<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/NCT01705743</url>
  </required_header>
  <id_info>
    <org_study_id>TJMZK20120903</org_study_id>
    <nct_id>NCT01705743</nct_id>
  </id_info>
  <brief_title>Minimum Alveolar Concentration of Sevoflurane With Nitrous Oxide Inducing Isoelectric EEG</brief_title>
  <official_title>Minimum Alveolar Concentration of Sevoflurane With 60% Nitrous Oxide Inducing Isoelectric EEG in Mid-aged Adults</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Huazhong University of Science and Technology</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Huazhong University of Science and Technology</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      In order to investigate the effect of a combination effect of sevoflurane and nitrous oxide&#xD;
      on cerebral electrical activity, the investigators determined the MAC of sevoflurane combined&#xD;
      with nitrous oxide inducing isoelectric electroencephalogram (EEG) in 50% of the subjects&#xD;
      (MACie) in middle aged subjects.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Anaesthesia was induced by sevoflurane in oxygen. Cisatracurium 0.15 mg kg-1 was administered&#xD;
      after loss of the lash reﬂex, then ventilated manually until the amplitude of T1 decreased to&#xD;
      0. Intubation was performed and switched to mechanical ventilation with a fresh gas flow of 2&#xD;
      L min-1. Anesthesia was maintained by sevoflurane or sevoflurane+60% nitrous oxide&#xD;
      respectively. The surgical incision was performed at least 30 min after tracheal intubation,&#xD;
      provided that the predetermined end-tidal sevoflurane concentration had been constant for at&#xD;
      least 30 min and that the difference between inspired and end-tidal concentrations was less&#xD;
      than 10%.&#xD;
&#xD;
      Brain electrical activity was measured using Narcotrend Monitor and S/5 Compact Anaesthesia&#xD;
      Monitor, which displayed unprocessed EEG and burst suppression ratio, respectively. The&#xD;
      design of the experiment is referred to the &quot;Dixon up-and-down&quot; method. To avid anaesthesia&#xD;
      awareness, the first subject was designed to receive end-tidal sevoflurane concentration of&#xD;
      2.5 %. The presence or absence of isoelectric EEG (Entropy Module) of the preceding patient&#xD;
      determined the end-tidal concentration of sevoflurane given to the next patient (with an&#xD;
      increment size of 0.2%). The isoelectric EEG was considered as significant when the&#xD;
      isoelectric state last for more than 1 min. The maximal burst suppression rate was recorded&#xD;
      if isoelectric EEG was not reached.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>September 2012</start_date>
  <completion_date type="Actual">October 2013</completion_date>
  <primary_completion_date type="Actual">September 2013</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, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>MACie</measure>
    <time_frame>30min</time_frame>
    <description>Minimal Alveolar Concentration of sevoflurane and NO inducing isoelectric electroencephalogram (EEG) in 50% of the subjects (MACie)</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">76</enrollment>
  <condition>Middle Aged Patients</condition>
  <condition>General Anesthesia</condition>
  <arm_group>
    <arm_group_label>Group 1 Sevoflurane+Nitrous oxide</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Group 2 Sevoflurane</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Sevoflurane+Nitrous oxide</intervention_name>
    <description>60% nitrous oxide +40% oxygen+ Sevoflurane</description>
    <arm_group_label>Group 1 Sevoflurane+Nitrous oxide</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Sevoflurane</intervention_name>
    <description>100% oxygen+ Sevoflurane</description>
    <arm_group_label>Group 2 Sevoflurane</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  between 45 to 64 years old&#xD;
&#xD;
          -  ASA physical status class 1 or 2&#xD;
&#xD;
          -  elective abdominal surgery&#xD;
&#xD;
          -  Informed Consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  history of 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;
&#xD;
          -  others judged inappropriate as subjects for the study by the Study Chair&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>45 Years</minimum_age>
    <maximum_age>64 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>February 2014</verification_date>
  <study_first_submitted>October 10, 2012</study_first_submitted>
  <study_first_submitted_qc>October 11, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 12, 2012</study_first_posted>
  <last_update_submitted>February 3, 2014</last_update_submitted>
  <last_update_submitted_qc>February 3, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">February 4, 2014</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>Associate Professor</investigator_title>
  </responsible_party>
  <keyword>anaesthesia</keyword>
  <keyword>middle aged</keyword>
  <keyword>minimal alveolar concentration</keyword>
  <keyword>sevoflurane</keyword>
  <keyword>nitrous oxide</keyword>
  <keyword>isoelectric EEG</keyword>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Nitrous Oxide</mesh_term>
    <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/NCT01705743
org study id: TJMZK20120903
nct id: NCT01705743
lead sponsor: 
has dmc: Yes
In order to investigate the effect of a combination effect of sevoflurane and nitrous oxide
      on cerebral electrical activity, the investigators determined the MAC of sevoflurane combined
      with nitrous oxide inducing isoelectric electroencephalogram (EEG) in 50% of the subjects
      (MACie) in middle aged subjects.
Anaesthesia was induced by sevoflurane in oxygen. Cisatracurium 0.15 mg 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 of 2
      L min-1. Anesthesia was maintained by sevoflurane or sevoflurane+60% nitrous oxide
      respectively. The surgical incision was performed at least 30 min after tracheal intubation,
      provided that the predetermined end-tidal sevoflurane concentration had been constant for at
      least 30 min and that the difference between inspired and end-tidal concentrations was less
      than 10%.

      Brain electrical activity was measured using Narcotrend Monitor and S/5 Compact Anaesthesia
      Monitor, which displayed unprocessed EEG and burst suppression ratio, respectively. The
      design of the experiment is referred to the "Dixon up-and-down" method. To avid anaesthesia
      awareness, the first subject was designed to receive end-tidal sevoflurane concentration of
      2.5 %. The presence or absence of isoelectric EEG (Entropy Module) of the preceding patient
      determined the end-tidal concentration of sevoflurane given to the next patient (with an
      increment size of 0.2%). The isoelectric EEG was considered as significant when the
      isoelectric state last for more than 1 min. The maximal burst suppression rate was recorded
      if isoelectric EEG was not reached.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Participant, Outcomes Assessor)
measure: MACie
time frame: 30min
description: Minimal Alveolar Concentration of sevoflurane and NO inducing isoelectric electroencephalogram (EEG) in 50% of the subjects (MACie)
arm group label: Group 1 Sevoflurane+Nitrous oxide
arm group type: Active Comparator
arm group label: Group 2 Sevoflurane
arm group type: Active Comparator
intervention type: Drug
intervention name: Sevoflurane+Nitrous oxide
description: 60% nitrous oxide +40% oxygen+ Sevoflurane
arm group label: Group 1 Sevoflurane+Nitrous oxide
intervention type: Drug
intervention name: Sevoflurane
description: 100% oxygen+ Sevoflurane
arm group label: Group 2 Sevoflurane
criteria: 
gender: All
minimum age: 45 Years
maximum age: 64 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: Associate Professor
mesh term: Nitrous Oxide
mesh term: Sevoflurane