<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/NCT03807271</url>
  </required_header>
  <id_info>
    <org_study_id>2018/2176</org_study_id>
    <nct_id>NCT03807271</nct_id>
  </id_info>
  <brief_title>Calculated and Graphically Produced Depth of Anesthesia</brief_title>
  <official_title>Computer-assisted Anaesthesia Using Pharmacokinetic/Pharmacodynamic Model</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Norwegian University of Science and Technology</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Sykehuset Innlandet HF</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Norwegian University of Science and Technology</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      There are studies that suggest that unsatisfying levels of anesthesia can cause peri- and&#xD;
      postoperative complications in the patient undergoing surgery. Having a unnecessary &quot;deep&quot;&#xD;
      anesthesia level can be harmful, causing acute renal failure, injure to myocard, cause&#xD;
      delirium and increase the mortality rate. Being too &quot;light&quot;, on the other hand, can make the&#xD;
      patient experience awareness when muscle relaxant is used. This can lead to serious&#xD;
      psychological struggles.&#xD;
&#xD;
      Evaluating the depth of anesthesia is the most important task of the anesthesia team, but can&#xD;
      be difficult because clinical signs depend on many factors. In addition to clinical&#xD;
      evaluation, EEG is commonly used for interpreting the level of anesthesia in todays practice.&#xD;
      Unfortunately, this method is not always accurate and has a delay.&#xD;
&#xD;
      New devices are now developed to calculate the anesthesia level based on the drugs given. The&#xD;
      level is simultaneously presented graphically on screen. The purpose of this study is to&#xD;
      investigate and compare clinical parameters within patients undergoing general anesthesia,&#xD;
      with and without the use of such devices. Hemodynamic stability, less use of adrenergics,&#xD;
      higher EEG-levels, a more rapid wake-up and shorter time in post operative care can indicate&#xD;
      a more precise level of anesthesia, hence, promote patient safety.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 14, 2019</start_date>
  <completion_date type="Actual">November 13, 2019</completion_date>
  <primary_completion_date type="Actual">November 13, 2019</primary_completion_date>
  <phase>N/A</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>Prevention</primary_purpose>
    <masking>Single (Participant)</masking>
    <masking_description>The anesthesia team must know if the anesthesia will be given by standard procedure or guided by the calculating device in addition.</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Mean Arterial Pressure (MAP)</measure>
    <time_frame>Maximum 5 hours</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Heart Rate (HR)</measure>
    <time_frame>Maximum 5 hours</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Bispectral Index (BIS)</measure>
    <time_frame>Maximum 5 hours</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Total dosis of Propofol in milligrams</measure>
    <time_frame>Maximum 5 hours</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Total dosis of Remifentanil in micrograms</measure>
    <time_frame>Maximum 5 hours</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Total dosis of Ephedrine in milligrams</measure>
    <time_frame>Maximum 5 hours</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Total dosis of Phenylephrine in micrograms</measure>
    <time_frame>Maximum 5 hours</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Total dosis of Atropine in micrograms</measure>
    <time_frame>Maximum 5 hours</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Total dosis of Norepinephrine in micrograms</measure>
    <time_frame>Maximum 5 hours</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Duration of surgery in minutes</measure>
    <time_frame>Maximum 5 hours</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Duration of anesthesia in minutes</measure>
    <time_frame>Maximum 5 hours</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time until extubation in minutes</measure>
    <time_frame>Maximum 5 hours</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Duration of stay in postoperative ward in minutes</measure>
    <time_frame>Maximum 2 days</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">114</enrollment>
  <condition>Anesthesia, General</condition>
  <arm_group>
    <arm_group_label>Smart Pilot(R) View</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Anesthesia provided by standard procedure, additionally guided by Smart Pilot(R) View, a device with calculated and graphically produced depth of anesthesia.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Standard</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Anesthesia provided by standard procedure.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Calculated and graphically produced depth of anesthesia (Smart Pilot® View)</intervention_name>
    <description>Smart Pilot® View is a device integrated in the ventilator used under general anesthesia. The depth of anesthesia is calculated based on age, weight, height and the medication given - both volatiles and intravenous. The device does not control the supply of medication directly, but provides an estimate of anesthesia depth that can help the anesthesia team to control the supply of anesthetic agents under general anesthesia, ie indirectly.</description>
