<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/NCT01694901</url>
  </required_header>
  <id_info>
    <org_study_id>Smart-Outcome</org_study_id>
    <nct_id>NCT01694901</nct_id>
  </id_info>
  <brief_title>Optimization of the Anesthetic Regimen Using the SmartPilot® System and Influence on Different Outcome Parameters - a Pilot Study.</brief_title>
  <official_title>Optimization of the Anesthetic Regimen Using the SmartPilot® System and Influence on Different Outcome Parameters - a Pilot Study. A Single- Center Prospective Randomized Controlled Pilot Study.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Claudia Spies</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Charite University, Berlin, Germany</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study investigates whether general anesthesia using a Pharmacokinetic/Pharmacodynamic&#xD;
      (PK/PD) -model-based index indicating the compound effect of different anesthetics leads to&#xD;
      optimized outcome compared to manually controlled clinical anesthesia and computerized&#xD;
      Electroencephalogram (EEG).&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">November 12, 2013</start_date>
  <completion_date type="Actual">July 14, 2017</completion_date>
  <primary_completion_date type="Actual">March 1, 2016</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Postoperative delirium</measure>
    <time_frame>In the 8-day postoperative sample period</time_frame>
    <description>Nursing Delirium Csreening Scale (Nu-DESC), Confusion Assessment Method for the Intensive Care Unit (CAM-ICU), Diagnostic and Statistical Manual of Mental Disorders (DSM-IV-R), International Classification of Diseases (ICD-10)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Postoperative cognitive deficit</measure>
    <time_frame>In the 8-day postoperative sample period</time_frame>
    <description>Test Battery: Verbal Learning Test, Stroop Colour Word Test, Letter Digit Substitution Test, Concept Shifting Test</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Wake-up time</measure>
    <time_frame>In the 8-day postoperative sample period</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Duration of treatment in the recovery room</measure>
    <time_frame>In the 8-day postoperative sample period</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Correlation of EEG-based depth of anesthesia (BIS®) with PK/PD-based Noxious Stimulus Response Index (NSRI) of the SmartPilot® system.</measure>
    <time_frame>In the 8-day postoperative sample period</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Correlation of Bispectral index (BIS®)- and NSRI readings with Near infrared spectroscopy (NIRS) - readings as parameters of regional cerebral oxygen saturation.</measure>
    <time_frame>In the 8-day postoperative sample period</time_frame>
  </secondary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Actual">150</enrollment>
  <condition>Postoperative Cognitive Disturbances</condition>
  <arm_group>
    <arm_group_label>SmartPilot® system</arm_group_label>
    <description>50 patients scheduled for elective surgery (general/abdominal surgery; traumatological/orthopedic surgery, gynecology, urology) in general anesthesia using the SmartPilot® system</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Standard arm</arm_group_label>
    <description>50 patients scheduled for elective surgery (general/abdominal surgery; traumatological/orthopedic surgery, gynecology, urology) in general anesthesia according to the standard operating procedures of the department, i.e. manually controlled clinical anesthesia and EEG-derived parameters of anesthetic depth</description>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        Male/female patients scheduled for elective surgery (general/abdominal surgery;&#xD;
        traumatological/orthopedic surgery, gynecology, urology) in general anesthesia at Charité -&#xD;
        Universitaetsmedizin Berlin, Campus Mitte and Campus Virchow-Klinikum&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Offered patient information and written informed consent&#xD;
&#xD;
          -  Male/female patients with intended ratio of 1:1&#xD;
&#xD;
          -  patients aged greater than or equal to 60 years&#xD;
&#xD;
          -  scheduled duration of surgery longer than or equal to 60 minutes&#xD;
&#xD;
          -  elective surgery (general/abdominal surgery, traumatological/orthopedic surgery,&#xD;
             gynecology, urology) in general anesthesia&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Persons without the capacity to consent&#xD;
&#xD;
          -  Unability of German language use&#xD;
&#xD;
          -  Lacking willingness to save and hand out data within the study&#xD;
&#xD;
          -  Participation in another study according to the German Medicinal Products Act within&#xD;
