<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/NCT02245789</url>
  </required_header>
  <id_info>
    <org_study_id>2013/43</org_study_id>
    <secondary_id>2013-A01308-37</secondary_id>
    <nct_id>NCT02245789</nct_id>
  </id_info>
  <brief_title>Does the Use of a Videolaryngoscope Modifies Anesthetic Induction ?</brief_title>
  <acronym>MGM-PicRemi</acronym>
  <official_title>Does the Use of a Videolaryngoscope Modifies Anesthetic Induction ?</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Hopital Foch</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Hopital Foch</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Videolaryngoscopes become widely used. The aim of this study is to compare anesthetic&#xD;
      induction when patients are tracheally intubated using a MacGraph Mac videolaryngoscope or a&#xD;
      conventional MacIntosh laryngoscope.&#xD;
&#xD;
      Tracheal intubation induces a nociceptive stimulation. Hypothesis is that the use of a&#xD;
      videolaryngoscope induces a less pronounced nociceptive stimulation and, consequently, that&#xD;
      it modifies the anesthetic drugs requirement. .&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      All patients will received a standardized anesthetic procedure : combined closed-loop&#xD;
      anesthesia system using bispectral index as control variable and two&#xD;
      proportional-differential control algorithms, a propofol and a remifentanil target-controlled&#xD;
      infusion system. The effectiveness of such a closed-loop anesthesia system has been&#xD;
      demonstrated in a prospective, randomized study.&#xD;
&#xD;
      Patients will be randomized in two groups : intubation using a conventional MacIntosh&#xD;
      laryngoscope or intubation using a videolaryngoscope.&#xD;
&#xD;
      If our hypothesis is confirmed, the required concentration of remifentanil, an opioid agent,&#xD;
      will be reduced in the group using a videolaryngoscope.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>September 2014</start_date>
  <completion_date type="Actual">February 2015</completion_date>
  <primary_completion_date type="Actual">February 2015</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>Treatment</primary_purpose>
    <masking>Single (Participant)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Required dose of opioid to counteract nociceptive stimulation</measure>
    <time_frame>1 hour</time_frame>
    <description>Tracheal intubation induces a nociceptive stimulation. Hypothesis is that the use of a videolaryngoscope induces a less pronounced nociceptive stimulation and, consequently, that the required maximal concentration of remifentanil is lower than when a standard laryngoscope is used.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Characteristics of anesthesia</measure>
    <time_frame>one hour</time_frame>
    <description>Peak concentration of propofol</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Characteristics of anesthesia</measure>
    <time_frame>one hour</time_frame>
    <description>doses of propofol and of remifentanil (from beginning of the induction to 5 minutes after tracheal intubation)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Characteristics of anesthesia</measure>
    <time_frame>one hour</time_frame>
    <description>values of bispectral index (from beginning of the induction to 5 minutes after tracheal intubation)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Characteristics of tracheal intubation</measure>
    <time_frame>one hour</time_frame>
    <description>time to obtain the first capnogram</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Characteristics of tracheal intubation</measure>
    <time_frame>one hour</time_frame>
    <description>visualization of the glottis (score of Cormak and Lehane modified by Yentis, POGO score</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Characteristics of tracheal intubation</measure>
    <time_frame>one hour</time_frame>
    <description>use of alternative techniques for intubation</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Characteristics of tracheal intubation</measure>
    <time_frame>one hour</time_frame>
    <description>esophageal intubation</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Characteristics of tracheal intubation</measure>
    <time_frame>one hour</time_frame>
    <description>incidence of arterial oxygen desaturation (SpO2 &lt;92%)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Characteristics of tracheal intubation</measure>
    <time_frame>one hour</time_frame>
    <description>hemodynamic effects of induction and tracheal intubation</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Complications of intubation</measure>
    <time_frame>one day</time_frame>
    <description>Throat pain and hoarseness</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Ergonomic evaluation of the device</measure>
    <time_frame>one hour</time_frame>
    <description>questionnaire Qusi</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">50</enrollment>
  <condition>Tracheal Intubation</condition>
  <arm_group>
    <arm_group_label>Macintosh laryngoscope</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Tracheal intubation will be performed using a Macintosh laryngoscope. All patients will received propofol and remifentanil anesthesia.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>McGrath Mac videolaryngoscope</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Tracheal intubation will be performed using a McGrath Mac videolaryngoscope. All patients will received propofol and remifentanil anesthesia.</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Tracheal intubation</intervention_name>
    <description>Tracheal intubation will be performed using a Macintosh laryngoscope or a McGrath Mac videolaryngoscope</description>
    <arm_group_label>Macintosh laryngoscope</arm_group_label>
    <arm_group_label>McGrath Mac videolaryngoscope</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Propofol and remifentanil anesthesia</intervention_name>
    <description>The standardized anesthetic procedure used a closed-loop anesthesia system with bispectral index as control variable and with two proportional-differential control algorithms, one for propofol target-controlled infusion system and one for remifentanil target-controlled infusion system.</description>
    <arm_group_label>Macintosh laryngoscope</arm_group_label>
    <arm_group_label>McGrath Mac videolaryngoscope</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  patient scheduled for a general anesthesia with orotracheal intubation&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  predictable risk of difficult mask ventilation or of difficult tracheal intubation&#xD;
&#xD;
          -  necessity of a rapid sequence induction&#xD;
&#xD;
          -  contra-indication to the use of the automated administration of propofol and of&#xD;
             remifentanil&#xD;
&#xD;
          -  contra-indication to the use of atracurium&#xD;
&#xD;
          -  Otolaryngology, thoracic surgery, or intracranial surgery&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Michel Chandon, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Hopital Foch</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Institut Hospitalier Franco-Britannique</name>
      <address>
        <city>Levallois-Perret</city>
        <state>Hauts de Seine</state>
        <zip>92300</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hopital Foch</name>
      <address>
        <city>Suresnes</city>
        <state>Hauts de Seine</state>
        <zip>92151</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <reference>
    <citation>Liu N, Chazot T, Hamada S, Landais A, Boichut N, Dussaussoy C, Trillat B, Beydon L, Samain E, Sessler DI, Fischler M. Closed-loop coadministration of propofol and remifentanil guided by bispectral index: a randomized multicenter study. Anesth Analg. 2011 Mar;112(3):546-57. doi: 10.1213/ANE.0b013e318205680b. Epub 2011 Jan 13.</citation>
    <PMID>21233500</PMID>
  </reference>
  <verification_date>October 2016</verification_date>
  <study_first_submitted>September 4, 2014</study_first_submitted>
  <study_first_submitted_qc>September 19, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 22, 2014</study_first_posted>
  <last_update_submitted>October 28, 2016</last_update_submitted>
  <last_update_submitted_qc>October 28, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">October 31, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Remifentanil</mesh_term>
    <mesh_term>Propofol</mesh_term>
  </intervention_browse>
  <!-- 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/NCT02245789
org study id: 2013/43
secondary id: 2013-A01308-37
nct id: NCT02245789
lead sponsor: 
has dmc: No
Videolaryngoscopes become widely used. The aim of this study is to compare anesthetic
      induction when patients are tracheally intubated using a MacGraph Mac videolaryngoscope or a
      conventional MacIntosh laryngoscope.

