<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/NCT03256149</url>
  </required_header>
  <id_info>
    <org_study_id>CE 14.247</org_study_id>
    <nct_id>NCT03256149</nct_id>
  </id_info>
  <brief_title>High Dose Steroids for Dysphagia</brief_title>
  <acronym>SHDD</acronym>
  <official_title>Effect of High Dose Steroids on Dysphagia After Anterior Spinal Surgery: a Randomized Controlled Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Centre hospitalier de l'Université de Montréal (CHUM)</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Centre hospitalier de l'Université de Montréal (CHUM)</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>No</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>
      Few existing data currently indicates that anti-inflammatory drugs could help diminish the&#xD;
      local cervical inflammation tough to cause the dysphagia, hoarseness and dyspnea after an&#xD;
      anterior surgical approach to the spine. This study aims to evaluate the effect of high dose&#xD;
      of steroids on dysphagia after an anterior cervical spine procedure. Patients subjected to a&#xD;
      cervical spine surgery through an anterior approach will be randomized to a treatment group&#xD;
      receiving 3 doses of IV dexamethasone (decadron) and a placebo group receiving saline.&#xD;
      Outcome will be measured with dysphagia scales, modified barium swallow and&#xD;
      rhino-pharyngo-laryngoscopy, all done pre and post-operatively. Secondary outcomes involve&#xD;
      neurological condition, pain and fusion rate.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Withdrawn</overall_status>
  <why_stopped>
    Not enough patients recruted&#xD;
  </why_stopped>
  <start_date type="Actual">March 24, 2015</start_date>
  <completion_date type="Anticipated">February 2019</completion_date>
  <primary_completion_date type="Anticipated">November 2018</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Prevention</primary_purpose>
    <masking>Triple (Participant, Care Provider, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Voice evaluation</measure>
    <time_frame>First day post-operatively</time_frame>
    <description>Voice handicap index</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Dysphagia evaluation: MBSimp</measure>
    <time_frame>First day post-operatively</time_frame>
    <description>Modified Barium Swallow with the calculation fof the MBSimp score</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Soft tissue edema</measure>
    <time_frame>First day post-operatively</time_frame>
    <description>Pre-vertebral soft tissue edema on X Ray</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Airway evaluation</measure>
    <time_frame>First day post-operatively</time_frame>
    <description>Rhino-Pharyngo-Laryngoscopy</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Dysphagia evaluation: Rosenbeck</measure>
    <time_frame>First day post-operatively</time_frame>
    <description>Modified Barium Swallow with calculation of the Rosenbeck score</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Hyperreflexia</measure>
    <time_frame>3 months post-operatively</time_frame>
    <description>hyperreflexia assesment using osteotendinous reflexes graded on a 1 to 4 scale</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Fusion rate</measure>
    <time_frame>6 months after surgery</time_frame>
    <description>Cervical spine fusion at site of surgery seen on CT scan</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Pain</measure>
    <time_frame>3 months after surgery</time_frame>
    <description>Subjective neck pain using analog pain scale</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Strenght</measure>
    <time_frame>3 months after surgery</time_frame>
    <description>4 limbs strengh assessment on a 0 to 5 scale</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Crude touch sensation</measure>
    <time_frame>3 months after surgery</time_frame>
    <description>Presence or absence of hypoesthesia in the limbs</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Surgical site infection</measure>
    <time_frame>3 months after surgery</time_frame>
    <description>Presence or absence of superficial or deep surgical site infection</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">0</enrollment>
  <condition>Dysphagia</condition>
  <condition>Cervical Spine Disease</condition>
  <arm_group>
    <arm_group_label>Treatment group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Dexamethasone, 4 mg IV given at 8 hours interval, first dose received at the time of surgery (induction), 3 doses total</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo group</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Saline given at 8 hours interval, first dose received at the time of surgery (induction), 3 doses total</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Dexamethasone</intervention_name>
