xml: <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/NCT05993039</url>
    </required_header>
    <id_info>
      <org_study_id>TIVA in Ear Surgery</org_study_id>
      <nct_id>NCT05993039</nct_id>
    </id_info>
    <brief_title>Inhalational Anesthesia vs TIVA in Endoscopic Tympanoplasty</brief_title>
    <acronym>TIVA</acronym>
    <official_title>Comparison of Inhalational Anesthesia and Total Intravenous Anesthesia on Surgical Field Quality and Post-operative Recovery in Endoscopic Tympanoplasty</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Our Lady of the Lake Hospital</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
      <collaborator>
        <agency>Louisiana State University Health Sciences Center in New Orleans</agency>
        <agency_class>Other</agency_class>
      </collaborator>
    </sponsors>
    <source>Our Lady of the Lake Hospital</source>
    <oversight_info>
      <has_dmc>No</has_dmc>
      <is_fda_regulated_drug>Yes</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>
        This study aims to prospectively compare surgical field quality and intraoperative blood loss&#xD;
        between general inhalational anesthesia to total intravenous anesthesia (TIVA) alone in&#xD;
        subjects undergoing endoscopic ear surgery. A secondary objective is to compare rates of&#xD;
        emergence delirium and total recovery time between the two groups.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        In sinus surgery, TIVA has been described as a possible advantage in the use of endoscopic&#xD;
        ear surgery. However, to date, there are no studies that examine blood loss, surgical field&#xD;
        quality, and recovery in TIVA compared to inhalational anesthesia in the setting of&#xD;
        endoscopic ear surgery. The hypothesis is that in patients who undergo endoscopic&#xD;
        tympanoplasty, those who receive TIVA will have reduced intraoperative blood loss, improved&#xD;
        surgical field quality, and reduced emergence agitation than those who receive inhalational&#xD;
        anesthesia. This study will be a prospective double-blinded randomized control trial&#xD;
        consisting of subjects undergoing endoscopic tympanoplasty surgery to assess intraoperative&#xD;
        blood loss, surgical field quality, rates of emergence delirium, and recovery time.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">September 1, 2023</start_date>
    <completion_date type="Anticipated">December 31, 2024</completion_date>
    <primary_completion_date type="Anticipated">December 31, 2024</primary_completion_date>
    <phase>Early Phase 1</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>double-blinded randomized control</intervention_model_description>
      <primary_purpose>Treatment</primary_purpose>
      <masking>Double (Participant, Care Provider)</masking>
      <masking_description>In the operating room, in order to blind the surgeon to the type of anesthesia used, a surgical drape will be placed in between the subject and the anesthesia team to conceal the anesthesia machinery and equipment. A sham intravenous pole will be at the anesthesia workstation for those subjects in the control arm to contribute to the blinding of the surgeon. Patients will not be informed about which arm they are randomly assigned to and only the anesthesiologist will be aware prior to the surgery.</masking_description>
    </study_design_info>
    <primary_outcome>
      <measure>Surgical Field Quality</measure>
      <time_frame>Post-Operative evaluation (within 2 weeks)</time_frame>
      <description>Neurotologists will evaluate endoscopic video clips from each surgery to assess clarity of field at different points in the surgery using the Boezaart scale grading system. It is a scale from 0-5, with 0 being the most favorable outcome and 5 being the least favorable outcome.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Intra-operative blood loss</measure>
      <time_frame>1-2 hours during surgery</time_frame>
      <description>Intraoperative blood loss will be determined by measuring the total number of pledgets needed to attain hemostatsis. This will be a general observation with the more pledgets needed to stop bleeding in the surgical area indicates more possible blood loss than the procedures with that require less pledgets.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Emergent Delirium and Recovery Time-Riker Scale</measure>
      <time_frame>Immediately After extubation</time_frame>
      <description>Sedation and agitation will be assessed immediately after extubation using the Riker Sedation-Agitation Scale (SAS) which is on scale of 1-7 with 1 being the most favorable (easier to rouse/calm but responsive) and 7 being the least favorable (deeply sedated/higher agitation).</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Emergent Delirium and Recovery Time-Richmond Scale</measure>
