<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/NCT02202720</url>
  </required_header>
  <id_info>
    <org_study_id>CHU-0200</org_study_id>
    <secondary_id>2014-000759-10</secondary_id>
    <nct_id>NCT02202720</nct_id>
  </id_info>
  <brief_title>Evaluation of Richmond Agitation Sedation Scale According to Alveolar Concentration of Sevoflurane During a Sedation With Sevoflurane in ICU Patients</brief_title>
  <acronym>SEVORASS</acronym>
  <official_title>Evaluation of Richmond Agitation Sedation Scale According to Alveolar Concentration of Sevoflurane During a Sedation With Sevoflurane in ICU Patients</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University Hospital, Clermont-Ferrand</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University Hospital, Clermont-Ferrand</source>
  <brief_summary>
    <textblock>
      Describe the Richmond Agitation Sedation Scale (RASS) values corresponding to the values of&#xD;
      Minimum alveolar concentration of sevoflurane during sedation of patients in ICU&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Prospective clinical study in ICU with sedated ventilated patients with sevoflurane using the&#xD;
      Mirus® system. Pharmacological study of the concentration-effect relationship by&#xD;
      administration at increasing and decreasing concentrations.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>August 2014</start_date>
  <completion_date type="Actual">November 2014</completion_date>
  <primary_completion_date type="Actual">November 2014</primary_completion_date>
  <phase>Phase 2</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Description of the RASS score</measure>
    <time_frame>at day 1</time_frame>
    <description>Describe the RASS score corresponding to the values of sevoflurane MAC during sedation of patients in ICU : RASS score determined at the middle of each level of 30 minutes, each level correspond to determined sevoflurane MAC with ascending MAC ranging from 0 to 0.8 and then descending MAC from 0.8 to 0.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>determination of the associated hemodynamic and respiratory parameters</measure>
    <time_frame>at day 1</time_frame>
    <description>Determine the associated hemodynamic and respiratory parameters, bispectral index and analgesia-nociception index for each level of sevoflurane MAC (monitored at the middle of each level of 30 minutes).</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">30</enrollment>
  <condition>Requiring Sedation by Sevoflurane in ICU</condition>
  <condition>Adult Patients</condition>
  <condition>Patients Covered by French Health Care System</condition>
  <condition>Patients Who Have Given Their Consent</condition>
  <arm_group>
    <arm_group_label>sevoflurane</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Sevoflurane</intervention_name>
    <description>Short term sedation with sevoflurane in ICU</description>
    <arm_group_label>sevoflurane</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Requiring sedation by sevoflurane in ICU&#xD;
&#xD;
          -  Adult patients&#xD;
&#xD;
          -  Patients covered by french health care system&#xD;
&#xD;
          -  Patients who have given their consent or his family&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Pregnant or lactating women&#xD;
&#xD;
          -  Sevoflurane anaphylaxia&#xD;
&#xD;
          -  Known or suspected risk of malignant hyperthermia&#xD;
&#xD;
          -  Refusal Protocol&#xD;
&#xD;
          -  Brain-damaged patients&#xD;
&#xD;
          -  Hemodynamic conditions not compatible with the use of sevoflurane&#xD;
&#xD;
          -  ARDS patients&#xD;
&#xD;
          -  Minor patients&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Sébastien PERBET</last_name>
    <role>Principal Investigator</role>
    <affiliation>University Hospital, Clermont-Ferrand</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>CHU Clermont-Ferrand</name>
      <address>
        <city>Clermont-Ferrand</city>
        <zip>63003</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>November 2014</verification_date>
  <study_first_submitted>July 25, 2014</study_first_submitted>
  <study_first_submitted_qc>July 28, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 29, 2014</study_first_posted>
  <last_update_submitted>November 25, 2014</last_update_submitted>
  <last_update_submitted_qc>November 25, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">November 26, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Sevoflurane</keyword>
  <keyword>RASS score</keyword>
  <keyword>Sedation</keyword>
  <keyword>Minimal alveolar concentration (MAC)</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Psychomotor Agitation</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Sevoflurane</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/NCT02202720
org study id: CHU-0200
secondary id: 2014-000759-10
nct id: NCT02202720
lead sponsor: 
Describe the Richmond Agitation Sedation Scale (RASS) values corresponding to the values of
      Minimum alveolar concentration of sevoflurane during sedation of patients in ICU
Prospective clinical study in ICU with sedated ventilated patients with sevoflurane using the
      Mirus® system. Pharmacological study of the concentration-effect relationship by
      administration at increasing and decreasing concentrations.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Description of the RASS score
time frame: at day 1
description: Describe the RASS score corresponding to the values of sevoflurane MAC during sedation of patients in ICU : RASS score determined at the middle of each level of 30 minutes, each level correspond to determined sevoflurane MAC with ascending MAC ranging from 0 to 0.8 and then descending MAC from 0.8 to 0.
measure: determination of the associated hemodynamic and respiratory parameters
time frame: at day 1
description: Determine the associated hemodynamic and respiratory parameters, bispectral index and analgesia-nociception index for each level of sevoflurane MAC (monitored at the middle of each level of 30 minutes).
arm group label: sevoflurane
arm group type: Experimental
intervention type: Drug
intervention name: Sevoflurane
description: Short term sedation with sevoflurane in ICU
arm group label: sevoflurane
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Sébastien PERBET
role: Principal Investigator
affiliation: University Hospital, Clermont-Ferrand
facility: 
country: France
responsible party type: Sponsor
mesh term: Psychomotor Agitation
mesh term: Sevoflurane