    <arm_group_label>Treatment group</arm_group_label>
    <other_name>Decradron</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <description>Normal saline (IV placebo)</description>
    <arm_group_label>Placebo group</arm_group_label>
    <other_name>Saline</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Anterior cervical spine surgery&#xD;
&#xD;
          -  Elective surgery&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Takes steroids for any reason&#xD;
&#xD;
          -  Pre-existing condition leading to dysphagia&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Centre Hospitalier de l'Université de Montréal (CHUM)</name>
      <address>
        <city>Montreal</city>
        <state>Quebec</state>
        <zip>H2L4M1</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Canada</country>
  </location_countries>
  <verification_date>December 2022</verification_date>
  <study_first_submitted>August 17, 2017</study_first_submitted>
  <study_first_submitted_qc>August 17, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 21, 2017</study_first_posted>
  <last_update_submitted>December 12, 2022</last_update_submitted>
  <last_update_submitted_qc>December 12, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">December 14, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Spinal Diseases</mesh_term>
    <mesh_term>Deglutition Disorders</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Dexamethasone</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
  </patient_data>
  <!-- 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/NCT03256149
org study id: CE 14.247
nct id: NCT03256149
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
is us export: No
Few existing data currently indicates that anti-inflammatory drugs could help diminish the
      local cervical inflammation tough to cause the dysphagia, hoarseness and dyspnea after an
      anterior surgical approach to the spine. This study aims to evaluate the effect of high dose
      of steroids on dysphagia after an anterior cervical spine procedure. Patients subjected to a
      cervical spine surgery through an anterior approach will be randomized to a treatment group
      receiving 3 doses of IV dexamethasone (decadron) and a placebo group receiving saline.
      Outcome will be measured with dysphagia scales, modified barium swallow and
      rhino-pharyngo-laryngoscopy, all done pre and post-operatively. Secondary outcomes involve
      neurological condition, pain and fusion rate.
allocation: Randomized
intervention model: Single Group Assignment
primary purpose: Prevention
masking: Triple (Participant, Care Provider, Investigator)
measure: Voice evaluation
time frame: First day post-operatively
description: Voice handicap index
measure: Dysphagia evaluation: MBSimp
time frame: First day post-operatively
description: Modified Barium Swallow with the calculation fof the MBSimp score
measure: Soft tissue edema
time frame: First day post-operatively
description: Pre-vertebral soft tissue edema on X Ray
measure: Airway evaluation
time frame: First day post-operatively
description: Rhino-Pharyngo-Laryngoscopy
measure: Dysphagia evaluation: Rosenbeck
time frame: First day post-operatively
description: Modified Barium Swallow with calculation of the Rosenbeck score
measure: Hyperreflexia
time frame: 3 months post-operatively
description: hyperreflexia assesment using osteotendinous reflexes graded on a 1 to 4 scale
measure: Fusion rate
time frame: 6 months after surgery
description: Cervical spine fusion at site of surgery seen on CT scan
measure: Pain
time frame: 3 months after surgery
description: Subjective neck pain using analog pain scale
measure: Strenght
time frame: 3 months after surgery
description: 4 limbs strengh assessment on a 0 to 5 scale
measure: Crude touch sensation
time frame: 3 months after surgery
description: Presence or absence of hypoesthesia in the limbs
measure: Surgical site infection
time frame: 3 months after surgery
description: Presence or absence of superficial or deep surgical site infection
arm group label: Treatment group
arm group type: Experimental
description: Dexamethasone, 4 mg IV given at 8 hours interval, first dose received at the time of surgery (induction), 3 doses total
arm group label: Placebo group
arm group type: Placebo Comparator
description: Saline given at 8 hours interval, first dose received at the time of surgery (induction), 3 doses total
intervention type: Drug
intervention name: Dexamethasone
arm group label: Treatment group
other name: Decradron
intervention type: Drug
intervention name: Placebo
description: Normal saline (IV placebo)
arm group label: Placebo group
other name: Saline
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
facility: 
country: Canada
responsible party type: Sponsor
mesh term: Spinal Diseases
mesh term: Deglutition Disorders
mesh term: Dexamethasone
sharing ipd: Undecided