      Tracheal intubation induces a nociceptive stimulation. Hypothesis is that the use of a
      videolaryngoscope induces a less pronounced nociceptive stimulation and, consequently, that
      it modifies the anesthetic drugs requirement. .
All patients will received a standardized anesthetic procedure : combined closed-loop
      anesthesia system using bispectral index as control variable and two
      proportional-differential control algorithms, a propofol and a remifentanil target-controlled
      infusion system. The effectiveness of such a closed-loop anesthesia system has been
      demonstrated in a prospective, randomized study.

      Patients will be randomized in two groups : intubation using a conventional MacIntosh
      laryngoscope or intubation using a videolaryngoscope.

      If our hypothesis is confirmed, the required concentration of remifentanil, an opioid agent,
      will be reduced in the group using a videolaryngoscope.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Participant)
measure: Required dose of opioid to counteract nociceptive stimulation
time frame: 1 hour
description: Tracheal intubation induces a nociceptive stimulation. Hypothesis is that the use of a videolaryngoscope induces a less pronounced nociceptive stimulation and, consequently, that the required maximal concentration of remifentanil is lower than when a standard laryngoscope is used.
measure: Characteristics of anesthesia
time frame: one hour
description: Peak concentration of propofol
measure: Characteristics of anesthesia
time frame: one hour
description: doses of propofol and of remifentanil (from beginning of the induction to 5 minutes after tracheal intubation)
measure: Characteristics of anesthesia
time frame: one hour
description: values of bispectral index (from beginning of the induction to 5 minutes after tracheal intubation)
measure: Characteristics of tracheal intubation
time frame: one hour
description: time to obtain the first capnogram
measure: Characteristics of tracheal intubation
time frame: one hour
description: visualization of the glottis (score of Cormak and Lehane modified by Yentis, POGO score
measure: Characteristics of tracheal intubation
time frame: one hour
description: use of alternative techniques for intubation
measure: Characteristics of tracheal intubation
time frame: one hour
description: esophageal intubation
measure: Characteristics of tracheal intubation
time frame: one hour
description: incidence of arterial oxygen desaturation (SpO2 <92%)
measure: Characteristics of tracheal intubation
time frame: one hour
description: hemodynamic effects of induction and tracheal intubation
measure: Complications of intubation
time frame: one day
description: Throat pain and hoarseness
measure: Ergonomic evaluation of the device
time frame: one hour
description: questionnaire Qusi
arm group label: Macintosh laryngoscope
arm group type: Active Comparator
description: Tracheal intubation will be performed using a Macintosh laryngoscope. All patients will received propofol and remifentanil anesthesia.
arm group label: McGrath Mac videolaryngoscope
arm group type: Experimental
description: Tracheal intubation will be performed using a McGrath Mac videolaryngoscope. All patients will received propofol and remifentanil anesthesia.
intervention type: Procedure
intervention name: Tracheal intubation
description: Tracheal intubation will be performed using a Macintosh laryngoscope or a McGrath Mac videolaryngoscope
arm group label: Macintosh laryngoscope
arm group label: McGrath Mac videolaryngoscope
intervention type: Drug
intervention name: Propofol and remifentanil anesthesia
description: The standardized anesthetic procedure used a closed-loop anesthesia system with bispectral index as control variable and with two proportional-differential control algorithms, one for propofol target-controlled infusion system and one for remifentanil target-controlled infusion system.
arm group label: Macintosh laryngoscope
arm group label: McGrath Mac videolaryngoscope
criteria: 
gender: All
minimum age: 18 Years
maximum age: 80 Years
healthy volunteers: No
last name: Michel Chandon, MD
role: Principal Investigator
affiliation: Hopital Foch
facility: 
facility: 
country: France
citation: Liu N, Chazot T, Hamada S, Landais A, Boichut N, Dussaussoy C, Trillat B, Beydon L, Samain E, Sessler DI, Fischler M. Closed-loop coadministration of propofol and remifentanil guided by bispectral index: a randomized multicenter study. Anesth Analg. 2011 Mar;112(3):546-57. doi: 10.1213/ANE.0b013e318205680b. Epub 2011 Jan 13.
PMID: 21233500
responsible party type: Sponsor
mesh term: Remifentanil
mesh term: Propofol