<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/NCT03013075</url>
  </required_header>
  <id_info>
    <org_study_id>INT/IEC/2016/2573</org_study_id>
    <nct_id>NCT03013075</nct_id>
  </id_info>
  <brief_title>General Plus Spinal Anesthesia and General Anesthesia Alone on Right Ventricular Function</brief_title>
  <official_title>Comparative Effect of Combined High Spinal and General Anaesthesia With General Anaesthesia Alone On Right Ventricular Function In Patients With Mitral Valvular Disease With Pulmonary Hypertension</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Postgraduate Institute of Medical Education and Research</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Postgraduate Institute of Medical Education and Research</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The investigator hypothesize that High Spinal Anesthesia (HSA) by its effect on attenuation&#xD;
      of stress response, decrease in pulmonary vascular resistance, myocardial protection and&#xD;
      positive myocardial oxygen balance will cause improvement in right ventricular function. So&#xD;
      far there is no study that has evaluated the effect of HSA anesthesia on the right&#xD;
      ventricular function, hence the investigator planned this study to compare the effect of HSA&#xD;
      on the right ventricular function in patients with mitral valve disease with moderate to&#xD;
      severe pulmonary hypertension planned for mitral valve replacement surgery.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      All study patients will undergo routine TTE and TEE examination protocol followed at the&#xD;
      investigator institution. All the other routine monitoring such as end tidal carbon dioxide,&#xD;
      urine output, ABG, ACT, BIS, electrolytes, blood sugar, hemoglobin and ventilatory parameters&#xD;
      etc for open heart surgery will be done as per institutional practice. In the study group,&#xD;
      the patients will receive spinal anesthesia after placement of invasive lines and prior to&#xD;
      induction of GA.In both the study group GA will be induced with midazolam 1-2 mg, fentanyl&#xD;
      2μ/kg and propofol titrated to achieve loss of consciousness. Inj. Vecuronium bromide&#xD;
      0.1mg/kg will be used as muscle relaxant to facilitate tracheal intubation and lignocaine&#xD;
      spray (LOX 10% spray, Neon laboratories LTD, Thane, India) will be used over vocal cords&#xD;
      prior to intubation to blunt the sympathetic stimulation.&#xD;
&#xD;
      Subsequently anesthesia will be maintained in both the groups, with isoflurane inhalation to&#xD;
      maintain BIS values between 40 to 60. In control group, fentanyl infusion 1μ/kg/hr will be&#xD;
      started for analgesia, a similar looking infusion without fentanyl will be started in the&#xD;
      spinal group.All patients will be shifted to ICU with inotropic and vasopressor support as&#xD;
      per the hemodynamic condition.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date>November 2016</start_date>
  <completion_date type="Anticipated">December 2017</completion_date>
  <primary_completion_date type="Anticipated">December 2017</primary_completion_date>
  <phase>Phase 4</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>Supportive Care</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Improvement of right ventricular function defined by 20% increase in the TAPSE in the study group when compared to the control group</measure>
    <time_frame>Till patient got discharged from ICU, an average of 5 days</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Pulmonary vascular resistance</measure>
    <time_frame>Till patient got discharged from ICU, an average of 5 days</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Left ventricular ejection fraction</measure>
    <time_frame>Till patient got discharged from ICU, an average of 5 days</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Right ventricular myocardial performance index</measure>
    <time_frame>Till patient got discharged from ICU, an average of 5 days</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mechanical ventilation duration</measure>
    <time_frame>Till patient got discharged from ICU, an average of 5 days</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Intensive care unit stay</measure>
    <time_frame>Till patient got discharged from ICU, an average of 5 days</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">50</enrollment>
  <condition>Right Ventricular Dysfunction</condition>
  <arm_group>
