<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/NCT01662622</url>
  </required_header>
  <id_info>
    <org_study_id>TJMZK20120301</org_study_id>
    <nct_id>NCT01662622</nct_id>
  </id_info>
  <brief_title>Minimal Alveolar Concentration of Sevoflurane Inducing Isoelectric Electroencephalogram</brief_title>
  <official_title>Minimal Alveolar Concentration of Sevoflurane Inducing Isoelectric Electroencephalogram</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Huazhong University of Science and Technology</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Ministry of Health, China</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>National Natural Science Foundation of China</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Huazhong University of Science and Technology</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Sevoflurane can abolish movement or adrenergic response to noxious stimulus. In order to&#xD;
      investigate the effect of sevoflurane on cerebral electrical activity, we determined the MAC&#xD;
      of sevoflurane inducing isoelectric electroencephalogram (EEG) in 50% of the subjects (MACie)&#xD;
      in middle aged subjects.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Patients received sevoflurane for anesthesia induction and maintenance at preselected&#xD;
      concentrations according to an 'up and down' design, with 0.2% as a stepsize. General&#xD;
      anesthesia was induced and maintained with sevoflurane, tracheal intubation was facilitated&#xD;
      with cisatracurium. After a steady-state period of 30min without surgical stimulation, the&#xD;
      state of isoelectric EEG was considered as significant when a burst suppression ratio of 100%&#xD;
      last for more than 1 min. The haemodynamic responses to skin incision and the vasopressor&#xD;
      requirement to maintain cardiovascular system were also analysed according to the EEG state.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>March 2012</start_date>
  <completion_date type="Actual">July 2012</completion_date>
  <primary_completion_date type="Actual">May 2012</primary_completion_date>
  <phase>Phase 4</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>MACie</measure>
    <time_frame>30min</time_frame>
    <description>Minimal Alveolar Concentration of sevoflurane inducing isoelectric electroencephalogram (EEG) in 50% of the subjects (MACie)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>MACbs</measure>
    <time_frame>30 min</time_frame>
    <description>Minimal Alveolar Concentration of sevoflurane inducing inducing burst suppression EEG (MACbs) in middle aged adults.</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Hemodynamic parameters</measure>
    <time_frame>3 min</time_frame>
    <description>Hemodynamic parameters 2 min before and 3 min after skin incision</description>
  </other_outcome>
  <other_outcome>
    <measure>Use of phenylephrine</measure>
    <time_frame>30 min</time_frame>
    <description>Use of phenylephrine during induction and maintenance of anesthesia with sevoflurane.</description>
  </other_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">31</enrollment>
  <condition>Middle Aged Patients</condition>
  <condition>Sevoflurane</condition>
  <condition>General Anesthesia</condition>
  <arm_group>
    <arm_group_label>Sevoflurane</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Anaesthesia was induced by 8% sevoflurane. Cisatracurium 0.15mg kg-1 was administered after loss of the lash reﬂex, then ventilated manually until the amplitude of T1 decreased to 0. Intubation was performed and switched to mechanical ventilation with a fresh gas flow 2L min-1. Gas concentrations were analysed using a gas analyser.The end-tidal concentration of carbon dioxide was maintained at 4.7kPa; an esophageal temperature probe was inserted and a warming unit was used if necessary to maintain normothermia (35.5°-38.5°). The surgical incision was performed at least 30min after tracheal intubation. When arterial blood pressure (MAP) decrease exceeding 20% of baseline values. Phenylephrine 0.1mg was administered intravenously if necessary to maintained MAP and recorded.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Sevoflurane</intervention_name>
    <description>The design of experiment is referred to the &quot;Dixon up-and-down&quot; method. The first subject was designed to receive end-tidal sevoflurane concentration of 1.7%. For each subject, 30 min interval time was given. The isoelectric EEG was considered as significant when the isoelectric state last for more than 1min. The maximal burst suppression rate was recorded if isoelectric EEG was not reached. Heart rate and MAP, were recorded 2 and 1min before and 3 min after skin incision. Adrenergic reflexes positive cases were counted.</description>
    <arm_group_label>Sevoflurane</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  45-65yr&#xD;
&#xD;
          -  upper abdominal surgery in general anaesthesia&#xD;
&#xD;
          -  ASA physical status classification of I or II&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  neurological disease&#xD;
&#xD;
          -  received central nervous system-active drugs&#xD;
&#xD;
          -  cardiac ejection fraction less than 40%&#xD;
&#xD;
          -  history of difficult intubation or anticipated difficult intubation&#xD;
&#xD;
          -  daily alcohol consumption&#xD;