      <time_frame>Immediately After extubation</time_frame>
      <description>Sedation and agitation will be assessed immediately after extubation using a second scale known as the Richmond Agitation-Sedation Scale (RASS). The RASS is on a scale of -5 to +4, with higher/more positive scores indicating worse outcomes (aka more aggressive behavior) and lower scores indicating better outcomes (less responsiveness). A score of 0(Zero) indicates a calm but alert patient.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Post-operative pain or complications</measure>
      <time_frame>0-1 hour post-operative</time_frame>
      <description>Patients will recover for 1 hour in the post-anesthesia care unit, and a well-trained nurse blinded to the randomized study group will evaluate pain intensity by using the numeric rating scale (0-10 range, with higher scores indicating worse pain) at three intervals: immediately after arrival, 30 minutes after arrival, and 60 minutes after arrival. Any rescue analgesics that are administered will be documented. Patients will be observed postoperatively for any adverse events, as is standard procedure. Any other adverse features such as nausea, vomiting, or changes in vision or color will be followed for 30 days post procedure.</description>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">100</enrollment>
    <condition>Perforated Eardrum</condition>
    <arm_group>
      <arm_group_label>Inhalational Anesthesia</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>Adults:&#xD;
  The control group will receive general inhalational anesthesia (sevoflurane, isoflurane). The will be induced with fentanyl 1-2µg/kg, propofol 2mg/kg, lidocaine 1mg/kg. After orotracheal intubation, anesthesia will be maintained with isoflurane 1.5-2% or sevoflurane 1-2%.&#xD;
  Children (12 or younger) induced with a combination of volatile anesthetic gases, including sevoflurane (up to 8%) and nitrous oxide gas (up to 70%). Those who are older than 12 will have an intravenous line placed in the preoperative area and as such will be induced with remifentanil and propofol as above. For maintenance, children in the control arm will receive 0.6 - 1.5% sevoflurane.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Total Intravenous Anesthesia (TIVA)</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>Adults:&#xD;
  The comparator arm will receive total intravenous anesthesia (propofol and remifentanil). They will be induced with fentanyl 1-2µg/kg, propofol 2mg/kg, and lidocaine 1mg/kg. After orotracheal intubation, anesthesia will be maintained with propofol 100-200mcg/kg/min, remifentanil 0.05-2µg/kg/min.&#xD;
  Children (12 or younger) induced with a combination of volatile anesthetic gases, including sevoflurane (up to 8%) and nitrous oxide gas (up to 70%). Those who are older than 12 will have an intravenous line placed in the preoperative area and as such will be induced with remifentanil and propofol as above. For maintenance, they will receive 100-200mcg/min propofol and 0.05-2µg/kg/min remifentanil.</description>
    </arm_group>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Isoflurane Inhalant Product</intervention_name>
      <description>1.5-2%</description>
      <arm_group_label>Inhalational Anesthesia</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Sevoflurane inhalant product</intervention_name>
      <description>1-2% adults 0.6-1.5% Children</description>
      <arm_group_label>Inhalational Anesthesia</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Propofol injection</intervention_name>
      <description>1mg/kg-mcg/kg/min adults 100-200mcg/kg/min children</description>
      <arm_group_label>Total Intravenous Anesthesia (TIVA)</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Remifentanil Injection</intervention_name>
      <description>0.05-2ug/kg/min adults and children</description>
      <arm_group_label>Total Intravenous Anesthesia (TIVA)</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Individuals of all ages&#xD;
  &#xD;
            -  Scheduled to undergo an endoscopic tympanoplasty&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Individuals with anticoagulation disorders&#xD;
  &#xD;
            -  Those receiving anticoagulation therapy currently&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>0 Years</minimum_age>
      <maximum_age>100 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Rahul Mehta, MD</last_name>
      <role>Principal Investigator</role>
      <affiliation>Our Lady of the Lake Hospital</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Leslie S Son, PhD</last_name>
      <phone>225-765-7659</phone>
