<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/NCT01690806</url>
  </required_header>
  <id_info>
    <org_study_id>OTO: OTO12-0447R</org_study_id>
    <nct_id>NCT01690806</nct_id>
  </id_info>
  <brief_title>Dexamethasone for the Prevention of Recurrent Laryngeal Nerve Palsy</brief_title>
  <official_title>Dexamethasone for the Prevention of Recurrent Laryngeal Nerve Palsy (and Not Only) After Thyroid Surgery. A Randomized Double-blind Placebo-controlled Trial.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Università degli Studi dell'Aquila</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Università degli Studi dell'Aquila</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Recurrent laryngeal nerve dysfunction and hypoparathyroidism are well-recognized important&#xD;
      complications of thyroid surgery. The duration of convalescence, after non complicated&#xD;
      thyroid operation, may depend on several factors of which pain and fatigue are the most&#xD;
      important. Nausea and vomiting occur mainly on the day of operation. Glucocorticoids are well&#xD;
      known for their analgesic, anti-inflammatory, immune modulating and antiemetic effects. The&#xD;
      investigators therefore undertook the present study to investigate whether preoperative&#xD;
      dexamethasone could improve surgical outcome in patients undergoing thyroid surgery.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>January 2008</start_date>
  <completion_date type="Actual">March 2012</completion_date>
  <primary_completion_date type="Actual">January 2012</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Control</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Actual">328</enrollment>
  <condition>Benign Neoplasm of Thyroid Gland</condition>
  <condition>Malignant Neoplasm of Thyroid</condition>
  <arm_group>
    <arm_group_label>dexamethasone</arm_group_label>
    <description>Patients who receive dexamethasone (8 mg; Decadron; Merck Sharp &amp; Dohme) intravenously 90 min before skin incision</description>
  </arm_group>
  <arm_group>
    <arm_group_label>placebo</arm_group_label>
    <description>Patients who receive saline placebo intravenously 90 min before skin incision</description>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        patients undergoing thyroid surgery for benign and malignant thyroidal disease&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  patients undergoing thyroid surgery&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  ASA physical class III or IV&#xD;
&#xD;
          -  age &gt; 75 years&#xD;
&#xD;
          -  pregnancy&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>75 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Emanuela M CECILIA, M.D.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Università degli Studi dell'Aquila</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>ospedale San Salvatore-Reparto di Chirurgia Generale Universitaria</name>
      <address>
        <city>L'Aquila</city>
        <state>AQ</state>
        <zip>67100</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Italy</country>
  </location_countries>
  <verification_date>August 2011</verification_date>
  <study_first_submitted>September 19, 2012</study_first_submitted>
  <study_first_submitted_qc>September 21, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 24, 2012</study_first_posted>
  <last_update_submitted>September 25, 2012</last_update_submitted>
  <last_update_submitted_qc>September 25, 2012</last_update_submitted_qc>
  <last_update_posted type="Estimate">September 26, 2012</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Università degli Studi dell'Aquila</investigator_affiliation>
    <investigator_full_name>CECILIA Emanuela Marina</investigator_full_name>
    <investigator_title>M.D.</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Neoplasms</mesh_term>
    <mesh_term>Thyroid Neoplasms</mesh_term>
    <mesh_term>Vocal Cord Paralysis</mesh_term>
    <mesh_term>Thyroid Diseases</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/NCT01690806
org study id: OTO: OTO12-0447R
nct id: NCT01690806
lead sponsor: 
has dmc: Yes
Recurrent laryngeal nerve dysfunction and hypoparathyroidism are well-recognized important
      complications of thyroid surgery. The duration of convalescence, after non complicated
      thyroid operation, may depend on several factors of which pain and fatigue are the most
      important. Nausea and vomiting occur mainly on the day of operation. Glucocorticoids are well
      known for their analgesic, anti-inflammatory, immune modulating and antiemetic effects. The
      investigators therefore undertook the present study to investigate whether preoperative
      dexamethasone could improve surgical outcome in patients undergoing thyroid surgery.
observational model: Case-Control
time perspective: Prospective
arm group label: dexamethasone
description: Patients who receive dexamethasone (8 mg; Decadron; Merck Sharp & Dohme) intravenously 90 min before skin incision
arm group label: placebo
description: Patients who receive saline placebo intravenously 90 min before skin incision
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: N/A
maximum age: 75 Years
healthy volunteers: No
last name: Emanuela M CECILIA, M.D.
role: Principal Investigator
affiliation: Università degli Studi dell'Aquila
facility: 
country: Italy
responsible party type: Principal Investigator
investigator affiliation: Università degli Studi dell'Aquila
investigator full name: CECILIA Emanuela Marina
investigator title: M.D.
mesh term: Neoplasms
mesh term: Thyroid Neoplasms
mesh term: Vocal Cord Paralysis
mesh term: Thyroid Diseases