             30 days before participation in the Smart-Outcome study&#xD;
&#xD;
          -  Accommodation in an institution due to an official or judicial order&#xD;
&#xD;
          -  (Unclear) history of alcohol or substances disabuse&#xD;
&#xD;
          -  Member of staff of the Charité&#xD;
&#xD;
          -  Neurological or psychiatric disease&#xD;
&#xD;
          -  American Society of Anaesthesiologists (ASA) classification greater than or equal to&#xD;
             class IV&#xD;
&#xD;
          -  Moribund patients&#xD;
&#xD;
        Due to the underlying PKPD models of the SmartPilot® system, patient with the following&#xD;
        characteristics cannot be anesthetized using SmartPilot®:&#xD;
&#xD;
          -  Height &lt; 150 or &gt; 200 cm, respectively&#xD;
&#xD;
          -  Weight &lt; 40 or &gt; 140 kg, respectively&#xD;
&#xD;
          -  Body Mass Index &gt; 30&#xD;
&#xD;
          -  Age &lt; 18 or &gt; 90 years of age, respectively&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>90 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Spies Claudia, MD, Prof.</last_name>
    <role>Study Director</role>
    <affiliation>Charite University, Berlin, Germany</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Department of Anesthesiology and Intensive Care Medicine, Campus Virchow Klinikum, Charité - Universitätsmedizin</name>
      <address>
        <city>Berlin</city>
        <zip>13353</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Germany</country>
  </location_countries>
  <verification_date>June 2019</verification_date>
  <study_first_submitted>September 25, 2012</study_first_submitted>
  <study_first_submitted_qc>September 25, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 27, 2012</study_first_posted>
  <last_update_submitted>June 27, 2019</last_update_submitted>
  <last_update_submitted_qc>June 27, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">June 28, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>Charite University, Berlin, Germany</investigator_affiliation>
    <investigator_full_name>Claudia Spies</investigator_full_name>
    <investigator_title>Prof. Dr. C. Claudia</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Cognitive Dysfunction</mesh_term>
  </condition_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/NCT01694901
org study id: Smart-Outcome
nct id: NCT01694901
lead sponsor: 
has dmc: No
This study investigates whether general anesthesia using a Pharmacokinetic/Pharmacodynamic
      (PK/PD) -model-based index indicating the compound effect of different anesthetics leads to
      optimized outcome compared to manually controlled clinical anesthesia and computerized
      Electroencephalogram (EEG).
observational model: Cohort
time perspective: Prospective
measure: Postoperative delirium
time frame: In the 8-day postoperative sample period
description: Nursing Delirium Csreening Scale (Nu-DESC), Confusion Assessment Method for the Intensive Care Unit (CAM-ICU), Diagnostic and Statistical Manual of Mental Disorders (DSM-IV-R), International Classification of Diseases (ICD-10)
measure: Postoperative cognitive deficit
time frame: In the 8-day postoperative sample period
description: Test Battery: Verbal Learning Test, Stroop Colour Word Test, Letter Digit Substitution Test, Concept Shifting Test
measure: Wake-up time
time frame: In the 8-day postoperative sample period
measure: Duration of treatment in the recovery room
time frame: In the 8-day postoperative sample period
measure: Correlation of EEG-based depth of anesthesia (BIS®) with PK/PD-based Noxious Stimulus Response Index (NSRI) of the SmartPilot® system.
time frame: In the 8-day postoperative sample period
measure: Correlation of Bispectral index (BIS®)- and NSRI readings with Near infrared spectroscopy (NIRS) - readings as parameters of regional cerebral oxygen saturation.
time frame: In the 8-day postoperative sample period
arm group label: SmartPilot® system
description: 50 patients scheduled for elective surgery (general/abdominal surgery; traumatological/orthopedic surgery, gynecology, urology) in general anesthesia using the SmartPilot® system
arm group label: Standard arm
description: 50 patients scheduled for elective surgery (general/abdominal surgery; traumatological/orthopedic surgery, gynecology, urology) in general anesthesia according to the standard operating procedures of the department, i.e. manually controlled clinical anesthesia and EEG-derived parameters of anesthetic depth
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 90 Years
healthy volunteers: No
last name: Spies Claudia, MD, Prof.
role: Study Director
affiliation: Charite University, Berlin, Germany
facility: 
country: Germany
responsible party type: Sponsor-Investigator
investigator affiliation: Charite University, Berlin, Germany
investigator full name: Claudia Spies
investigator title: Prof. Dr. C. Claudia
mesh term: Cognitive Dysfunction