<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/NCT03003377</url>
  </required_header>
  <id_info>
    <org_study_id>CETSEVOREM</org_study_id>
    <nct_id>NCT03003377</nct_id>
  </id_info>
  <brief_title>Sevoflurane-remifentanil EC50 (The 50% Effective Concentration) Values for LMA-Supreme Versus LMA ProSeal Insertion</brief_title>
  <official_title>Comparison of the Sevoflurane EC50 Values for Laryngeal Mask Airway Supreme Versus Laryngeal Mask Airway ProSeal Insertion During Target-controlled Infusion of Remifentanil. A Randomized Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Hospital General Universitario Gregorio Marañon</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Hospital General Universitario Gregorio Marañon</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The study was designed to determine and compare the sevoflurane EC50 optimal concentration&#xD;
      for laryngeal mask airway Supreme versus laryngeal mask airway ProSeal insertion during&#xD;
      target-controlled infusion of remifentanil.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Since the introduction of the laryngeal mask airway (LMA), a number of new supraglottic&#xD;
      airway devices as the LMA-Supreme (LMAS) and the LMA ProSeal (LMAP) have been developed for&#xD;
      the management of the airway during general anesthesia, and specifically in the context of&#xD;
      day surgery. ProSeal laryngeal mask airway is a reusable device designed to separate the&#xD;
      gastrointestinal and respiratory tracts, thereby improving the airway seal pressure and&#xD;
      allowing for controlled ventilation more efficiently tan classic LMA. The LMAS was developed&#xD;
      in 2007 as a single-use device provided with gastric canal, and combine the features of both&#xD;
      intubating LMA and the LMAP. Recently, there has been a growing interest in these devices&#xD;
      because of favourable studies obtained in several anaesthetic contexts that have proven their&#xD;
      effectiveness and safety. Even though insertion of both devices were associated with a higher&#xD;
      initial success rate, fewer airway manipulations and a safe and effective airway during&#xD;
      anaesthesia, the anaesthetic techniques for its insertion were not standardised. Most&#xD;
      available data on the requirements of anaesthetic drugs and co-induction agents used for&#xD;
      insertion of both devices originate from research involving other assessments of the LMAs&#xD;
      such as the seal respiratory and gastrointestinal tract. Investigators tested for differences&#xD;
      in the predicted concentration of sevoflurane with remifentanil for the insertion of the LMAS&#xD;
      vs. LMAP.&#xD;
&#xD;
      Methods: 45 patients American Society of Anesthesiologists (ASA) class I or II aged 20-60&#xD;
      years undergoing ambulatory elective surgery were randomized to either the LMAS or LMAP. The&#xD;
      patients were premedicated with midazolam 1 mg iv before surgery. All patients were&#xD;
      preoxygenated using 100% oxygen with a normal tidal volumen for 3 min. The circuit was primed&#xD;
      with sevoflurane 5% at a fresh gas flow of 6 L/min for 1 min. Anaesthesia was induced with&#xD;
      inhaled sevoflurane up to 5% in oxygen via facemask with fresh gas flow at 6 L/min.&#xD;
      Simultaneously remifentanil at an effect-site of 4 ng/ml was started. Target-controlled&#xD;
      infusions was used (Alaris PK) for remifentanil administration. After loss of consciousness,&#xD;
      the inspired concentration of sevoflurane was changed to obtain a predetermined end-tidal&#xD;
      concentration. A single experienced anaesthetist in the use of supraglottic devices inserted&#xD;
      the devices according to the manufacturer's recommendations. The LMAs size was chosen&#xD;
      according to the sex of the patients, size 4 for women and size 5 for men; however for&#xD;
      patients weighing ≤50 kg a size 3 was inserted. Neuromuscular blocking agents were not given.&#xD;
      Two nurses, who were blinded to the anaesthetic concentration, classified responses by the&#xD;
      patient to LMA insertion as either &quot;movement&quot; or &quot;not movement&quot;. Assesment was made for jaw&#xD;
      relaxation and graded with Muzi score. A Muzi score &gt;2 was defined as a failure of insertion.&#xD;
      The end-tidal (ET) sevoflurane concentration used for each patient was determined using the&#xD;
      Dixon's up-and-down method. The ratio of the end-tidal to predetermined end-tidal&#xD;
      concentrations was maintained at 0.9-1.0 for at least 10 minutes to establish equilibration&#xD;
      before device insertion was attempted. The first patient received a 2.5% sevoflurane&#xD;
