<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/NCT01701960</url>
  </required_header>
  <id_info>
    <org_study_id>5120227</org_study_id>
    <nct_id>NCT01701960</nct_id>
  </id_info>
  <brief_title>Effect of Local Anesthetic on Hemodynamic Measures During Nasal Surgery</brief_title>
  <official_title>Effect of Local Anesthetic on Hemodynamic Measures During Nasal Surgery</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Loma Linda University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Loma Linda University</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      1% Lidocaine with 1:100,000 to 1:200,000 of epinephrine is routinely injected into the nasal&#xD;
      mucosa during nasal surgery to reduce patient blood loss and improve the surgical field and&#xD;
      visibility. Typically 1% lidocaine with 1:100,000 of epinephrine is used in nasal surgery.&#xD;
      However, 1 % lidocaine with 1:200,000 (which is a more dilute solution of epinephrine) is&#xD;
      also used. This latter dose theoretically should have a lesser effect on cardiac stimulation&#xD;
      which increases the heart rate and blood pressure at the time of surgery. The nasal mucosa&#xD;
      has excellent absorbing ability which is great for the application of drugs but there is&#xD;
      concern for systemic absorption and side effects. Potential serious side effects can occur&#xD;
      with local injection such as hypertension, tachycardia, and cardiac arrhythmias. These side&#xD;
      effects occur mainly through the absorption of epinephrine. It is the goal of this study to&#xD;
      see if a weaker concentration of epinephrine (1:200,000) can maintain a good surgical field&#xD;
      with a decrease in hemodynamic side effects.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Objective- To evaluate the effect of 1% lidocaine with 1:200,000 of epinephrine on&#xD;
      hemodynamic measures and bleeding in the surgical field in patients undergoing nasal surgery&#xD;
      compared to 1% lidocaine with 1:100,000.&#xD;
&#xD;
      Recruitment plan- Patients undergoing general anesthetic for nasal surgery (septoplasty or&#xD;
      sinus surgery) will be asked to participate in this study. All patients undergoing nasal&#xD;
      surgery are injected with local anesthetic into the nasal mucosa after induction of general&#xD;
      anesthetic. Those patients who agree to participate in the study will be randomized into 2&#xD;
      groups (injection either 1 % lidocaine with 1:100,000 or 1:200,000 of epinephrine).&#xD;
&#xD;
      Procedures&#xD;
&#xD;
        1. Patients will be put to sleep following standard general anesthetic protocol&#xD;
&#xD;
        2. Patients will be injected with either 1% lidocaine with 1:100,000 or 1% lidocaine with&#xD;
           1:200,000 into the nasal mucosa&#xD;
&#xD;
        3. After injection the following will be measured every 15 minutes for the first hour to&#xD;
           evaluate effectiveness of the local anesthetic.&#xD;
&#xD;
             1. Heart rate&#xD;
&#xD;
             2. Blood pressure&#xD;
&#xD;
             3. Routine ECG monitoring&#xD;
&#xD;
             4. MAP (mean arterial pressure)&#xD;
&#xD;
             5. Surgical field, degree of bleeding.&#xD;
&#xD;
      Alternatives- Subjects can refuse to participate in the study. If subjects refuse to&#xD;
      participate in the study they will still be injected with 1% lidocaine with 1:200,000 of&#xD;
      epinephrine which is standard of care&#xD;
&#xD;
      Data analysis- data will be compiled and statistical analysis will be made using PRISM&#xD;
      software.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Withdrawn</overall_status>
  <why_stopped>
    no time&#xD;
  </why_stopped>
  <start_date>November 2012</start_date>
  <completion_date type="Actual">August 2014</completion_date>
  <primary_completion_date type="Anticipated">February 2014</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>change in blood pressure</measure>
    <time_frame>over the course of surgery</time_frame>
  </primary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Actual">0</enrollment>
  <condition>Heart Rate</condition>
  <condition>Blood Pressure</condition>
  <condition>Blood Loss During Surgery</condition>
  <condition>Surgical Field</condition>
  <arm_group>
    <arm_group_label>Group 1</arm_group_label>
    <description>This cohort will be injected with 1% lidocaine with 1:100,000 of epinephrine into the nasal mucosa at the time of nasal surgery</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Group 2</arm_group_label>
    <description>This group will be injected with 1% lidocaine with 1:200,000 of epinephrine into the nasal mucosa at the start of nasal surgery.</description>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        Subjects ages 16-75 undergoing routine nasal surgery which will include septoplasty and&#xD;
        sinus surgery&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  any patient between the ages of 16-75 who is scheduled to undergo routine nasal&#xD;
             surgery.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  allergy to lidocaine,&#xD;
&#xD;
          -  recent MI,&#xD;
&#xD;
          -  recent stroke,&#xD;
&#xD;
          -  uncontrolled hypertension,&#xD;
&#xD;
          -  arrhythmias,&#xD;
&#xD;
          -  congestive heart failure.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>16 Years</minimum_age>
    <maximum_age>75 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Kristin A Seiberling, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Loma Linda University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Loma Linda University Medical Center</name>
      <address>
        <city>Loma Linda</city>
        <state>California</state>
        <zip>92354</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>March 2015</verification_date>
  <study_first_submitted>October 3, 2012</study_first_submitted>
  <study_first_submitted_qc>October 4, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 5, 2012</study_first_posted>
  <last_update_submitted>March 18, 2015</last_update_submitted>
  <last_update_submitted_qc>March 18, 2015</last_update_submitted_qc>
  <last_update_posted type="Estimate">March 20, 2015</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Loma Linda University</investigator_affiliation>
    <investigator_full_name>Kristin Seiberling, MD</investigator_full_name>
    <investigator_title>Associate Professor</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Hemorrhage</mesh_term>
  </condition_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/NCT01701960
org study id: 5120227
nct id: NCT01701960
lead sponsor: 
has dmc: Yes
1% Lidocaine with 1:100,000 to 1:200,000 of epinephrine is routinely injected into the nasal
      mucosa during nasal surgery to reduce patient blood loss and improve the surgical field and
      visibility. Typically 1% lidocaine with 1:100,000 of epinephrine is used in nasal surgery.
      However, 1 % lidocaine with 1:200,000 (which is a more dilute solution of epinephrine) is
      also used. This latter dose theoretically should have a lesser effect on cardiac stimulation
      which increases the heart rate and blood pressure at the time of surgery. The nasal mucosa
      has excellent absorbing ability which is great for the application of drugs but there is
      concern for systemic absorption and side effects. Potential serious side effects can occur
      with local injection such as hypertension, tachycardia, and cardiac arrhythmias. These side
      effects occur mainly through the absorption of epinephrine. It is the goal of this study to
      see if a weaker concentration of epinephrine (1:200,000) can maintain a good surgical field
      with a decrease in hemodynamic side effects.
Objective- To evaluate the effect of 1% lidocaine with 1:200,000 of epinephrine on
      hemodynamic measures and bleeding in the surgical field in patients undergoing nasal surgery
      compared to 1% lidocaine with 1:100,000.

