<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/NCT01724983</url>
  </required_header>
  <id_info>
    <org_study_id>KET2271</org_study_id>
    <nct_id>NCT01724983</nct_id>
  </id_info>
  <brief_title>Ketamine in Bariatric Surgery</brief_title>
  <official_title>Effects of Ketamine on Recovery From Bariatric Surgery</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Padova</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Padova</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Ketamine may improve recovery from bariatric surgery.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Active, not recruiting</last_known_status>
  <start_date>June 2012</start_date>
  <completion_date type="Anticipated">June 2014</completion_date>
  <primary_completion_date type="Anticipated">June 2014</primary_completion_date>
  <phase>Phase 3</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>Treatment</primary_purpose>
    <masking>Double (Participant, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>pain level</measure>
    <time_frame>postoperatively, up to 3 months</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>mood level</measure>
    <time_frame>postoperatively, up to 3 months</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>total dosages of analgesic and muscle relaxant drugs</measure>
    <time_frame>postoperatively, up to 3 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>postanesthetic recovery</measure>
    <time_frame>postoperatively, up to 24 hours</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>satisfaction of the patient and of the surgeon</measure>
    <time_frame>day 1</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>pulse oximetry saturation</measure>
    <time_frame>postoperatively, up to 24 hours</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>lung volumes</measure>
    <time_frame>postoperatively, up to 48 hours from end of surgery</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>antihemetic drug dosage</measure>
    <time_frame>postoperatively, up to 24 hours</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>vasoactive drugs</measure>
    <time_frame>intraoperatively and up to 24 hours from surgery end</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">90</enrollment>
  <condition>Morbid Obesity</condition>
  <arm_group>
    <arm_group_label>ketamine</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>patients will receive ketamine at induction</description>
  </arm_group>
  <arm_group>
    <arm_group_label>fentanyl</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>patients will receive fentanyl at induction</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>ketamine</intervention_name>
    <arm_group_label>ketamine</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>fentanyl</intervention_name>
    <arm_group_label>fentanyl</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  age &gt; 18&#xD;
&#xD;
          -  obesity (Body Mass Index &gt; 30)&#xD;
&#xD;
          -  ASA classificazion &lt; 4&#xD;
&#xD;
          -  candidate to bariatric surgery&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  known or presumed pregnancy&#xD;
&#xD;
          -  previous surgery on the airway, esophagus or stomach&#xD;
&#xD;
          -  uncontrolled psychiatric symptomatology&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Ulderico Freo, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Padova</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Azienda Ospedaliera</name>
      <address>
        <city>Padova</city>
        <state>PD</state>
        <zip>35121</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Italy</country>
  </location_countries>
  <verification_date>November 2012</verification_date>
  <study_first_submitted>September 14, 2012</study_first_submitted>
  <study_first_submitted_qc>November 7, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 12, 2012</study_first_posted>
  <last_update_submitted>November 7, 2012</last_update_submitted>
  <last_update_submitted_qc>November 7, 2012</last_update_submitted_qc>
  <last_update_posted type="Estimate">November 12, 2012</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>pain</keyword>
  <keyword>mood</keyword>
  <keyword>depression</keyword>
  <keyword>respiration</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Obesity, Morbid</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Fentanyl</mesh_term>
    <mesh_term>Ketamine</mesh_term>
  </intervention_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/NCT01724983
org study id: KET2271
nct id: NCT01724983
lead sponsor: 
has dmc: No
Ketamine may improve recovery from bariatric surgery.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Participant, Outcomes Assessor)
measure: pain level
time frame: postoperatively, up to 3 months
measure: mood level
time frame: postoperatively, up to 3 months
measure: total dosages of analgesic and muscle relaxant drugs
time frame: postoperatively, up to 3 months
measure: postanesthetic recovery
time frame: postoperatively, up to 24 hours
measure: satisfaction of the patient and of the surgeon
time frame: day 1
measure: pulse oximetry saturation
time frame: postoperatively, up to 24 hours
measure: lung volumes
time frame: postoperatively, up to 48 hours from end of surgery
measure: antihemetic drug dosage
time frame: postoperatively, up to 24 hours
measure: vasoactive drugs
time frame: intraoperatively and up to 24 hours from surgery end
arm group label: ketamine
arm group type: Experimental
description: patients will receive ketamine at induction
arm group label: fentanyl
arm group type: Active Comparator
description: patients will receive fentanyl at induction
intervention type: Drug
intervention name: ketamine
arm group label: ketamine
intervention type: Drug
intervention name: fentanyl
arm group label: fentanyl
criteria: 
gender: All
minimum age: 18 Years
maximum age: 65 Years
healthy volunteers: No
last name: Ulderico Freo, MD
role: Principal Investigator
affiliation: University of Padova
facility: 
country: Italy
responsible party type: Sponsor
mesh term: Obesity, Morbid
mesh term: Fentanyl
mesh term: Ketamine