<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/NCT01720615</url>
  </required_header>
  <id_info>
    <org_study_id>2001</org_study_id>
    <nct_id>NCT01720615</nct_id>
  </id_info>
  <brief_title>Detection of Consciousness by EEG and Auditory Evoked Potentials</brief_title>
  <official_title>Detection of Consciousness by EEG and Auditory Evoked Potentials</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Technical University of Munich</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Technical University of Munich</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The objective of the present investigation is to analyze EEG and auditory evoked potentials&#xD;
      at the transition from consciousness to unconsciousness and vice versa. A set of&#xD;
      electroencephalographic and auditory evoked potential parameters should be identified that&#xD;
      allows separation of consciousness from unconsciousness (reflected by&#xD;
      responsiveness/unresponsiveness to command). The study is based on data of 80 patients&#xD;
      undergoing general anesthesia with remifentanil and either sevoflurane or propofol.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      During the past years, monitoring of anesthetic effects on the main target of anesthesia, the&#xD;
      brain, has gained increasing attention. Monitoring of the spontaneous electroencephalogram&#xD;
      (EEG) and of auditory evoked potentials (AEP) has been suggested. Even if EEG and AEP reflect&#xD;
      effects of anesthetic drugs, a visual interpretation is not expedient. As a consequence,&#xD;
      several processing methods have been suggested that reduce the electroencephalogram to a&#xD;
      numerical value. In the current study, a set of EEG- and AEP parameters based on different&#xD;
      analysis methods is tested with respect to the parameters ability in separating consciousness&#xD;
      (reflected by responsiveness to command) from unconsciousness at the transition between these&#xD;
      stages. Therefore data of 80 unpremedicated patients undergoing general anesthesia with&#xD;
      remifentanil and either sevoflurane or propofol is used. The study period is from induction&#xD;
      of anesthesia until patients follow command after surgery and includes a reduction of the&#xD;
      hypnotic agent after tracheal intubation until patients follow command. The isolated forearm&#xD;
      technique is applied before muscle relaxants are given to maintain the ability to squeeze&#xD;
      hand to command.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>January 2001</start_date>
  <completion_date type="Actual">April 2003</completion_date>
  <primary_completion_date type="Actual">November 2001</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>Diagnostic</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Changes in EEG- and AEP-parameters during loss- and return of consciousness</measure>
    <time_frame>1 day</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Impact of muscle activity on EEG- and AEP-parameters</measure>
    <time_frame>1 day</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Influence of anesthetics on EEG- and AEP-parameters</measure>
    <time_frame>1 day</time_frame>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">80</enrollment>
  <condition>Anesthesia</condition>
  <condition>Electroencephalography/ Drug Effect</condition>
  <arm_group>
    <arm_group_label>Propofol or Sevoflurane</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>General anesthesia</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Propofol / Remifentanil</intervention_name>
    <description>General anesthesia: Loss of consciousness and standard clinical practice</description>
    <arm_group_label>Propofol or Sevoflurane</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Sevoflurane / Remifentanil</intervention_name>
    <description>General anesthesia: Loss of consciousness and standard clinical practice</description>
    <arm_group_label>Propofol or Sevoflurane</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  American Society of Anesthesiologists (ASA) physical status 1-2&#xD;
&#xD;
          -  Adult patients&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients with contraindications to the study drugs&#xD;
&#xD;
          -  psychiatric or neurologic disease&#xD;
&#xD;
          -  drug abuse or medication known to affect the central nervous system&#xD;
&#xD;
          -  pregnancy&#xD;
&#xD;
          -  indication for rapid sequence induction&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Eberhard F Kochs, MD</last_name>
    <role>Study Chair</role>
    <affiliation>Klinikum rechts der Isar Technische Universität München</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Technische Universität München, Klinikum rechts der Isar, Department of Anesthesiology</name>
      <address>
        <city>Munich</city>
        <state>Bavaria</state>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Germany</country>
  </location_countries>
  <verification_date>October 2012</verification_date>
  <study_first_submitted>October 29, 2012</study_first_submitted>
  <study_first_submitted_qc>October 31, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 2, 2012</study_first_posted>
  <last_update_submitted>October 31, 2012</last_update_submitted>
  <last_update_submitted_qc>October 31, 2012</last_update_submitted_qc>
  <last_update_posted type="Estimate">November 2, 2012</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Technical University of Munich</investigator_affiliation>
    <investigator_full_name>Gerhard Schneider</investigator_full_name>
    <investigator_title>Dr. med.</investigator_title>
  </responsible_party>
  <keyword>EEG</keyword>
  <keyword>AEP</keyword>
  <keyword>Propofol</keyword>
  <keyword>Sevoflurane</keyword>
  <keyword>Remifentanil</keyword>
  <keyword>General anesthesia</keyword>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Remifentanil</mesh_term>
    <mesh_term>Propofol</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/NCT01720615
org study id: 2001
nct id: NCT01720615
lead sponsor: 
has dmc: Yes
The objective of the present investigation is to analyze EEG and auditory evoked potentials
      at the transition from consciousness to unconsciousness and vice versa. A set of
      electroencephalographic and auditory evoked potential parameters should be identified that
      allows separation of consciousness from unconsciousness (reflected by
      responsiveness/unresponsiveness to command). The study is based on data of 80 patients
      undergoing general anesthesia with remifentanil and either sevoflurane or propofol.
During the past years, monitoring of anesthetic effects on the main target of anesthesia, the
      brain, has gained increasing attention. Monitoring of the spontaneous electroencephalogram
      (EEG) and of auditory evoked potentials (AEP) has been suggested. Even if EEG and AEP reflect
      effects of anesthetic drugs, a visual interpretation is not expedient. As a consequence,
      several processing methods have been suggested that reduce the electroencephalogram to a
      numerical value. In the current study, a set of EEG- and AEP parameters based on different
      analysis methods is tested with respect to the parameters ability in separating consciousness
      (reflected by responsiveness to command) from unconsciousness at the transition between these
      stages. Therefore data of 80 unpremedicated patients undergoing general anesthesia with
      remifentanil and either sevoflurane or propofol is used. The study period is from induction
      of anesthesia until patients follow command after surgery and includes a reduction of the
      hypnotic agent after tracheal intubation until patients follow command. The isolated forearm
      technique is applied before muscle relaxants are given to maintain the ability to squeeze
      hand to command.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Diagnostic
masking: None (Open Label)
measure: Changes in EEG- and AEP-parameters during loss- and return of consciousness
time frame: 1 day
measure: Impact of muscle activity on EEG- and AEP-parameters
time frame: 1 day
measure: Influence of anesthetics on EEG- and AEP-parameters
time frame: 1 day
arm group label: Propofol or Sevoflurane
arm group type: No Intervention
description: General anesthesia
intervention type: Drug
intervention name: Propofol / Remifentanil
description: General anesthesia: Loss of consciousness and standard clinical practice
arm group label: Propofol or Sevoflurane
intervention type: Drug
intervention name: Sevoflurane / Remifentanil
description: General anesthesia: Loss of consciousness and standard clinical practice
arm group label: Propofol or Sevoflurane
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
healthy volunteers: No
last name: Eberhard F Kochs, MD
role: Study Chair
affiliation: Klinikum rechts der Isar Technische Universität München
facility: 
country: Germany
responsible party type: Principal Investigator
investigator affiliation: Technical University of Munich
investigator full name: Gerhard Schneider
investigator title: Dr. med.
mesh term: Remifentanil
mesh term: Propofol
mesh term: Sevoflurane