xml: <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/NCT05988671</url>
    </required_header>
    <id_info>
      <org_study_id>RC 10-3-2023</org_study_id>
      <nct_id>NCT05988671</nct_id>
    </id_info>
    <brief_title>Intraperitoneal Dexamethasone, Dexmedetomidine, and Dexamethasone-Dexmedetomidine Combination on Postoperative Nausea and Vomiting After Laparoscopic Cholecystectomy</brief_title>
    <official_title>Comparison of Intraperitoneal Dexamethasone, Dexmedetomidine, and Dexamethasone-Dexmedetomidine Combination on Postoperative Nausea and Vomiting After Laparoscopic Cholecystectomy: A Randomized Clinical Trial</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Al-Azhar University</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
      <collaborator>
        <agency>Benha University</agency>
        <agency_class>Other</agency_class>
      </collaborator>
    </sponsors>
    <source>Al-Azhar University</source>
    <oversight_info>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        Nausea and vomiting are some of the most common complaints of patients after any anesthesia,&#xD;
        which is often associated with postop-erative pain. The double-blind clinical trial study&#xD;
        aimed to compare the prophylactic effect of dexamethasone and dexmedetomidine and their&#xD;
        combination in reducing postoperative nausea and vomiting in patients undergoing laparoscopic&#xD;
        cholecystectomy.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">August 10, 2023</start_date>
    <completion_date type="Anticipated">October 15, 2023</completion_date>
    <primary_completion_date type="Anticipated">October 15, 2023</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>Prevention</primary_purpose>
      <masking>Triple (Participant, Investigator, Outcomes Assessor)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>The number of patients suffered from postoperative nausea and vomiting will be recorded in each group.</measure>
      <time_frame>24 hours postoperative</time_frame>
    </primary_outcome>
    <secondary_outcome>
      <measure>antiemetic consumption</measure>
      <time_frame>24 hours postoperatively</time_frame>
      <description>frequency of antiemetic consumption will be determined</description>
    </secondary_outcome>
    <number_of_arms>4</number_of_arms>
    <enrollment type="Anticipated">120</enrollment>
    <condition>Laparoscopic Cholecystectomy</condition>
    <condition>Postoperative Nausea and Vomiting</condition>
    <arm_group>
      <arm_group_label>Control group</arm_group_label>
      <arm_group_type>Placebo Comparator</arm_group_type>
      <description>received 20 ml normal saline</description>
    </arm_group>
    <arm_group>
      <arm_group_label>dexamethasone group</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>received 8mg dexamethasone</description>
    </arm_group>
    <arm_group>
      <arm_group_label>dexmedetomidine group</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>received dexmedetomidine 1mic/kg</description>
    </arm_group>
    <arm_group>
      <arm_group_label>combined group</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>received combination of both 8mg dexamethasone+ dexmedetomidine 1mic/kg</description>
    </arm_group>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>normal Saline</intervention_name>
      <description>Intraperitoneal route</description>
      <arm_group_label>Control group</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Dexamethasone</intervention_name>
      <description>Intraperitoneal route</description>
      <arm_group_label>dexamethasone group</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Dexmedetomidine</intervention_name>
      <description>Intraperitoneal route</description>
      <arm_group_label>dexmedetomidine group</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Combination of dexamethasone + dexmedetomidine</intervention_name>
      <description>Intraperitoneal route</description>
      <arm_group_label>combined group</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Patients aged from 20 - 50 years&#xD;
  &#xD;
            -  ASA I OR II&#xD;
  &#xD;
            -  undergo laparoscopic cholecystectomy&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Patients with history of psychotic illnesses,&#xD;
  &#xD;
            -  Parkinson's disease&#xD;
  &#xD;
            -  motion disorder&#xD;
  &#xD;
            -  Smoker&#xD;
  &#xD;
            -  or history of chemotherapy&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>20 Years</minimum_age>
      <maximum_age>50 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <location>
      <facility>
        <name>Haney Baumey</name>
        <address>
          <city>Banhā</city>
