<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/NCT03783676</url>
  </required_header>
  <id_info>
    <org_study_id>18-0415</org_study_id>
    <nct_id>NCT03783676</nct_id>
  </id_info>
  <brief_title>Does Precise Delivery of Remifentanil Decrease Coughing at Emergence From Anesthesia</brief_title>
  <official_title>Does Precise Delivery of Remifentanil Decrease Coughing at Emergence From Anesthesia</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Vermont Medical Center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Vermont Medical Center</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>Yes</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      The investigators want to find a way to reduce or stop patients from coughing at the end of&#xD;
      surgery when the breathing tube is taken out. The breathing tube is removed when the&#xD;
      participants are waking up from anesthesia, and are at the point when the participants can&#xD;
      breathe on your own. In most types of surgery, coughing at this point is common, and does not&#xD;
      affect the participants very much, if at all. But for surgery involving the eye or the head&#xD;
      and neck, coughing right after surgery can cause bleeding at the site of surgery.&#xD;
&#xD;
      This study will use a short-acting pain drug called remifentanil at the end of surgery to&#xD;
      prevent coughing. The investigators will give the participants this medicine for 5 to 30&#xD;
      minutes. The point of the study is to test if using a simple computer program to guide&#xD;
      precise delivery of how much of the drug is given to the participants is effective at&#xD;
      reducing or preventing coughing.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date type="Anticipated">February 15, 2019</start_date>
  <completion_date type="Anticipated">June 2019</completion_date>
  <primary_completion_date type="Anticipated">June 2019</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>Prevention</primary_purpose>
    <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Incidence of cough</measure>
    <time_frame>Measured from surgical end time to patient transfer out of room, approximetly 30 minutes and up to 45 minutes</time_frame>
    <description>Notes presence of cough during emergence</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Coughing grade</measure>
    <time_frame>Measured from surgical end time to patient transfer out of room, approximetly 30 minutes</time_frame>
    <description>Ranks severity of cough during emergence: cough was graded according to the following scoring guidelines: 0=no cough, 1=slight cough, cough without obvious contraction of the abdomen, 2=moderate cough, strong and sudden contraction of the abdomen lasting for less than 5 seconds and 3=severe cough, strong and sudden contraction of the abdomen sustained for more than 5 seconds.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Extubation time</measure>
    <time_frame>Measured from termination of the anesthetic to extubation, approximetly 5 minutes and up to 30 minutes</time_frame>
    <description>Time between the termination of the anesthetic and extubation</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time to recovery</measure>
    <time_frame>Measured from extubation to purposeful movement, approximetly 5 minutes and up to 30 minutes</time_frame>
    <description>Time between extubation and the ability to perform purposeful movement</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">60</enrollment>
  <condition>Cough</condition>
  <arm_group>
    <arm_group_label>Remifentanil group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Will receive remifentanil bolus and infusion guided by an algorithm</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control group</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Will receive normal saline bolus and infusion guided by the remifentanil algorithm</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Remifentanil</intervention_name>
    <description>Receive remifentanil bolus and infusion guided by an algorithm.</description>
    <arm_group_label>Remifentanil group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Normal saline</intervention_name>
    <description>Receive normal saline bolus and infusion guided by the remifentanil algorithm.</description>
    <arm_group_label>Control group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Between the ages of 18 and 80&#xD;
&#xD;
          2. ASA of 1-3&#xD;
&#xD;
          3. Undergoing any of the following elective cases:&#xD;
&#xD;
               1. thyroidectomy (partial or complete)&#xD;
&#xD;
               2. parathyroidectomy&#xD;
&#xD;
               3. ophthalmological surgery&#xD;
&#xD;
          4. Will require endotracheal intubation.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Lean Body Mass &lt; 20 kg,&#xD;
&#xD;
          2. BMI &gt; 45&#xD;
&#xD;
          3. Presence of pulmonary dysfunction&#xD;
&#xD;
          4. Any history of anaphylaxis to remifentanil&#xD;
&#xD;
          5. Requiring the use of total intravenous anesthesia.&#xD;
&#xD;
          6. Per the discretion of the anesthesia provider&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Elie Sarraf, MD.CM.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Resident</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Elie Sarraf, MD.CM.</last_name>
    <phone>(802) 847-4259</phone>
