<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/NCT03773588</url>
  </required_header>
  <id_info>
    <org_study_id>SMCH01</org_study_id>
    <nct_id>NCT03773588</nct_id>
  </id_info>
  <brief_title>Entropy and Surgical Pleth Index Guided Closed Loop Target Controlled Infusion Total Intravenous Anesthesia With Propofol</brief_title>
  <acronym>Closedloop TCI</acronym>
  <official_title>Spatial Entropy and Surgical Pleth Index Guided Closed Loop Target Controlled Infusion (TCI) Total Intravenous Anaesthesia (TIVA) With Propofol</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>KVG Medical College and Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>KVG Medical College and Hospital</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      Closed-loop infusion system for target controlled infusion of propofol by using TCI pump&#xD;
      designed by BD Technology. (Germany) guided with entropy and surgical pleth index (GE) will&#xD;
      not only prevent awareness from Anesthesia but also optimise the dose anesthetic agents based&#xD;
      on feedback from adequacy of Anesthesia monitoring. Which not only reduces Anesthesia agents&#xD;
      but also enhances recovery from Anesthesia. Innovation using TCI combined with closed-loop&#xD;
      controlled intravenous anesthesia under the guide of Entropy.In this study we performed a&#xD;
      randomized, controlled, study to compare closed-loop control and open-loop control of&#xD;
      propofol by using the Entropy and SPI guided closed-loop infusion system.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Monitoring of Adequacy of Anesthesia using Entropy and Surgical pleth index to guide total&#xD;
      intravenous anesthesia is more effective to maintain depth of anesthesia compared with target&#xD;
      controlled infusion with open systems, it is unclear what driver and variables to achieve&#xD;
      this goal be more physiological; in the literature doesn´t exist studies showing that the&#xD;
      closed-loop system for hypnotic is better than the controlled algorithm based pharmacokinetic&#xD;
      models and open loop system (target controlled infusion-TCI) to maintain anesthetic depth.&#xD;
      Thus, a system was designed for intravenous anesthesia in closed loop for propofol as&#xD;
      hypnotic based on neuromonitoring with Entropy and surgical pleth index as adequacy of&#xD;
      Anesthesia depth.&#xD;
&#xD;
      The purpose of this study is to determine the therapeutic effectiveness of a closed loop TCI&#xD;
      for administration of intravenous anesthesia using adequacy of anesthesia monitoring to&#xD;
      maintain a depth of anesthesia compared to an open loop system TCI.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">October 10, 2018</start_date>
  <completion_date type="Anticipated">January 15, 2019</completion_date>
  <primary_completion_date type="Anticipated">January 10, 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>Sequential Assignment</intervention_model>
    <intervention_model_description>Device: Closed-Loop propofol TCI with Entropy and SPI Device: Open-Loop propofol by Target Controlled Infusion Drug: propofol</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Adequacy of anesthesia</measure>
    <time_frame>1 day</time_frame>
    <description>Difference in therapeutic effectiveness determined by the time in state suitable anesthetic depth. The proper anesthetic depth is defined as the efficacy to maintain a Spatial entropy in the range of 40 - 60 during a surgery.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Time taken for recovery from Anesthesia</measure>
    <time_frame>1 day</time_frame>
    <description>Total time taken for recovery after stopping of infusion</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Total consumption of propofol</measure>
    <time_frame>1 day</time_frame>
    <description>Total consumption of propofol during surgery</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of hypotension events</measure>
    <time_frame>1 day</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">40</enrollment>
  <condition>Anesthesia Awareness</condition>
  <arm_group>
    <arm_group_label>Closed-Loop propofol Target control infusion</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Closed loop target controlled infusion(TCI) TIVA with propofol using BD TCI pumps guided by entropy and SPI</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Open-loop propofol target control infusion</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Open-loop target controlled infusion of propofol using BD TCI pumps based on Schnider effect site algorithm</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Closed-Loop propofol Target controlled infusion by Entropy and SPI</intervention_name>
    <description>Closed loop target infusion of propofol using BD TCI pumps guided by entropy and Surgical pleth index</description>
    <arm_group_label>Closed-Loop propofol Target control infusion</arm_group_label>
    <other_name>Closed-loop propofol Target controlled infusion</other_name>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Open-loop propofol target controlled infusion</intervention_name>
    <description>Propofol target controlled infusion using Schnider algorithm to determine effect site concentration</description>
    <arm_group_label>Open-loop propofol target control infusion</arm_group_label>
    <other_name>Open-loop propofol TCI</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Older than 18 years&#xD;
&#xD;
          -  Scheduled for noncardiac surgery elective low-risk or intermediate risk. -Expected&#xD;
             surgery time greater than 1 hour&#xD;
&#xD;
          -  Procedure requiring general anesthesia&#xD;
&#xD;
          -  Classification of the American Society of Anesthesiologists (ASA) as I,II, lll&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Pregnant women&#xD;
&#xD;
          -  Surgery scheduled urgent or emergency&#xD;
&#xD;
          -  Personal history of allergy to eggs or any other part of propofol&#xD;
&#xD;
          -  Personal history of abnormalities or congenital or acquired cognitive sequels:&#xD;
             infantile cerebral palsy, Down syndrome, cerebral ischemic disease, traumatic brain&#xD;
             injury, brain tumor, autism.&#xD;
&#xD;