    <arm_group_label>Smart Pilot(R) View</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  ASA 1-3&#xD;
&#xD;
          -  Standard premedication&#xD;
&#xD;
          -  General anesthesia, total intravenous anesthesia&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Alcoholics&#xD;
&#xD;
          -  BMI 35 or higher&#xD;
&#xD;
          -  Unable to give consent&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>75 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Heidi Vifladt, MD</last_name>
    <role>Study Director</role>
    <affiliation>Norwegian University of Science and Technology</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Anestesiavdeling Lillehammer Sykehus</name>
      <address>
        <city>Lillehammer</city>
        <state>Oppland</state>
        <zip>2609</zip>
        <country>Norway</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Norway</country>
  </location_countries>
  <verification_date>December 2019</verification_date>
  <study_first_submitted>January 9, 2019</study_first_submitted>
  <study_first_submitted_qc>January 12, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 16, 2019</study_first_posted>
  <last_update_submitted>December 10, 2019</last_update_submitted>
  <last_update_submitted_qc>December 10, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">December 11, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Anesthesia, Methods</keyword>
  <keyword>Anesthesia, Analysis</keyword>
  <keyword>Patient Safety</keyword>
  <keyword>Anesthetics/administration and dosage</keyword>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Anesthetics</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- 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/NCT03807271
org study id: 2018/2176
nct id: NCT03807271
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
There are studies that suggest that unsatisfying levels of anesthesia can cause peri- and
      postoperative complications in the patient undergoing surgery. Having a unnecessary "deep"
      anesthesia level can be harmful, causing acute renal failure, injure to myocard, cause
      delirium and increase the mortality rate. Being too "light", on the other hand, can make the
      patient experience awareness when muscle relaxant is used. This can lead to serious
      psychological struggles.

      Evaluating the depth of anesthesia is the most important task of the anesthesia team, but can
      be difficult because clinical signs depend on many factors. In addition to clinical
      evaluation, EEG is commonly used for interpreting the level of anesthesia in todays practice.
      Unfortunately, this method is not always accurate and has a delay.

      New devices are now developed to calculate the anesthesia level based on the drugs given. The
      level is simultaneously presented graphically on screen. The purpose of this study is to
      investigate and compare clinical parameters within patients undergoing general anesthesia,
      with and without the use of such devices. Hemodynamic stability, less use of adrenergics,
      higher EEG-levels, a more rapid wake-up and shorter time in post operative care can indicate
      a more precise level of anesthesia, hence, promote patient safety.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: Single (Participant)
masking description: The anesthesia team must know if the anesthesia will be given by standard procedure or guided by the calculating device in addition.
measure: Mean Arterial Pressure (MAP)
time frame: Maximum 5 hours
measure: Heart Rate (HR)
time frame: Maximum 5 hours
measure: Bispectral Index (BIS)
time frame: Maximum 5 hours
measure: Total dosis of Propofol in milligrams
time frame: Maximum 5 hours
measure: Total dosis of Remifentanil in micrograms
time frame: Maximum 5 hours
measure: Total dosis of Ephedrine in milligrams
time frame: Maximum 5 hours
measure: Total dosis of Phenylephrine in micrograms
time frame: Maximum 5 hours
measure: Total dosis of Atropine in micrograms
time frame: Maximum 5 hours
measure: Total dosis of Norepinephrine in micrograms
time frame: Maximum 5 hours
measure: Duration of surgery in minutes
time frame: Maximum 5 hours
measure: Duration of anesthesia in minutes
time frame: Maximum 5 hours
measure: Time until extubation in minutes
time frame: Maximum 5 hours
measure: Duration of stay in postoperative ward in minutes
time frame: Maximum 2 days
arm group label: Smart Pilot(R) View
arm group type: Experimental
description: Anesthesia provided by standard procedure, additionally guided by Smart Pilot(R) View, a device with calculated and graphically produced depth of anesthesia.
arm group label: Standard
arm group type: No Intervention
description: Anesthesia provided by standard procedure.
intervention type: Device
intervention name: Calculated and graphically produced depth of anesthesia (Smart Pilot® View)
description: Smart Pilot® View is a device integrated in the ventilator used under general anesthesia. The depth of anesthesia is calculated based on age, weight, height and the medication given - both volatiles and intravenous. The device does not control the supply of medication directly, but provides an estimate of anesthesia depth that can help the anesthesia team to control the supply of anesthetic agents under general anesthesia, ie indirectly.
arm group label: Smart Pilot(R) View
criteria: 
gender: Female
minimum age: 18 Years
maximum age: 75 Years
healthy volunteers: No
last name: Heidi Vifladt, MD
role: Study Director
affiliation: Norwegian University of Science and Technology
facility: 
country: Norway
responsible party type: Sponsor
mesh term: Anesthetics
sharing ipd: No