    <arm_group_label>SPINAL PLUS GENERAL ANESTHESIA</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patient will receive the intervention SPINAL ANESTHESIA before the start of surgery using Bupivacaine heavy 40 mg and Morphine 250 micro grams comprising a total volume of 8 ml to achieve a spinal block up to T2 level followed by general anesthesia</description>
  </arm_group>
  <arm_group>
    <arm_group_label>ONLY GENERAL ANESTHESIA</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Patient will receive only general anesthesia before the start of surgery</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Spinal anesthesia with Bupivacaine heavy and Morphine</intervention_name>
    <description>Spinal anesthesia with Bupivacaine heavy 40 mg and Morphine 250 micro grams will be given to patient in addition to the routine general anesthesia before the start of surgery</description>
    <arm_group_label>SPINAL PLUS GENERAL ANESTHESIA</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Bupivacaine heavy and Morphine</intervention_name>
    <arm_group_label>SPINAL PLUS GENERAL ANESTHESIA</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>General Anesthetics</intervention_name>
    <arm_group_label>ONLY GENERAL ANESTHESIA</arm_group_label>
    <arm_group_label>SPINAL PLUS GENERAL ANESTHESIA</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  50 consecutive patients of 18 to 60 years age,&#xD;
&#xD;
          -  NYHA class II or III,&#xD;
&#xD;
          -  with mitral valvular disease with moderate to severe PAH (mean pulmonary artery&#xD;
             pressure &gt; 40 mmHg) undergoing MVR&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  emergency or redo surgery, patients with associated CAD or other valvular heart&#xD;
             disease,&#xD;
&#xD;
          -  COPD,&#xD;
&#xD;
          -  bronchial asthma,&#xD;
&#xD;
          -  obesity (BMI more than 30), anticipated difficult airway,&#xD;
&#xD;
          -  opioid drug abuse or addiction and those with contraindication for spinal anaesthesia&#xD;
             including local site infection,&#xD;
&#xD;
          -  spinal deformity, deranged coagulogram defined by platelet count &lt; 80,000 &amp; INR &gt; 1.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>60 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>PGIMER</name>
      <address>
        <city>Chandigarh</city>
        <zip>160012</zip>
        <country>India</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>GANESH KUMAR M, MD</last_name>
      <phone>8968170779</phone>
      <email>mganeshkumar19@gmail.com</email>
    </contact>
  </location>
  <location_countries>
    <country>India</country>
  </location_countries>
  <verification_date>June 2017</verification_date>
  <study_first_submitted>January 2, 2017</study_first_submitted>
  <study_first_submitted_qc>January 5, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 6, 2017</study_first_posted>
  <last_update_submitted>June 1, 2017</last_update_submitted>
  <last_update_submitted_qc>June 1, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">June 5, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Postgraduate Institute of Medical Education and Research</investigator_affiliation>
    <investigator_full_name>Ganesh Kumar Munirathinam</investigator_full_name>
    <investigator_title>Fellow resident, Department of anesthesia and intensive care</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Ventricular Dysfunction</mesh_term>
    <mesh_term>Ventricular Dysfunction, Right</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Morphine</mesh_term>
    <mesh_term>Bupivacaine</mesh_term>
    <mesh_term>Anesthetics</mesh_term>
    <mesh_term>Anesthetics, General</mesh_term>
  </intervention_browse>
  <pending_results>
    <submitted>January 12, 2018</submitted>
    <returned>September 20, 2018</returned>
  </pending_results>
  <!-- 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/NCT03013075
org study id: INT/IEC/2016/2573
nct id: NCT03013075
lead sponsor: 
has dmc: No
The investigator hypothesize that High Spinal Anesthesia (HSA) by its effect on attenuation
      of stress response, decrease in pulmonary vascular resistance, myocardial protection and
      positive myocardial oxygen balance will cause improvement in right ventricular function. So
      far there is no study that has evaluated the effect of HSA anesthesia on the right
      ventricular function, hence the investigator planned this study to compare the effect of HSA
      on the right ventricular function in patients with mitral valve disease with moderate to
      severe pulmonary hypertension planned for mitral valve replacement surgery.