          -  Chronic use of benzodiazepines or antipsychotics&#xD;
&#xD;
          -  A patient who does not consent to participate in the study prior to surgery or before&#xD;
             randomization&#xD;
&#xD;
          -  Need for anesthetic or analgesic blockade before surgery peripheral nerve&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>100 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Subbaih institute of medical sciences</name>
      <address>
        <city>Shimoga</city>
        <state>Karnataka</state>
        <country>India</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Shivakumar M Channabasappa, MD</last_name>
      <phone>9620306582</phone>
      <email>drshivakumar.m.c@gmail.com</email>
    </contact>
  </location>
  <location_countries>
    <country>India</country>
  </location_countries>
  <verification_date>December 2018</verification_date>
  <study_first_submitted>December 10, 2018</study_first_submitted>
  <study_first_submitted_qc>December 11, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 12, 2018</study_first_posted>
  <last_update_submitted>December 11, 2018</last_update_submitted>
  <last_update_submitted_qc>December 11, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">December 12, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>KVG Medical College and Hospital</investigator_affiliation>
    <investigator_full_name>Shivakumar M C, MD</investigator_full_name>
    <investigator_title>Professor and HEAD, Department of Anesthesiologist and critical care medicine</investigator_title>
  </responsible_party>
  <keyword>Closed loop</keyword>
  <keyword>Entropy</keyword>
  <keyword>Surgical pleth index</keyword>
  <keyword>Adequacy of Anesthesia</keyword>
  <keyword>Target controlled infusion</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Intraoperative Awareness</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Propofol</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>Undecided</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/NCT03773588
org study id: SMCH01
nct id: NCT03773588
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
is us export: No
Closed-loop infusion system for target controlled infusion of propofol by using TCI pump
      designed by BD Technology. (Germany) guided with entropy and surgical pleth index (GE) will
      not only prevent awareness from Anesthesia but also optimise the dose anesthetic agents based
      on feedback from adequacy of Anesthesia monitoring. Which not only reduces Anesthesia agents
      but also enhances recovery from Anesthesia. Innovation using TCI combined with closed-loop
      controlled intravenous anesthesia under the guide of Entropy.In this study we performed a
      randomized, controlled, study to compare closed-loop control and open-loop control of
      propofol by using the Entropy and SPI guided closed-loop infusion system.
Monitoring of Adequacy of Anesthesia using Entropy and Surgical pleth index to guide total
      intravenous anesthesia is more effective to maintain depth of anesthesia compared with target
      controlled infusion with open systems, it is unclear what driver and variables to achieve
      this goal be more physiological; in the literature doesn´t exist studies showing that the
      closed-loop system for hypnotic is better than the controlled algorithm based pharmacokinetic
      models and open loop system (target controlled infusion-TCI) to maintain anesthetic depth.
      Thus, a system was designed for intravenous anesthesia in closed loop for propofol as
      hypnotic based on neuromonitoring with Entropy and surgical pleth index as adequacy of
      Anesthesia depth.

      The purpose of this study is to determine the therapeutic effectiveness of a closed loop TCI
      for administration of intravenous anesthesia using adequacy of anesthesia monitoring to
      maintain a depth of anesthesia compared to an open loop system TCI.
allocation: Randomized
intervention model: Sequential Assignment
intervention model description: Device: Closed-Loop propofol TCI with Entropy and SPI Device: Open-Loop propofol by Target Controlled Infusion Drug: propofol
primary purpose: Treatment
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: Adequacy of anesthesia
time frame: 1 day
description: Difference in therapeutic effectiveness determined by the time in state suitable anesthetic depth. The proper anesthetic depth is defined as the efficacy to maintain a Spatial entropy in the range of 40 - 60 during a surgery.
measure: Time taken for recovery from Anesthesia
time frame: 1 day
description: Total time taken for recovery after stopping of infusion
measure: Total consumption of propofol
time frame: 1 day
description: Total consumption of propofol during surgery
measure: Number of hypotension events
time frame: 1 day
arm group label: Closed-Loop propofol Target control infusion
arm group type: Active Comparator
description: Closed loop target controlled infusion(TCI) TIVA with propofol using BD TCI pumps guided by entropy and SPI
arm group label: Open-loop propofol target control infusion
arm group type: Active Comparator
description: Open-loop target controlled infusion of propofol using BD TCI pumps based on Schnider effect site algorithm
intervention type: Device
intervention name: Closed-Loop propofol Target controlled infusion by Entropy and SPI
description: Closed loop target infusion of propofol using BD TCI pumps guided by entropy and Surgical pleth index
arm group label: Closed-Loop propofol Target control infusion
other name: Closed-loop propofol Target controlled infusion
intervention type: Device
intervention name: Open-loop propofol target controlled infusion
description: Propofol target controlled infusion using Schnider algorithm to determine effect site concentration
arm group label: Open-loop propofol target control infusion
other name: Open-loop propofol TCI
criteria: 
gender: All
minimum age: 18 Years
maximum age: 100 Years
healthy volunteers: No
facility: 
status: Recruiting
contact: 
country: India
responsible party type: Principal Investigator
investigator affiliation: KVG Medical College and Hospital
investigator full name: Shivakumar M C, MD
investigator title: Professor and HEAD, Department of Anesthesiologist and critical care medicine
mesh term: Intraoperative Awareness
mesh term: Propofol
sharing ipd: Undecided