      concentration and the step size of increase/decrease was 0.5%. If the supraglottic device&#xD;
      (LMAS or LMAP) insertion was successful, sevoflurane concentration for the next patient was&#xD;
      decrease by 0.5%. If not, sevoflurane concentration was increased by the same amount for the&#xD;
      next patient. For their comfort, patients experiencing movement received a 1-2 mg/kg bolus&#xD;
      dose of propofol.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>November 2014</start_date>
  <completion_date type="Actual">October 2015</completion_date>
  <primary_completion_date type="Actual">October 2015</primary_completion_date>
  <phase>Phase 4</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>Treatment</primary_purpose>
    <masking>Double (Participant, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>To compare the the minimum alveolar anesthetic concentration (determined at 1 atmosphere, that prevents movement in 50% of patients to LMAS vs. LMAP insertion) of sevoflurane with simultaneous remifentanil infusion in adult patients.</measure>
    <time_frame>The sevoflurane concentration is obtained during the insertion of the LMAS or LMAP in patients, after anesthesia induction</time_frame>
    <description>To compare the concentration of sevoflurane with concomitant remifentanil infusion required for LMAS insertion vs. the concentration of sevoflurane with concomitant remifentanil infusion required for LMAP insertion.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Blood pressure in mmHg</measure>
    <time_frame>Baseline and every 3 minutes until 6 minutes after insertion of the LMAs</time_frame>
    <description>To compare the evolution of blood pressure during insertion of LMAS group versus LMAP group</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Heart rate in bpm,</measure>
    <time_frame>Before and after LMAs insertion (every minute until 6 minutes)</time_frame>
    <description>To compare the evolution of heart rate during insertion of LMAS group versus LMAP group</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>BIS data, number from 100 (awake) to 40-45 (anesthetic status)</measure>
    <time_frame>Before and after LMAs insertion (every minute until 6 minutes)</time_frame>
    <description>To compare the evolution of BIS values during insertion of LMAS group versus LMAP group</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">45</enrollment>
  <condition>Sevoflurane</condition>
  <arm_group>
    <arm_group_label>Device: laryngeal mask supreme</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Determine the Sevoflurane concentration associate with remifentanil for the insertion of the laryngeal mask supreme</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Device: laryngeal mask proseal</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Determine the Sevoflurane concentration associate with remifentanil for insertion of the laryngeal mask ProSeal</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>laryngeal mask supreme</intervention_name>
    <description>Sevoflurane was administered by facial mask with concomitant remifentanil administration (at an effect-site of 4 ng/ml). The LMAS was inserted according to the manufacturer's recommendations with the patient's head in the neutral position. After equilibrium the LMAS was inserted and secured according to the manufacturer's recommendations, without using muscle relaxants. A single measurement will be obtained from each patient. If the patient reacted with movement, a 1-2 mg/kg dose of Propofol was administered.</description>
    <arm_group_label>Device: laryngeal mask supreme</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>laryngeal mask proseal</intervention_name>
    <description>Sevoflurane was administered by facial mask with concomitant remifentanil administration (at an effect-site of 4 ng/ml).The LMAP was inserted according to the manufacturer's recommendations with the patient's head in the neutral position. After equilibrium the LMAP was inserted and secured according to the manufacturer's recommendations, without using muscle relaxants. A single measurement will be obtained from each patient. If the patient reacted with movement, a 1-2 mg/kg dose of Propofol was administered.</description>
    <arm_group_label>Device: laryngeal mask proseal</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  ASA I-II patients&#xD;
&#xD;
          -  Scheduled to ambulatory surgery&#xD;
&#xD;
          -  Need for general anaesthesia&#xD;
&#xD;
          -  General anaesthesia usually performed with laryngeal mask&#xD;
&#xD;
          -  Negative pregnancy test in women&#xD;
&#xD;
          -  Signed inform consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients with a potentially difficult airway (Mallampati III or IV, a limited mouth&#xD;
