<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/NCT03024957</url>
  </required_header>
  <id_info>
    <org_study_id>123</org_study_id>
    <nct_id>NCT03024957</nct_id>
  </id_info>
  <brief_title>Effect of Intrathecal Morphine, Dexmedetomidine or Both in Combination to Bupivacaine on Immunity</brief_title>
  <official_title>Effect of Intrathecal Morphine, Dexmedetomidine or Both in Combination to Bupivacaine on Immunity in Patients Undergoing Major Abdominal Cancer Surgeries</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Assiut University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Assiut University</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      this work aims to investigate the effect of intrathecal administration of Morphine,&#xD;
      Dexmedetomidine or both in combination on cellular immunity and cytokine production in&#xD;
      patients undergoing major abdominal cancer surgeries.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Intrathecal (IT) adjuvants prolong the duration of spinal anesthesia and postoperative&#xD;
      analgesia thereby reducing the requirement of postoperative supplemental analgesics. The&#xD;
      incorporation of adjuvants also lowers the overall dose of local anesthetic and hence&#xD;
      associated side effects. Morphine has been used widely to alleviate various types of pain and&#xD;
      to supplement general anesthesia. On the other hand, morphine has been reported to possess&#xD;
      some immunosuppressive effects. Postoperative immunity is also important in conjunction with&#xD;
      defence against malignant tumour. Dexmedetomidine is a highly selective α2 agonist with&#xD;
      analgesia, sedation, anxiolysis, and sympatholysis as its useful pharmacological actions. The&#xD;
      extended analgesic efficacy of IT dexmedetomidine (ITD) in the postoperative period has been&#xD;
      shown in a few clinical studies. In addition, current insights have identified that&#xD;
      dexmedetomidine has a capacity in inhibiting the overproduction of a variety of inflammatory&#xD;
      molecules including TNF-α, IL-1β, and IL-6 in several acute inflammatory animal models.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Active, not recruiting</last_known_status>
  <start_date>January 2017</start_date>
  <completion_date type="Anticipated">February 2021</completion_date>
  <primary_completion_date type="Actual">September 2018</primary_completion_date>
  <phase>Phase 1/Phase 2</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 (Care Provider, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change from the base line in cellular immunity</measure>
    <time_frame>Baseline , immediate postoperative, 4 hours postoperative and 24 hours postoperative</time_frame>
    <description>CD3, CD4, CD4/CD8, CD16, CD56</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change from baseline in Cytokines</measure>
    <time_frame>Baseline, immediate postoperative, 4 hours postoperative and 24 hours postoperative</time_frame>
    <description>interleukin-1B, interleukin-6, interleukin-10 and tumor necrosis factor</description>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Anticipated">30</enrollment>
  <condition>Immune System Suppression</condition>
  <arm_group>
    <arm_group_label>Dexmedetomidine group</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>patients received 10 mg of hyperbaric bupivacaine 0.5% in 2 mL volume and 5 μg of dexmedetomidine in 1 mL volume intrathecally.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Morphine group</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>patients received 10 mg of hyperbaric bupivacaine 0.5% in 2 mL volume and 0.5 mg morphine sulphate in 1 mL volume intrathecally.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Dexmedetomidine + morphine group</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>patients received 10 mg of hyperbaric bupivacaine 0.5% in 2 mL volume and 5 μg of dexmedetomidine plus 0.5 mg of morphine sulphate in 1 mL volume intrathecally.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Morphine Sulfate</intervention_name>
    <description>Intrathecal injection as the patients will be placed in the sitting position and a 25-gauge Quincke needle will be placed in the L2-3 or L3-4 interspaces with injection of morphine sulphate .</description>
    <arm_group_label>Dexmedetomidine + morphine group</arm_group_label>
    <arm_group_label>Morphine group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Dexmedetomidine</intervention_name>
    <description>Intrathecal injection as the patients will be placed in the sitting position and a 25-gauge Quincke needle will be placed in the L2-3 or L3-4 interspaces.</description>
    <arm_group_label>Dexmedetomidine + morphine group</arm_group_label>
    <arm_group_label>Dexmedetomidine group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Bupivacaine</intervention_name>
    <description>Intrathecal injection as the patients will be placed in the sitting position and a 25-gauge Quincke needle will be placed in the L2-3 or L3-4 interspaces.</description>
    <arm_group_label>Dexmedetomidine + morphine group</arm_group_label>
    <arm_group_label>Dexmedetomidine group</arm_group_label>
    <arm_group_label>Morphine group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  ASA I-II patients scheduled for major abdominal cancer surgeries&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  patients with known allergy to the study drugs,&#xD;
&#xD;
          -  significant cardiac, respiratory, renal or hepatic disease,&#xD;
&#xD;
          -  drug or alcohol abuse,&#xD;
&#xD;
          -  psychiatric illness that would interfere with perception and assessment of pain.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>70 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Assiut University</name>
      <address>
        <city>Assiut</city>
        <zip>171516</zip>
        <country>Egypt</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Egypt</country>
  </location_countries>
  <verification_date>January 2021</verification_date>
  <study_first_submitted>January 11, 2017</study_first_submitted>
  <study_first_submitted_qc>January 18, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 19, 2017</study_first_posted>
  <last_update_submitted>January 13, 2021</last_update_submitted>
  <last_update_submitted_qc>January 13, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">January 14, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Assiut University</investigator_affiliation>
    <investigator_full_name>Shereen Mamdouh</investigator_full_name>
    <investigator_title>Lecturer of anesthesia, ICU and pain managment</investigator_title>
  </responsible_party>
  <keyword>morphine</keyword>
  <keyword>dexmedetomidine</keyword>
  <keyword>immune system</keyword>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Dexmedetomidine</mesh_term>
    <mesh_term>Morphine</mesh_term>
    <mesh_term>Bupivacaine</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/NCT03024957
org study id: 123
nct id: NCT03024957
lead sponsor: 
has dmc: No
this work aims to investigate the effect of intrathecal administration of Morphine,
      Dexmedetomidine or both in combination on cellular immunity and cytokine production in
      patients undergoing major abdominal cancer surgeries.
