<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/NCT03006627</url>
  </required_header>
  <id_info>
    <org_study_id>GenderOpioids</org_study_id>
    <nct_id>NCT03006627</nct_id>
  </id_info>
  <brief_title>Gender and Opioid Consumption</brief_title>
  <acronym>GenderOpioid</acronym>
  <sponsors>
    <lead_sponsor>
      <agency>Mansoura University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Mansoura University</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Opioids are widely used for pain relief after major abdominal surgeries[1]. Sex differences&#xD;
      in the opioid analgesia have been reported and investigated in human subjects and animal&#xD;
      models In this study, effects of sex difference on response to opioid analgesics after&#xD;
      abdominal surgeries will be assessed regarding; analgesic duration (primary variable),&#xD;
      frequency of analgesic requirement, total opioid consumption, Opioid related complications&#xD;
      (respiratory depression, Nausea &amp; vomiting, itching, over-sedation, delayed intestinal&#xD;
      motility).&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date>December 2016</start_date>
  <completion_date type="Anticipated">July 2017</completion_date>
  <primary_completion_date type="Anticipated">May 2017</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Single (Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>postoperative morphine consumption</measure>
    <time_frame>24 hours after surgery</time_frame>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">100</enrollment>
  <condition>Postoperative; Parotitis</condition>
  <arm_group>
    <arm_group_label>Male group</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>All male patients scheduled for upper abdominal surgeries</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Female group</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>All female patients scheduled for upper abdominal surgeries</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>postoperative morphine</intervention_name>
    <description>Postoperatively, A loading dose of morphine will be given in incremental doses of 1 mg 5 min apart, till the VAS score reached ≤3. The dose of morphine required to reduce the VAS score to ≤3 will be recorded. Subsequently, PCA pump will be configured to deliver a bolus of 1 mg with a lock-out period lasting for 20 min.</description>
    <arm_group_label>Female group</arm_group_label>
    <arm_group_label>Male group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  ASA I and II Cases scheduled for elective intraabdominal surgeries&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  diabetes,&#xD;
&#xD;
          -  postmenopausal females,&#xD;
&#xD;
          -  laparoscopic surgery,&#xD;
&#xD;
          -  regional anesthesia emergency procedures,&#xD;
&#xD;
          -  sepsis,&#xD;
&#xD;
          -  hepatectomy,&#xD;
&#xD;
          -  Renal impairment, and&#xD;
&#xD;
          -  hepatic impairment,&#xD;
&#xD;
          -  mental and psychiatric disorders.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>45 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <verification_date>December 2016</verification_date>
  <study_first_submitted>December 27, 2016</study_first_submitted>
  <study_first_submitted_qc>December 29, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 30, 2016</study_first_posted>
  <last_update_submitted>December 29, 2016</last_update_submitted>
  <last_update_submitted_qc>December 29, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">December 30, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Mansoura University</investigator_affiliation>
    <investigator_full_name>AlRefaey Kandeel</investigator_full_name>
    <investigator_title>Dr</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Parotitis</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Morphine</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/NCT03006627
org study id: GenderOpioids
nct id: NCT03006627
lead sponsor: 
has dmc: Yes
Opioids are widely used for pain relief after major abdominal surgeries[1]. Sex differences
      in the opioid analgesia have been reported and investigated in human subjects and animal
      models In this study, effects of sex difference on response to opioid analgesics after
      abdominal surgeries will be assessed regarding; analgesic duration (primary variable),
      frequency of analgesic requirement, total opioid consumption, Opioid related complications
      (respiratory depression, Nausea & vomiting, itching, over-sedation, delayed intestinal
      motility).
allocation: Non-Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Outcomes Assessor)
measure: postoperative morphine consumption
time frame: 24 hours after surgery
arm group label: Male group
arm group type: Active Comparator
description: All male patients scheduled for upper abdominal surgeries
arm group label: Female group
arm group type: Active Comparator
description: All female patients scheduled for upper abdominal surgeries
intervention type: Drug
intervention name: postoperative morphine
description: Postoperatively, A loading dose of morphine will be given in incremental doses of 1 mg 5 min apart, till the VAS score reached ≤3. The dose of morphine required to reduce the VAS score to ≤3 will be recorded. Subsequently, PCA pump will be configured to deliver a bolus of 1 mg with a lock-out period lasting for 20 min.
arm group label: Female group
arm group label: Male group
criteria: 
gender: All
minimum age: 18 Years
maximum age: 45 Years
healthy volunteers: No
responsible party type: Principal Investigator
investigator affiliation: Mansoura University
investigator full name: AlRefaey Kandeel
investigator title: Dr
mesh term: Parotitis
mesh term: Morphine
sharing ipd: Undecided