      <email>Lson@lsuhsc.edu</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Christine LeBoeuf, DNP</last_name>
      <phone>225-765-7659</phone>
      <email>christine.leboeuf@fmolhs.org</email>
    </overall_contact_backup>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>July 20, 2023</study_first_submitted>
    <study_first_submitted_qc>August 7, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 15, 2023</study_first_posted>
    <last_update_submitted>August 17, 2023</last_update_submitted>
    <last_update_submitted_qc>August 17, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 21, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Our Lady of the Lake Hospital</investigator_affiliation>
      <investigator_full_name>Leslie Son</investigator_full_name>
      <investigator_title>Research Scientist-Study Coordinator</investigator_title>
    </responsible_party>
    <keyword>tympanoplasty</keyword>
    <keyword>Inhalational anesthesia</keyword>
    <keyword>total intravenous anesthesia</keyword>
    <keyword>intraoperative blood loss</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Tympanic Membrane Perforation</mesh_term>
    </condition_browse>
    <intervention_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Remifentanil</mesh_term>
      <mesh_term>Propofol</mesh_term>
      <mesh_term>Sevoflurane</mesh_term>
      <mesh_term>Isoflurane</mesh_term>
    </intervention_browse>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT05993039
  org study id: TIVA in Ear Surgery
  nct id: NCT05993039
  lead sponsor: 
  collaborator: 
  has dmc: No
  is fda regulated drug: Yes
  is fda regulated device: No
  is us export: No
  This study aims to prospectively compare surgical field quality and intraoperative blood loss
        between general inhalational anesthesia to total intravenous anesthesia (TIVA) alone in
        subjects undergoing endoscopic ear surgery. A secondary objective is to compare rates of
        emergence delirium and total recovery time between the two groups.
  In sinus surgery, TIVA has been described as a possible advantage in the use of endoscopic
        ear surgery. However, to date, there are no studies that examine blood loss, surgical field
        quality, and recovery in TIVA compared to inhalational anesthesia in the setting of
        endoscopic ear surgery. The hypothesis is that in patients who undergo endoscopic
        tympanoplasty, those who receive TIVA will have reduced intraoperative blood loss, improved
        surgical field quality, and reduced emergence agitation than those who receive inhalational
        anesthesia. This study will be a prospective double-blinded randomized control trial
        consisting of subjects undergoing endoscopic tympanoplasty surgery to assess intraoperative
        blood loss, surgical field quality, rates of emergence delirium, and recovery time.
  allocation: Randomized
  intervention model: Parallel Assignment
  intervention model description: double-blinded randomized control
  primary purpose: Treatment
  masking: Double (Participant, Care Provider)
  masking description: In the operating room, in order to blind the surgeon to the type of anesthesia used, a surgical drape will be placed in between the subject and the anesthesia team to conceal the anesthesia machinery and equipment. A sham intravenous pole will be at the anesthesia workstation for those subjects in the control arm to contribute to the blinding of the surgeon. Patients will not be informed about which arm they are randomly assigned to and only the anesthesiologist will be aware prior to the surgery.
  measure: Surgical Field Quality
  time frame: Post-Operative evaluation (within 2 weeks)
  description: Neurotologists will evaluate endoscopic video clips from each surgery to assess clarity of field at different points in the surgery using the Boezaart scale grading system. It is a scale from 0-5, with 0 being the most favorable outcome and 5 being the least favorable outcome.
  measure: Intra-operative blood loss
  time frame: 1-2 hours during surgery
  description: Intraoperative blood loss will be determined by measuring the total number of pledgets needed to attain hemostatsis. This will be a general observation with the more pledgets needed to stop bleeding in the surgical area indicates more possible blood loss than the procedures with that require less pledgets.
  measure: Emergent Delirium and Recovery Time-Riker Scale
  time frame: Immediately After extubation
  description: Sedation and agitation will be assessed immediately after extubation using the Riker Sedation-Agitation Scale (SAS) which is on scale of 1-7 with 1 being the most favorable (easier to rouse/calm but responsive) and 7 being the least favorable (deeply sedated/higher agitation).