          <zip>13518</zip>
          <country>Egypt</country>
        </address>
      </facility>
    </location>
    <location>
      <facility>
        <name>Neveen Kohaf</name>
        <address>
          <city>Tanta</city>
          <zip>11865</zip>
          <country>Egypt</country>
        </address>
      </facility>
      <contact>
        <last_name>Neveen Kohaf</last_name>
        <phone>+201060383012</phone>
        <email>nevenabdo@azhar.edu.eg</email>
      </contact>
    </location>
    <location_countries>
      <country>Egypt</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 4, 2023</study_first_submitted>
    <study_first_submitted_qc>August 10, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 14, 2023</study_first_posted>
    <last_update_submitted>August 10, 2023</last_update_submitted>
    <last_update_submitted_qc>August 10, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 14, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Al-Azhar University</investigator_affiliation>
      <investigator_full_name>Neveen Abd El Maksoad Kohaf</investigator_full_name>
      <investigator_title>Lecturer of Clinical Pharmacy</investigator_title>
    </responsible_party>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Nausea</mesh_term>
      <mesh_term>Vomiting</mesh_term>
      <mesh_term>Postoperative Nausea and Vomiting</mesh_term>
    </condition_browse>
    <intervention_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Dexamethasone</mesh_term>
      <mesh_term>Dexamethasone acetate</mesh_term>
      <mesh_term>Dexmedetomidine</mesh_term>
      <mesh_term>BB 1101</mesh_term>
    </intervention_browse>
    <patient_data>
      <sharing_ipd>Yes</sharing_ipd>
      <ipd_description>data could be shared upon reasonable request from principal investigator</ipd_description>
      <ipd_info_type>Study Protocol</ipd_info_type>
      <ipd_info_type>Statistical Analysis Plan (SAP)</ipd_info_type>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT05988671
  org study id: RC 10-3-2023
  nct id: NCT05988671
  lead sponsor: 
  collaborator: 
  is fda regulated drug: No
  is fda regulated device: No
  Nausea and vomiting are some of the most common complaints of patients after any anesthesia,
        which is often associated with postop-erative pain. The double-blind clinical trial study
        aimed to compare the prophylactic effect of dexamethasone and dexmedetomidine and their
        combination in reducing postoperative nausea and vomiting in patients undergoing laparoscopic
        cholecystectomy.
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Prevention
  masking: Triple (Participant, Investigator, Outcomes Assessor)
  measure: The number of patients suffered from postoperative nausea and vomiting will be recorded in each group.
  time frame: 24 hours postoperative
  measure: antiemetic consumption
  time frame: 24 hours postoperatively
  description: frequency of antiemetic consumption will be determined
  arm group label: Control group
  arm group type: Placebo Comparator
  description: received 20 ml normal saline
  arm group label: dexamethasone group
  arm group type: Active Comparator
  description: received 8mg dexamethasone
  arm group label: dexmedetomidine group
  arm group type: Active Comparator
  description: received dexmedetomidine 1mic/kg
  arm group label: combined group
  arm group type: Active Comparator
  description: received combination of both 8mg dexamethasone+ dexmedetomidine 1mic/kg
  intervention type: Drug
  intervention name: normal Saline
  description: Intraperitoneal route
  arm group label: Control group
  intervention type: Drug
  intervention name: Dexamethasone
  description: Intraperitoneal route
  arm group label: dexamethasone group
  intervention type: Drug
  intervention name: Dexmedetomidine
  description: Intraperitoneal route
  arm group label: dexmedetomidine group
  intervention type: Drug
  intervention name: Combination of dexamethasone + dexmedetomidine
  description: Intraperitoneal route
  arm group label: combined group
  criteria: 
  gender: All
  minimum age: 20 Years
  maximum age: 50 Years
  healthy volunteers: No
  facility: 
  facility: 
  contact: 
  country: Egypt
  responsible party type: Principal Investigator
  investigator affiliation: Al-Azhar University
  investigator full name: Neveen Abd El Maksoad Kohaf
  investigator title: Lecturer of Clinical Pharmacy
  mesh term: Nausea
  mesh term: Vomiting
  mesh term: Postoperative Nausea and Vomiting
  mesh term: Dexamethasone
  mesh term: Dexamethasone acetate
  mesh term: Dexmedetomidine
  mesh term: BB 1101
  sharing ipd: Yes
  ipd description: data could be shared upon reasonable request from principal investigator
  ipd info type: Study Protocol
  ipd info type: Statistical Analysis Plan (SAP)