    <email>elie.sarraf@uvmhealth.org</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Alex F Friend</last_name>
    <phone>(802) 847-4259</phone>
    <email>Alexander.Friend@uvmhealth.org</email>
  </overall_contact_backup>
  <verification_date>December 2018</verification_date>
  <study_first_submitted>December 15, 2018</study_first_submitted>
  <study_first_submitted_qc>December 20, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 21, 2018</study_first_posted>
  <last_update_submitted>December 20, 2018</last_update_submitted>
  <last_update_submitted_qc>December 20, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">December 24, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Vermont Medical Center</investigator_affiliation>
    <investigator_full_name>Elie Sarraf</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <keyword>extubation</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Cough</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Remifentanil</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
  </patient_data>
  <provided_document_section>
    <provided_document>
      <document_type>Informed Consent Form</document_type>
      <document_has_protocol>No</document_has_protocol>
      <document_has_icf>Yes</document_has_icf>
      <document_has_sap>No</document_has_sap>
      <document_date>April 10, 2018</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/76/NCT03783676/ICF_000.pdf</document_url>
    </provided_document>
    <provided_document>
      <document_type>Study Protocol</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>No</document_has_sap>
      <document_date>April 10, 2018</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/76/NCT03783676/Prot_001.pdf</document_url>
    </provided_document>
  </provided_document_section>
  <!-- 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/NCT03783676
org study id: 18-0415
nct id: NCT03783676
lead sponsor: 
has dmc: No
is fda regulated drug: Yes
is fda regulated device: No
is us export: Yes
The investigators want to find a way to reduce or stop patients from coughing at the end of
      surgery when the breathing tube is taken out. The breathing tube is removed when the
      participants are waking up from anesthesia, and are at the point when the participants can
      breathe on your own. In most types of surgery, coughing at this point is common, and does not
      affect the participants very much, if at all. But for surgery involving the eye or the head
      and neck, coughing right after surgery can cause bleeding at the site of surgery.

      This study will use a short-acting pain drug called remifentanil at the end of surgery to
      prevent coughing. The investigators will give the participants this medicine for 5 to 30
      minutes. The point of the study is to test if using a simple computer program to guide
      precise delivery of how much of the drug is given to the participants is effective at
      reducing or preventing coughing.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: Incidence of cough
time frame: Measured from surgical end time to patient transfer out of room, approximetly 30 minutes and up to 45 minutes
description: Notes presence of cough during emergence
measure: Coughing grade
time frame: Measured from surgical end time to patient transfer out of room, approximetly 30 minutes
description: Ranks severity of cough during emergence: cough was graded according to the following scoring guidelines: 0=no cough, 1=slight cough, cough without obvious contraction of the abdomen, 2=moderate cough, strong and sudden contraction of the abdomen lasting for less than 5 seconds and 3=severe cough, strong and sudden contraction of the abdomen sustained for more than 5 seconds.
measure: Extubation time
time frame: Measured from termination of the anesthetic to extubation, approximetly 5 minutes and up to 30 minutes
description: Time between the termination of the anesthetic and extubation
measure: Time to recovery
time frame: Measured from extubation to purposeful movement, approximetly 5 minutes and up to 30 minutes
description: Time between extubation and the ability to perform purposeful movement
arm group label: Remifentanil group
arm group type: Experimental
description: Will receive remifentanil bolus and infusion guided by an algorithm
arm group label: Control group
arm group type: Placebo Comparator
description: Will receive normal saline bolus and infusion guided by the remifentanil algorithm
intervention type: Drug
intervention name: Remifentanil
description: Receive remifentanil bolus and infusion guided by an algorithm.
arm group label: Remifentanil group
intervention type: Drug
intervention name: Normal saline
description: Receive normal saline bolus and infusion guided by the remifentanil algorithm.
arm group label: Control group
criteria: 
gender: All
minimum age: 18 Years
maximum age: 80 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Elie Sarraf, MD.CM.
role: Principal Investigator
affiliation: Resident
last name: Elie Sarraf, MD.CM.
phone: (802) 847-4259
email: elie.sarraf@uvmhealth.org
last name: Alex F Friend
phone: (802) 847-4259
email: Alexander.Friend@uvmhealth.org
responsible party type: Principal Investigator
investigator affiliation: University of Vermont Medical Center
investigator full name: Elie Sarraf
investigator title: Principal Investigator
mesh term: Cough
mesh term: Remifentanil
sharing ipd: Undecided
provided document: 
provided document: 