  measure: Emergent Delirium and Recovery Time-Richmond Scale
  time frame: Immediately After extubation
  description: Sedation and agitation will be assessed immediately after extubation using a second scale known as the Richmond Agitation-Sedation Scale (RASS). The RASS is on a scale of -5 to +4, with higher/more positive scores indicating worse outcomes (aka more aggressive behavior) and lower scores indicating better outcomes (less responsiveness). A score of 0(Zero) indicates a calm but alert patient.
  measure: Post-operative pain or complications
  time frame: 0-1 hour post-operative
  description: Patients will recover for 1 hour in the post-anesthesia care unit, and a well-trained nurse blinded to the randomized study group will evaluate pain intensity by using the numeric rating scale (0-10 range, with higher scores indicating worse pain) at three intervals: immediately after arrival, 30 minutes after arrival, and 60 minutes after arrival. Any rescue analgesics that are administered will be documented. Patients will be observed postoperatively for any adverse events, as is standard procedure. Any other adverse features such as nausea, vomiting, or changes in vision or color will be followed for 30 days post procedure.
  arm group label: Inhalational Anesthesia
  arm group type: Active Comparator
  description: Adults:
  The control group will receive general inhalational anesthesia (sevoflurane, isoflurane). The will be induced with fentanyl 1-2µg/kg, propofol 2mg/kg, lidocaine 1mg/kg. After orotracheal intubation, anesthesia will be maintained with isoflurane 1.5-2% or sevoflurane 1-2%.
  Children (12 or younger) induced with a combination of volatile anesthetic gases, including sevoflurane (up to 8%) and nitrous oxide gas (up to 70%). Those who are older than 12 will have an intravenous line placed in the preoperative area and as such will be induced with remifentanil and propofol as above. For maintenance, children in the control arm will receive 0.6 - 1.5% sevoflurane.
  arm group label: Total Intravenous Anesthesia (TIVA)
  arm group type: Active Comparator
  description: Adults:
  The comparator arm will receive total intravenous anesthesia (propofol and remifentanil). They will be induced with fentanyl 1-2µg/kg, propofol 2mg/kg, and lidocaine 1mg/kg. After orotracheal intubation, anesthesia will be maintained with propofol 100-200mcg/kg/min, remifentanil 0.05-2µg/kg/min.
  Children (12 or younger) induced with a combination of volatile anesthetic gases, including sevoflurane (up to 8%) and nitrous oxide gas (up to 70%). Those who are older than 12 will have an intravenous line placed in the preoperative area and as such will be induced with remifentanil and propofol as above. For maintenance, they will receive 100-200mcg/min propofol and 0.05-2µg/kg/min remifentanil.
  intervention type: Drug
  intervention name: Isoflurane Inhalant Product
  description: 1.5-2%
  arm group label: Inhalational Anesthesia
  intervention type: Drug
  intervention name: Sevoflurane inhalant product
  description: 1-2% adults 0.6-1.5% Children
  arm group label: Inhalational Anesthesia
  intervention type: Drug
  intervention name: Propofol injection
  description: 1mg/kg-mcg/kg/min adults 100-200mcg/kg/min children
  arm group label: Total Intravenous Anesthesia (TIVA)
  intervention type: Drug
  intervention name: Remifentanil Injection
  description: 0.05-2ug/kg/min adults and children
  arm group label: Total Intravenous Anesthesia (TIVA)
  criteria: 
  gender: All
  minimum age: 0 Years
  maximum age: 100 Years
  healthy volunteers: No
  last name: Rahul Mehta, MD
  role: Principal Investigator
  affiliation: Our Lady of the Lake Hospital
  last name: Leslie S Son, PhD
  phone: 225-765-7659
  email: Lson@lsuhsc.edu
  last name: Christine LeBoeuf, DNP
  phone: 225-765-7659
  email: christine.leboeuf@fmolhs.org
  responsible party type: Principal Investigator
  investigator affiliation: Our Lady of the Lake Hospital
  investigator full name: Leslie Son
  investigator title: Research Scientist-Study Coordinator
  mesh term: Tympanic Membrane Perforation
  mesh term: Remifentanil
  mesh term: Propofol
  mesh term: Sevoflurane
  mesh term: Isoflurane
  sharing ipd: No