<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/NCT03807297</url>
  </required_header>
  <id_info>
    <org_study_id>RajivGCIRC2</org_study_id>
    <nct_id>NCT03807297</nct_id>
  </id_info>
  <brief_title>TIVA vs Inhalational Mode of Anaesthesia</brief_title>
  <official_title>Comparative Study Between TIVA Vs Inhalational Modes of Anaesthesia in Patients Undergoing Modified Radical Mastectomy</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Rajiv Gandhi Cancer Institute &amp; Research Center, India</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Rajiv Gandhi Cancer Institute &amp; Research Center, India</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>
      Sevoflurane based inhalational anaesthesia is the preferred mode of anesthesia for small&#xD;
      duration cases. But in recent times, concept of rapid discharge, day care procedures, and&#xD;
      green environment has created the need of new modalities of anaesthesia for such cases.&#xD;
      Considering such factor, investigators have planned using TIVA i.e. total intravenous&#xD;
      anaesthesia with Inj. Propofol and Inj. Dexmedetomidine infusions for maintenance of&#xD;
      anesthesia in Modified Radical Mastectomy (MRM). By comparing the two modalities of&#xD;
      anaesthesia i.e. TIVA vs Inhalational investigators are trying to find out whether TIVA is&#xD;
      feasible, cost effective and comparable to inhalational anaesthesia in terms of&#xD;
      intraoperative hemodynamic stability, pain, intraoperative awareness and recovery profile.&#xD;
      This comparison and analysis will help to determine if TIVA can be used as the sole mode of&#xD;
      anaesthesia during MRM as it will initiate early discharge of patient and will contribute to&#xD;
      the Green OT concept.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Aim: To compare TIVA Vs Inhalational mode of anaesthesia in patients undergoing Modified&#xD;
      Radical Mastectomy&#xD;
&#xD;
      Objective:&#xD;
&#xD;
        -  Feasibility of TIVA in Modified Radical Mastectomy&#xD;
&#xD;
        -  Cost - effectiveness of TIVA Vs Inhalational anesthesia&#xD;
&#xD;
        -  Effectiveness of TIVA as compared to Inhalational Anaesthesia by comparing&#xD;
           intraoperative hemodynamic parameters and recovery profile.&#xD;
&#xD;
      Study design: It will be a prospective randomized controlled interventional type of study.&#xD;
&#xD;
      Sample size: Total 100 patients will be recruited for two groups i.e. 50 each in -TIVA (T)&#xD;
      and Inhalational (I) group. Groups will be allocated as per chit system to remove the bias.&#xD;
&#xD;
      In group T: (TIVA): Inj. Dexmedetomidine will be started at induction @1mcg/kg over 10 min&#xD;
      followed by 0.2 to 0.7 mcg/kg/hr along with propofol @ 75mcg/kg/min (25-100 mcg/kg/min) for&#xD;
      maintenance of anaesthesia.&#xD;
&#xD;
      In group I: (inhalational): both nitrous oxide (in ratio of 50:50 with oxygen) and&#xD;
      sevoflurane will be started at induction.&#xD;
&#xD;
      In both groups drugs and gases (respective to groups) will be titrated to maintain a&#xD;
      bispectral index value between 40-60. Anaesthetic drugs will be stopped at last skin suture.&#xD;
      Soon after reversal- recovery profile, modified Aldrete score will be recorded along with&#xD;
      time taken to first eye opening and attainment of BIS value of &gt;90. At the end of case amount&#xD;
      of each agents consumed will be recorded - i.e. nitrous oxide, sevoflurane, propofol,&#xD;
      dexmedetomodine- for cost analysis.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 10, 2019</start_date>
  <completion_date type="Actual">December 30, 2019</completion_date>
  <primary_completion_date type="Actual">November 30, 2019</primary_completion_date>
  <phase>Phase 2</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>
    <intervention_model_description>two groups - one for Total Intravenous Anaesthesia mode and other for Inhalational mode of anaesthesia</intervention_model_description>
    <primary_purpose>Other</primary_purpose>
    <masking>Double (Participant, Investigator)</masking>
    <masking_description>participants will be alloted in two groups as per chit system and won't be aware of type of anaesthesia, investigator won't be aware of type of anaesthesia and will record the data.</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>total intravenous anesthesia</measure>
    <time_frame>3 hours</time_frame>
    <description>Intraoperative Bispectral index maintenance between 40-60</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Cost - effectiveness</measure>
    <time_frame>3 hours</time_frame>
    <description>cost of drugs consumed per patient in both groups</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">100</enrollment>