             opening and/or cervical spine disease)&#xD;
&#xD;
          -  Patients with reactive airway disease&#xD;
&#xD;
          -  Signs of upper respiratory infection&#xD;
&#xD;
          -  Patients who had a risk of gastric aspiration&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>60 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Maite López-Gil, MD, PhD</last_name>
    <role>Study Chair</role>
    <affiliation>Servicio de Anestesiología, Hospital General Universitario Gregorio Marañón</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Servicio de Anestesia, Hospital General Universitario Gregorio Marañón</name>
      <address>
        <city>Madrid</city>
        <zip>28007</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Spain</country>
  </location_countries>
  <verification_date>December 2016</verification_date>
  <study_first_submitted>November 15, 2016</study_first_submitted>
  <study_first_submitted_qc>December 21, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 28, 2016</study_first_posted>
  <last_update_submitted>December 28, 2016</last_update_submitted>
  <last_update_submitted_qc>December 28, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">December 29, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Hospital General Universitario Gregorio Marañon</investigator_affiliation>
    <investigator_full_name>Matilde Zaballos</investigator_full_name>
    <investigator_title>Clinical professor</investigator_title>
  </responsible_party>
  <keyword>Sevoflurane</keyword>
  <keyword>Remifentanil</keyword>
  <keyword>Laryngeal mask supreme</keyword>
  <keyword>laryngeal mask proseal</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/NCT03003377
org study id: CETSEVOREM
nct id: NCT03003377
lead sponsor: 
has dmc: Yes
The study was designed to determine and compare the sevoflurane EC50 optimal concentration
      for laryngeal mask airway Supreme versus laryngeal mask airway ProSeal insertion during
      target-controlled infusion of remifentanil.
Since the introduction of the laryngeal mask airway (LMA), a number of new supraglottic
      airway devices as the LMA-Supreme (LMAS) and the LMA ProSeal (LMAP) have been developed for
      the management of the airway during general anesthesia, and specifically in the context of
      day surgery. ProSeal laryngeal mask airway is a reusable device designed to separate the
      gastrointestinal and respiratory tracts, thereby improving the airway seal pressure and
      allowing for controlled ventilation more efficiently tan classic LMA. The LMAS was developed
      in 2007 as a single-use device provided with gastric canal, and combine the features of both
      intubating LMA and the LMAP. Recently, there has been a growing interest in these devices
      because of favourable studies obtained in several anaesthetic contexts that have proven their
      effectiveness and safety. Even though insertion of both devices were associated with a higher
      initial success rate, fewer airway manipulations and a safe and effective airway during
      anaesthesia, the anaesthetic techniques for its insertion were not standardised. Most
      available data on the requirements of anaesthetic drugs and co-induction agents used for
      insertion of both devices originate from research involving other assessments of the LMAs
      such as the seal respiratory and gastrointestinal tract. Investigators tested for differences
      in the predicted concentration of sevoflurane with remifentanil for the insertion of the LMAS
      vs. LMAP.

      Methods: 45 patients American Society of Anesthesiologists (ASA) class I or II aged 20-60
      years undergoing ambulatory elective surgery were randomized to either the LMAS or LMAP. The
      patients were premedicated with midazolam 1 mg iv before surgery. All patients were
      preoxygenated using 100% oxygen with a normal tidal volumen for 3 min. The circuit was primed
      with sevoflurane 5% at a fresh gas flow of 6 L/min for 1 min. Anaesthesia was induced with
      inhaled sevoflurane up to 5% in oxygen via facemask with fresh gas flow at 6 L/min.
      Simultaneously remifentanil at an effect-site of 4 ng/ml was started. Target-controlled
      infusions was used (Alaris PK) for remifentanil administration. After loss of consciousness,
      the inspired concentration of sevoflurane was changed to obtain a predetermined end-tidal
      concentration. A single experienced anaesthetist in the use of supraglottic devices inserted
      the devices according to the manufacturer's recommendations. The LMAs size was chosen
      according to the sex of the patients, size 4 for women and size 5 for men; however for
      patients weighing ≤50 kg a size 3 was inserted. Neuromuscular blocking agents were not given.