&#xD;
          -  obesity, defined as a body-mass index of more than 30&#xD;
&#xD;
          -  without informed consent&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>45 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Yuke Tian, MD.</last_name>
    <role>Study Chair</role>
    <affiliation>Department of Anaesthesiology, Tongji Hospital of Tongji Medical College, Huazhong University of Science and Technology</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Department of Anaesthesiology, Tongji Hospital of Tongji Medical College, Huazhong University of Science and Technology</name>
      <address>
        <city>Wuhan</city>
        <state>Hubei</state>
        <zip>430030</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>August 2012</verification_date>
  <study_first_submitted>August 8, 2012</study_first_submitted>
  <study_first_submitted_qc>August 9, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 10, 2012</study_first_posted>
  <last_update_submitted>August 12, 2012</last_update_submitted>
  <last_update_submitted_qc>August 12, 2012</last_update_submitted_qc>
  <last_update_posted type="Estimate">August 14, 2012</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Huazhong University of Science and Technology</investigator_affiliation>
    <investigator_full_name>Wei Mei</investigator_full_name>
    <investigator_title>AssociateProfessor</investigator_title>
  </responsible_party>
  <keyword>anaesthesia</keyword>
  <keyword>middle aged</keyword>
  <keyword>minimal alveolar concentration</keyword>
  <keyword>sevoflurane</keyword>
  <keyword>isoelectric EEG</keyword>
  <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/NCT01662622
org study id: TJMZK20120301
nct id: NCT01662622
lead sponsor: 
collaborator: 
collaborator: 
has dmc: Yes
Sevoflurane can abolish movement or adrenergic response to noxious stimulus. In order to
      investigate the effect of sevoflurane on cerebral electrical activity, we determined the MAC
      of sevoflurane inducing isoelectric electroencephalogram (EEG) in 50% of the subjects (MACie)
      in middle aged subjects.
Patients received sevoflurane for anesthesia induction and maintenance at preselected
      concentrations according to an 'up and down' design, with 0.2% as a stepsize. General
      anesthesia was induced and maintained with sevoflurane, tracheal intubation was facilitated
      with cisatracurium. After a steady-state period of 30min without surgical stimulation, the
      state of isoelectric EEG was considered as significant when a burst suppression ratio of 100%
      last for more than 1 min. The haemodynamic responses to skin incision and the vasopressor
      requirement to maintain cardiovascular system were also analysed according to the EEG state.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: MACie
time frame: 30min
description: Minimal Alveolar Concentration of sevoflurane inducing isoelectric electroencephalogram (EEG) in 50% of the subjects (MACie)
measure: MACbs
time frame: 30 min
description: Minimal Alveolar Concentration of sevoflurane inducing inducing burst suppression EEG (MACbs) in middle aged adults.
measure: Hemodynamic parameters
time frame: 3 min
description: Hemodynamic parameters 2 min before and 3 min after skin incision
measure: Use of phenylephrine
time frame: 30 min
description: Use of phenylephrine during induction and maintenance of anesthesia with sevoflurane.
arm group label: Sevoflurane
arm group type: Experimental
description: Anaesthesia was induced by 8% sevoflurane. Cisatracurium 0.15mg kg-1 was administered after loss of the lash reﬂex, then ventilated manually until the amplitude of T1 decreased to 0. Intubation was performed and switched to mechanical ventilation with a fresh gas flow 2L min-1. Gas concentrations were analysed using a gas analyser.The end-tidal concentration of carbon dioxide was maintained at 4.7kPa; an esophageal temperature probe was inserted and a warming unit was used if necessary to maintain normothermia (35.5°-38.5°). The surgical incision was performed at least 30min after tracheal intubation. When arterial blood pressure (MAP) decrease exceeding 20% of baseline values. Phenylephrine 0.1mg was administered intravenously if necessary to maintained MAP and recorded.
intervention type: Drug
intervention name: Sevoflurane
description: The design of experiment is referred to the "Dixon up-and-down" method. The first subject was designed to receive end-tidal sevoflurane concentration of 1.7%. For each subject, 30 min interval time was given. The isoelectric EEG was considered as significant when the isoelectric state last for more than 1min. The maximal burst suppression rate was recorded if isoelectric EEG was not reached. Heart rate and MAP, were recorded 2 and 1min before and 3 min after skin incision. Adrenergic reflexes positive cases were counted.
arm group label: Sevoflurane
criteria: 
gender: All
minimum age: 45 Years
maximum age: 65 Years
healthy volunteers: No
last name: Yuke Tian, MD.
role: Study Chair
affiliation: Department of Anaesthesiology, Tongji Hospital of Tongji Medical College, Huazhong University of Science and Technology
facility: 
country: China
responsible party type: Principal Investigator
investigator affiliation: Huazhong University of Science and Technology
investigator full name: Wei Mei
investigator title: AssociateProfessor
mesh term: Sevoflurane