  <condition>Anesthesia Awareness</condition>
  <arm_group>
    <arm_group_label>TIVA - total intravenous anaesthesia</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>only intravenous type of anaesthesia using Injection propofol, 10 mg and Injection dexmedetomidine drug infusion will be infused for maintenance of anaesthesia</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Inhalational anaesthesia</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>In this group, both nitrous oxide and sevoflurane will be given for maintenance of anaesthesia</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Injection dexmedetomidine</intervention_name>
    <description>alpha 2 a agonist used for sedation, analgesia</description>
    <arm_group_label>TIVA - total intravenous anaesthesia</arm_group_label>
    <other_name>dexmed</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Injection, Propofol, 10 Mg</intervention_name>
    <description>non barbiturate type of intravenous anaesthetic drug</description>
    <arm_group_label>TIVA - total intravenous anaesthesia</arm_group_label>
    <other_name>propofol spiva</other_name>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>sevoflurane</intervention_name>
    <description>inhalational anaesthetic agent</description>
    <arm_group_label>Inhalational anaesthesia</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>nitrous oxide</intervention_name>
    <description>inhalational anaesthetic agent</description>
    <arm_group_label>Inhalational anaesthesia</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Age group: 30-65 yrs&#xD;
&#xD;
          -  ASA status: 1-3&#xD;
&#xD;
          -  Use of endotracheal tube for securing the airway&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  CKD, CLD patients&#xD;
&#xD;
          -  Cardiac dysfunction&#xD;
&#xD;
          -  Psychotic and neurotic disorders&#xD;
&#xD;
          -  Drug addiction&#xD;
&#xD;
          -  BMI &gt; 30&#xD;
&#xD;
          -  Use of supraglottic device&#xD;
&#xD;
          -  Use of any nerve blocks&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>30 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>NITESH GOEL, MBBS,DA,DNB</last_name>
    <role>Principal Investigator</role>
    <affiliation>Rajiv Gandhi Cancer Institute And Research Centre</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Rajiv Gandhi Cancer Institute and Research Centre</name>
      <address>
        <city>New Delhi</city>
        <state>Delhi</state>
        <zip>110085</zip>
        <country>India</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>India</country>
  </location_countries>
  <verification_date>February 2020</verification_date>
  <study_first_submitted>January 5, 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>February 16, 2020</last_update_submitted>
  <last_update_submitted_qc>February 16, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">February 19, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Rajiv Gandhi Cancer Institute &amp; Research Center, India</investigator_affiliation>
    <investigator_full_name>Dr. Nitesh Goel</investigator_full_name>
    <investigator_title>Dr. Nitesh Goel - Consultant Anaesthesia</investigator_title>
  </responsible_party>
  <keyword>total intravenous anesthesia</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>Dexmedetomidine</mesh_term>
    <mesh_term>Nitrous Oxide</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/NCT03807297
org study id: RajivGCIRC2
nct id: NCT03807297
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
is us export: No
Sevoflurane based inhalational anaesthesia is the preferred mode of anesthesia for small
      duration cases. But in recent times, concept of rapid discharge, day care procedures, and
      green environment has created the need of new modalities of anaesthesia for such cases.
      Considering such factor, investigators have planned using TIVA i.e. total intravenous
      anaesthesia with Inj. Propofol and Inj. Dexmedetomidine infusions for maintenance of
      anesthesia in Modified Radical Mastectomy (MRM). By comparing the two modalities of
      anaesthesia i.e. TIVA vs Inhalational investigators are trying to find out whether TIVA is
      feasible, cost effective and comparable to inhalational anaesthesia in terms of
      intraoperative hemodynamic stability, pain, intraoperative awareness and recovery profile.
      This comparison and analysis will help to determine if TIVA can be used as the sole mode of
      anaesthesia during MRM as it will initiate early discharge of patient and will contribute to
      the Green OT concept.
Aim: To compare TIVA Vs Inhalational mode of anaesthesia in patients undergoing Modified
      Radical Mastectomy

