<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/NCT02213159</url>
  </required_header>
  <id_info>
    <org_study_id>ANES.CZ.2</org_study_id>
    <nct_id>NCT02213159</nct_id>
  </id_info>
  <brief_title>Dexmedetomidine for Postoperative Analgesia After Bariatric Surgery</brief_title>
  <official_title>Intraoperative Dexmedetomidine Versus Morphine for Postoperative Analgesia After Laparoscopic Bariatric Surgery</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>American University of Beirut Medical Center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>American University of Beirut Medical Center</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to determine if Dexmedetomidine given at the end of surgery will&#xD;
      reduce postoperative morphine consumption and improve postoperative quality of recovery as&#xD;
      compared to morphine in patients undergoing laparoscopic bariatric surgery.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      effect of Dexmedetomidine bolus on postoperative morphine requirements&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>July 2014</start_date>
  <completion_date type="Actual">December 2015</completion_date>
  <primary_completion_date type="Actual">November 2015</primary_completion_date>
  <phase>Phase 2/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>Total dose of morphine consumed in Post Anesthesia Care Unit (PACU)</measure>
    <time_frame>At discharge from the PACU</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Time to first morphine requirement in PACU</measure>
    <time_frame>in the PACU</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Numeric Rating Scale (NRS) for Pain</measure>
    <time_frame>in the PACU and at 24 hours</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>NRS for nausea</measure>
    <time_frame>in the PACU</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>incidence of pruritus</measure>
    <time_frame>in the PACU</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>incidence of vomiting or retching</measure>
    <time_frame>in the PACU</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>incidence of respiratory complications</measure>
    <time_frame>in the PACU</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>time to discharge readiness in PACU</measure>
    <time_frame>in the PACU</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>total morphine consumption at 24 hours</measure>
    <time_frame>at 24 hours</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Quality of Recovery (QoR-40) score at 24 hours</measure>
    <time_frame>at 24 hours</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>overall satisfaction at one month</measure>
    <time_frame>one month after surgery</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">60</enrollment>
  <condition>Obesity</condition>
  <condition>Sleep Apnea</condition>
  <condition>Diabetes</condition>
  <condition>Hypertension</condition>
  <arm_group>
    <arm_group_label>Dexmedetomidine</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>prior to anticipated end of surgery bolus of 1 microgram/kg Dexmedetomidine intravenously over 10 minutes followed by 0.5 micrograms/kilogram/hour intravenous infusion until removal of laparoscopes</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Morphine</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>prior to anticipated completion of surgery morphine 0.08 mg/kilogram intravenous bolus over 10 minutes followed by a saline infusion until removal of the laparoscopes</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Dexmedetomidine</intervention_name>
    <arm_group_label>Dexmedetomidine</arm_group_label>
    <other_name>Precedex</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Morphine</intervention_name>
    <arm_group_label>Morphine</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Body Mass Index &gt; 40 kg/m2 or BMI &gt; 35 kg/m2 with comorbid conditions such as&#xD;
             hypertension, diabetes or sleep apnea&#xD;
&#xD;
          -  American Society of Anesthesiologists class I or II&#xD;
&#xD;
          -  Undergoing laparoscopic sleeve gastrectomy bariatric surgery&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Allergy to morphine or its derivatives&#xD;
&#xD;
          -  Allergy to α-2 adrenergic agonists&#xD;
&#xD;
          -  weight over 180 kg&#xD;
&#xD;
          -  history of uncontrolled hypertension&#xD;
&#xD;
          -  heart block greater than first degree&#xD;
&#xD;
          -  prolonged QT interval&#xD;
&#xD;
          -  clinically significant neurologic, cardiovascular, renal, hepatic, or gastrointestinal&#xD;
             diseases&#xD;
&#xD;
          -  received an opioid analgesic medication within a 24 h period prior to surgery&#xD;
&#xD;
          -  history of alcohol, drug abuse or chronic opioid intake&#xD;
&#xD;
          -  history of psychiatric disorder&#xD;
&#xD;
          -  pregnant or breastfeeding.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>70 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Carine Zeeni, M.D.</last_name>
    <role>Principal Investigator</role>
    <affiliation>AUBMC</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Sahar Siddik, M.D.</last_name>
    <role>Principal Investigator</role>
    <affiliation>AUBMC</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>American University of Beirut Medical Center</name>
      <address>
        <city>Beirut</city>
        <country>Lebanon</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Lebanon</country>
  </location_countries>
  <verification_date>January 2016</verification_date>
  <study_first_submitted>August 8, 2014</study_first_submitted>
  <study_first_submitted_qc>August 8, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 11, 2014</study_first_posted>
  <last_update_submitted>July 12, 2016</last_update_submitted>
  <last_update_submitted_qc>July 12, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">July 13, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Dexmedetomidine</keyword>
  <keyword>bariatric surgery</keyword>
  <keyword>postoperative pain</keyword>
  <keyword>morphine consumption</keyword>
  <keyword>Quality of recovery</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Hypertension</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Dexmedetomidine</mesh_term>
    <mesh_term>Morphine</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>No</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/NCT02213159
org study id: ANES.CZ.2
nct id: NCT02213159
lead sponsor: 
has dmc: No
The purpose of this study is to determine if Dexmedetomidine given at the end of surgery will
      reduce postoperative morphine consumption and improve postoperative quality of recovery as
      compared to morphine in patients undergoing laparoscopic bariatric surgery.
effect of Dexmedetomidine bolus on postoperative morphine requirements
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Participant, Outcomes Assessor)
measure: Total dose of morphine consumed in Post Anesthesia Care Unit (PACU)
time frame: At discharge from the PACU
measure: Time to first morphine requirement in PACU
time frame: in the PACU
measure: Numeric Rating Scale (NRS) for Pain
time frame: in the PACU and at 24 hours
measure: NRS for nausea
time frame: in the PACU
measure: incidence of pruritus
time frame: in the PACU
measure: incidence of vomiting or retching
time frame: in the PACU
measure: incidence of respiratory complications
time frame: in the PACU
measure: time to discharge readiness in PACU
time frame: in the PACU
measure: total morphine consumption at 24 hours
time frame: at 24 hours
measure: Quality of Recovery (QoR-40) score at 24 hours
time frame: at 24 hours
measure: overall satisfaction at one month
time frame: one month after surgery
arm group label: Dexmedetomidine
arm group type: Active Comparator
description: prior to anticipated end of surgery bolus of 1 microgram/kg Dexmedetomidine intravenously over 10 minutes followed by 0.5 micrograms/kilogram/hour intravenous infusion until removal of laparoscopes
arm group label: Morphine
arm group type: Active Comparator
description: prior to anticipated completion of surgery morphine 0.08 mg/kilogram intravenous bolus over 10 minutes followed by a saline infusion until removal of the laparoscopes
intervention type: Drug
intervention name: Dexmedetomidine
arm group label: Dexmedetomidine
other name: Precedex
intervention type: Drug
intervention name: Morphine
arm group label: Morphine
criteria: 
gender: All
minimum age: 18 Years
maximum age: 70 Years
healthy volunteers: No
last name: Carine Zeeni, M.D.
role: Principal Investigator
affiliation: AUBMC
last name: Sahar Siddik, M.D.
role: Principal Investigator
affiliation: AUBMC
facility: 
country: Lebanon
responsible party type: Sponsor
mesh term: Hypertension
mesh term: Dexmedetomidine
mesh term: Morphine
sharing ipd: No