      Recruitment plan- Patients undergoing general anesthetic for nasal surgery (septoplasty or
      sinus surgery) will be asked to participate in this study. All patients undergoing nasal
      surgery are injected with local anesthetic into the nasal mucosa after induction of general
      anesthetic. Those patients who agree to participate in the study will be randomized into 2
      groups (injection either 1 % lidocaine with 1:100,000 or 1:200,000 of epinephrine).

      Procedures

        1. Patients will be put to sleep following standard general anesthetic protocol

        2. Patients will be injected with either 1% lidocaine with 1:100,000 or 1% lidocaine with
           1:200,000 into the nasal mucosa

        3. After injection the following will be measured every 15 minutes for the first hour to
           evaluate effectiveness of the local anesthetic.

             1. Heart rate

             2. Blood pressure

             3. Routine ECG monitoring

             4. MAP (mean arterial pressure)

             5. Surgical field, degree of bleeding.

      Alternatives- Subjects can refuse to participate in the study. If subjects refuse to
      participate in the study they will still be injected with 1% lidocaine with 1:200,000 of
      epinephrine which is standard of care

      Data analysis- data will be compiled and statistical analysis will be made using PRISM
      software.
observational model: Cohort
time perspective: Prospective
measure: change in blood pressure
time frame: over the course of surgery
arm group label: Group 1
description: This cohort will be injected with 1% lidocaine with 1:100,000 of epinephrine into the nasal mucosa at the time of nasal surgery
arm group label: Group 2
description: This group will be injected with 1% lidocaine with 1:200,000 of epinephrine into the nasal mucosa at the start of nasal surgery.
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 16 Years
maximum age: 75 Years
healthy volunteers: No
last name: Kristin A Seiberling, MD
role: Principal Investigator
affiliation: Loma Linda University
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: Loma Linda University
investigator full name: Kristin Seiberling, MD
investigator title: Associate Professor
mesh term: Hemorrhage