All study patients will undergo routine TTE and TEE examination protocol followed at the
      investigator institution. All the other routine monitoring such as end tidal carbon dioxide,
      urine output, ABG, ACT, BIS, electrolytes, blood sugar, hemoglobin and ventilatory parameters
      etc for open heart surgery will be done as per institutional practice. In the study group,
      the patients will receive spinal anesthesia after placement of invasive lines and prior to
      induction of GA.In both the study group GA will be induced with midazolam 1-2 mg, fentanyl
      2μ/kg and propofol titrated to achieve loss of consciousness. Inj. Vecuronium bromide
      0.1mg/kg will be used as muscle relaxant to facilitate tracheal intubation and lignocaine
      spray (LOX 10% spray, Neon laboratories LTD, Thane, India) will be used over vocal cords
      prior to intubation to blunt the sympathetic stimulation.

      Subsequently anesthesia will be maintained in both the groups, with isoflurane inhalation to
      maintain BIS values between 40 to 60. In control group, fentanyl infusion 1μ/kg/hr will be
      started for analgesia, a similar looking infusion without fentanyl will be started in the
      spinal group.All patients will be shifted to ICU with inotropic and vasopressor support as
      per the hemodynamic condition.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Supportive Care
masking: None (Open Label)
measure: Improvement of right ventricular function defined by 20% increase in the TAPSE in the study group when compared to the control group
time frame: Till patient got discharged from ICU, an average of 5 days
measure: Pulmonary vascular resistance
time frame: Till patient got discharged from ICU, an average of 5 days
measure: Left ventricular ejection fraction
time frame: Till patient got discharged from ICU, an average of 5 days
measure: Right ventricular myocardial performance index
time frame: Till patient got discharged from ICU, an average of 5 days
measure: Mechanical ventilation duration
time frame: Till patient got discharged from ICU, an average of 5 days
measure: Intensive care unit stay
time frame: Till patient got discharged from ICU, an average of 5 days
arm group label: SPINAL PLUS GENERAL ANESTHESIA
arm group type: Experimental
description: Patient will receive the intervention SPINAL ANESTHESIA before the start of surgery using Bupivacaine heavy 40 mg and Morphine 250 micro grams comprising a total volume of 8 ml to achieve a spinal block up to T2 level followed by general anesthesia
arm group label: ONLY GENERAL ANESTHESIA
arm group type: Active Comparator
description: Patient will receive only general anesthesia before the start of surgery
intervention type: Procedure
intervention name: Spinal anesthesia with Bupivacaine heavy and Morphine
description: Spinal anesthesia with Bupivacaine heavy 40 mg and Morphine 250 micro grams will be given to patient in addition to the routine general anesthesia before the start of surgery
arm group label: SPINAL PLUS GENERAL ANESTHESIA
intervention type: Drug
intervention name: Bupivacaine heavy and Morphine
arm group label: SPINAL PLUS GENERAL ANESTHESIA
intervention type: Drug
intervention name: General Anesthetics
arm group label: ONLY GENERAL ANESTHESIA
arm group label: SPINAL PLUS GENERAL ANESTHESIA
criteria: 
gender: All
minimum age: 18 Years
maximum age: 60 Years
healthy volunteers: No
facility: 
status: Recruiting
contact: 
country: India
responsible party type: Principal Investigator
investigator affiliation: Postgraduate Institute of Medical Education and Research
investigator full name: Ganesh Kumar Munirathinam
investigator title: Fellow resident, Department of anesthesia and intensive care
mesh term: Ventricular Dysfunction
mesh term: Ventricular Dysfunction, Right
mesh term: Morphine
mesh term: Bupivacaine
mesh term: Anesthetics
mesh term: Anesthetics, General
submitted: January 12, 2018
returned: September 20, 2018