 and T4.

        8. Perioperative complications: Cough, vomiting, laryngeal spasm, laryngeal Stridor, airway
           intervention requirements, hypoxia (SpO2 < 92%)

        9. Removal of the airway device: Presence of blood - 3 level grading (1:no blood; 2: trace
           amounts of blood; 3: clear amounts of blood). Complications: sore throat ( VAS:10-point
           scale), dysphonia (yes/no), dysphagia (yes/no).
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: Prospective, multicenter, randomized
primary purpose: Treatment
masking: Double (Investigator, Outcomes Assessor)
measure: Insertion time
time frame: intraoperative
description: The time taken to successfully place the device in seconds
measure: Change in airway seal pressure
time frame: intraoperative
description: The maximum oropharyngeal leak pressure attained for each device.
measure: Number of attempts at insertion
time frame: intraoperative
description: The number of repeated attempts required for successfully placing the device. Each device was given a chance of 3 attempts if still unsuccessful after 3 attempts another device was placed.
arm group label: Group i-gel
arm group type: Active Comparator
description: Insertion of the airway device. The size of the airway device used is based on the manufacturers' recommendations and evaluation of its clinical performance
arm group label: Group Ambu Auragain
arm group type: Experimental
description: Insertion of the airway device. The size of the airway device used is based on the manufacturers' recommendations and evaluation of its clinical performance
intervention type: Device
intervention name: i-gel
description: Evaluation of clinical performance in terms of insertion, ventilation and complications
arm group label: Group i-gel
other name: Group i-gel
intervention type: Device
intervention name: Ambu AuroGain
description: Evaluation of clinical performance in terms of insertion, ventilation and complications
arm group label: Group Ambu Auragain
other name: Group Ambu AuroGain
criteria: 
gender: Female
minimum age: 18 Years
maximum age: 65 Years
healthy volunteers: No
last name: Sule Ozbilgin, MD
role: Study Director
affiliation: Dokuz Eylul University, School of Medicine, Department of Anesthesiology and Intensive Care
facility: 
facility: 
country: Spain
country: Turkey
responsible party type: Principal Investigator
investigator affiliation: Dokuz Eylul University
investigator full name: Sule Ozbilgin
investigator title: Director
sharing ipd: Undecided