      Objective:

        -  Feasibility of TIVA in Modified Radical Mastectomy

        -  Cost - effectiveness of TIVA Vs Inhalational anesthesia

        -  Effectiveness of TIVA as compared to Inhalational Anaesthesia by comparing
           intraoperative hemodynamic parameters and recovery profile.

      Study design: It will be a prospective randomized controlled interventional type of study.

      Sample size: Total 100 patients will be recruited for two groups i.e. 50 each in -TIVA (T)
      and Inhalational (I) group. Groups will be allocated as per chit system to remove the bias.

      In group T: (TIVA): Inj. Dexmedetomidine will be started at induction @1mcg/kg over 10 min
      followed by 0.2 to 0.7 mcg/kg/hr along with propofol @ 75mcg/kg/min (25-100 mcg/kg/min) for
      maintenance of anaesthesia.

      In group I: (inhalational): both nitrous oxide (in ratio of 50:50 with oxygen) and
      sevoflurane will be started at induction.

      In both groups drugs and gases (respective to groups) will be titrated to maintain a
      bispectral index value between 40-60. Anaesthetic drugs will be stopped at last skin suture.
      Soon after reversal- recovery profile, modified Aldrete score will be recorded along with
      time taken to first eye opening and attainment of BIS value of >90. At the end of case amount
      of each agents consumed will be recorded - i.e. nitrous oxide, sevoflurane, propofol,
      dexmedetomodine- for cost analysis.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: two groups - one for Total Intravenous Anaesthesia mode and other for Inhalational mode of anaesthesia
primary purpose: Other
masking: Double (Participant, Investigator)
masking description: participants will be alloted in two groups as per chit system and won't be aware of type of anaesthesia, investigator won't be aware of type of anaesthesia and will record the data.
measure: total intravenous anesthesia
time frame: 3 hours
description: Intraoperative Bispectral index maintenance between 40-60
measure: Cost - effectiveness
time frame: 3 hours
description: cost of drugs consumed per patient in both groups
arm group label: TIVA - total intravenous anaesthesia
arm group type: Other
description: only intravenous type of anaesthesia using Injection propofol, 10 mg and Injection dexmedetomidine drug infusion will be infused for maintenance of anaesthesia
arm group label: Inhalational anaesthesia
arm group type: Other
description: In this group, both nitrous oxide and sevoflurane will be given for maintenance of anaesthesia
intervention type: Drug
intervention name: Injection dexmedetomidine
description: alpha 2 a agonist used for sedation, analgesia
arm group label: TIVA - total intravenous anaesthesia
other name: dexmed
intervention type: Drug
intervention name: Injection, Propofol, 10 Mg
description: non barbiturate type of intravenous anaesthetic drug
arm group label: TIVA - total intravenous anaesthesia
other name: propofol spiva
intervention type: Other
intervention name: sevoflurane
description: inhalational anaesthetic agent
arm group label: Inhalational anaesthesia
intervention type: Other
intervention name: nitrous oxide
description: inhalational anaesthetic agent
arm group label: Inhalational anaesthesia
criteria: 
gender: All
minimum age: 30 Years
maximum age: 65 Years
healthy volunteers: Accepts Healthy Volunteers
last name: NITESH GOEL, MBBS,DA,DNB
role: Principal Investigator
affiliation: Rajiv Gandhi Cancer Institute And Research Centre
facility: 
country: India
responsible party type: Principal Investigator
investigator affiliation: Rajiv Gandhi Cancer Institute & Research Center, India
investigator full name: Dr. Nitesh Goel
investigator title: Dr. Nitesh Goel - Consultant Anaesthesia
mesh term: Intraoperative Awareness
mesh term: Dexmedetomidine
mesh term: Nitrous Oxide
mesh term: Propofol
mesh term: Sevoflurane