Intrathecal (IT) adjuvants prolong the duration of spinal anesthesia and postoperative
      analgesia thereby reducing the requirement of postoperative supplemental analgesics. The
      incorporation of adjuvants also lowers the overall dose of local anesthetic and hence
      associated side effects. Morphine has been used widely to alleviate various types of pain and
      to supplement general anesthesia. On the other hand, morphine has been reported to possess
      some immunosuppressive effects. Postoperative immunity is also important in conjunction with
      defence against malignant tumour. Dexmedetomidine is a highly selective α2 agonist with
      analgesia, sedation, anxiolysis, and sympatholysis as its useful pharmacological actions. The
      extended analgesic efficacy of IT dexmedetomidine (ITD) in the postoperative period has been
      shown in a few clinical studies. In addition, current insights have identified that
      dexmedetomidine has a capacity in inhibiting the overproduction of a variety of inflammatory
      molecules including TNF-α, IL-1β, and IL-6 in several acute inflammatory animal models.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Care Provider, Outcomes Assessor)
measure: Change from the base line in cellular immunity
time frame: Baseline , immediate postoperative, 4 hours postoperative and 24 hours postoperative
description: CD3, CD4, CD4/CD8, CD16, CD56
measure: Change from baseline in Cytokines
time frame: Baseline, immediate postoperative, 4 hours postoperative and 24 hours postoperative
description: interleukin-1B, interleukin-6, interleukin-10 and tumor necrosis factor
arm group label: Dexmedetomidine group
arm group type: Active Comparator
description: patients received 10 mg of hyperbaric bupivacaine 0.5% in 2 mL volume and 5 μg of dexmedetomidine in 1 mL volume intrathecally.
arm group label: Morphine group
arm group type: Active Comparator
description: patients received 10 mg of hyperbaric bupivacaine 0.5% in 2 mL volume and 0.5 mg morphine sulphate in 1 mL volume intrathecally.
arm group label: Dexmedetomidine + morphine group
arm group type: Active Comparator
description: patients received 10 mg of hyperbaric bupivacaine 0.5% in 2 mL volume and 5 μg of dexmedetomidine plus 0.5 mg of morphine sulphate in 1 mL volume intrathecally.
intervention type: Drug
intervention name: Morphine Sulfate
description: Intrathecal injection as the patients will be placed in the sitting position and a 25-gauge Quincke needle will be placed in the L2-3 or L3-4 interspaces with injection of morphine sulphate .
arm group label: Dexmedetomidine + morphine group
arm group label: Morphine group
intervention type: Drug
intervention name: Dexmedetomidine
description: Intrathecal injection as the patients will be placed in the sitting position and a 25-gauge Quincke needle will be placed in the L2-3 or L3-4 interspaces.
arm group label: Dexmedetomidine + morphine group
arm group label: Dexmedetomidine group
intervention type: Drug
intervention name: Bupivacaine
description: Intrathecal injection as the patients will be placed in the sitting position and a 25-gauge Quincke needle will be placed in the L2-3 or L3-4 interspaces.
arm group label: Dexmedetomidine + morphine group
arm group label: Dexmedetomidine group
arm group label: Morphine group
criteria: 
gender: All
minimum age: 20 Years
maximum age: 70 Years
healthy volunteers: No
facility: 
country: Egypt
responsible party type: Principal Investigator
investigator affiliation: Assiut University
investigator full name: Shereen Mamdouh
investigator title: Lecturer of anesthesia, ICU and pain managment
mesh term: Dexmedetomidine
mesh term: Morphine
mesh term: Bupivacaine
sharing ipd: No