      Two nurses, who were blinded to the anaesthetic concentration, classified responses by the
      patient to LMA insertion as either "movement" or "not movement". Assesment was made for jaw
      relaxation and graded with Muzi score. A Muzi score >2 was defined as a failure of insertion.
      The end-tidal (ET) sevoflurane concentration used for each patient was determined using the
      Dixon's up-and-down method. The ratio of the end-tidal to predetermined end-tidal
      concentrations was maintained at 0.9-1.0 for at least 10 minutes to establish equilibration
      before device insertion was attempted. The first patient received a 2.5% sevoflurane
      concentration and the step size of increase/decrease was 0.5%. If the supraglottic device
      (LMAS or LMAP) insertion was successful, sevoflurane concentration for the next patient was
      decrease by 0.5%. If not, sevoflurane concentration was increased by the same amount for the
      next patient. For their comfort, patients experiencing movement received a 1-2 mg/kg bolus
      dose of propofol.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Participant, Investigator)
measure: To compare the the minimum alveolar anesthetic concentration (determined at 1 atmosphere, that prevents movement in 50% of patients to LMAS vs. LMAP insertion) of sevoflurane with simultaneous remifentanil infusion in adult patients.
time frame: The sevoflurane concentration is obtained during the insertion of the LMAS or LMAP in patients, after anesthesia induction
description: To compare the concentration of sevoflurane with concomitant remifentanil infusion required for LMAS insertion vs. the concentration of sevoflurane with concomitant remifentanil infusion required for LMAP insertion.
measure: Blood pressure in mmHg
time frame: Baseline and every 3 minutes until 6 minutes after insertion of the LMAs
description: To compare the evolution of blood pressure during insertion of LMAS group versus LMAP group
measure: Heart rate in bpm,
time frame: Before and after LMAs insertion (every minute until 6 minutes)
description: To compare the evolution of heart rate during insertion of LMAS group versus LMAP group
measure: BIS data, number from 100 (awake) to 40-45 (anesthetic status)
time frame: Before and after LMAs insertion (every minute until 6 minutes)
description: To compare the evolution of BIS values during insertion of LMAS group versus LMAP group
arm group label: Device: laryngeal mask supreme
arm group type: Experimental
description: Determine the Sevoflurane concentration associate with remifentanil for the insertion of the laryngeal mask supreme
arm group label: Device: laryngeal mask proseal
arm group type: Active Comparator
description: Determine the Sevoflurane concentration associate with remifentanil for insertion of the laryngeal mask ProSeal
intervention type: Device
intervention name: laryngeal mask supreme
description: Sevoflurane was administered by facial mask with concomitant remifentanil administration (at an effect-site of 4 ng/ml). The LMAS was inserted according to the manufacturer's recommendations with the patient's head in the neutral position. After equilibrium the LMAS was inserted and secured according to the manufacturer's recommendations, without using muscle relaxants. A single measurement will be obtained from each patient. If the patient reacted with movement, a 1-2 mg/kg dose of Propofol was administered.
arm group label: Device: laryngeal mask supreme
intervention type: Device
intervention name: laryngeal mask proseal
description: Sevoflurane was administered by facial mask with concomitant remifentanil administration (at an effect-site of 4 ng/ml).The LMAP was inserted according to the manufacturer's recommendations with the patient's head in the neutral position. After equilibrium the LMAP was inserted and secured according to the manufacturer's recommendations, without using muscle relaxants. A single measurement will be obtained from each patient. If the patient reacted with movement, a 1-2 mg/kg dose of Propofol was administered.
arm group label: Device: laryngeal mask proseal
criteria: 
gender: All
minimum age: 18 Years
maximum age: 60 Years
healthy volunteers: No
last name: Maite López-Gil, MD, PhD
role: Study Chair
affiliation: Servicio de Anestesiología, Hospital General Universitario Gregorio Marañón
facility: 
country: Spain
responsible party type: Principal Investigator
investigator affiliation: Hospital General Universitario Gregorio Marañon
investigator full name: Matilde Zaballos
investigator title: Clinical professor
sharing ipd: Undecided