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/NCT06017167</url>
    </required_header>
    <id_info>
      <org_study_id>PONV after lap cholecystectomy</org_study_id>
      <nct_id>NCT06017167</nct_id>
    </id_info>
    <brief_title>Prophylaxis Against Postoperative Nausea and Vomiting After Laparoscopic Cholecystectomy</brief_title>
    <official_title>Dexmedetomidine Versus Dexamethasone Adding to Ondansetron for Prophylaxis Against Postoperative Nausea and Vomiting After Laparoscopic Cholecystectomy</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Tanta University</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Tanta University</source>
    <oversight_info>
      <has_dmc>No</has_dmc>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        The aim of the study is to compare antiemetic effects between dexmedetomidine and ondansteron&#xD;
        in the first group versus dexamethasone and ondansteron in the second group.&#xD;
  &#xD;
        The primary outcome in this study is incidence of postoperative nausea and vomiting after&#xD;
        laparoscopic cholecystectomy.&#xD;
  &#xD;
        The secondary outcomes are:&#xD;
  &#xD;
          -  The severity of post operative nausea and vomiting.&#xD;
  &#xD;
          -  Use of rescue antiemetic drugs.&#xD;
  &#xD;
          -  Postoperative pain and sedation.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        General anesthesia is widely used in several surgeries. It can cause some complications such&#xD;
        as postoperative nausea and vomiting (PONV). PONV is more common in general anesthesia than&#xD;
        spinal anesthesia. PONV remains an extremely significant challenge due to its complex&#xD;
        mechanism, resulting in serious consequences. Therefore an effective way to prevent or arrest&#xD;
        PONV is urgently needed as Also, it can cause electrolyte imbalance and aggravate bleeding&#xD;
        that delay hospital discharge.&#xD;
  &#xD;
        The causes of PONV are multifactorial and can largely be categorized as patient risk factors,&#xD;
        anaesthetic technique, and surgical procedure. Antiemetics work on several different receptor&#xD;
        sites to prevent or treat PONV.&#xD;
  &#xD;
        No single antiemetic pharmaceutical has been provided to be a universal solution to PONV. In&#xD;
        general, multimodal combination treatment has superior viability for PONV prophylaxis&#xD;
        compared with monotherapy .&#xD;
  &#xD;
        Because nausea and vomiting were defined as two separate phe-nomena, studies should report&#xD;
        and evaluate the variables distinctly . While since few patients experience vomiting without&#xD;
        nausea, the incidence of PONV and postoperative nau¬sea (PON) is fairly similar, thus&#xD;
        original papers often do not try to distinguish these variables . So, if PONV but not PON was&#xD;
        reported in trails, we considered the PONV variables as a very close substitute for PON; when&#xD;
        both PONV and PON were reported simultaneously, we assessed the nausea values. The most&#xD;
        com¬monly used time interval to measure the role of antiemetic is 24 hours 6.&#xD;
  &#xD;
        Ondansetron is a serotonin receptor antagonist, which is very important in preventing nausea&#xD;
        and vomiting due to surgery and chemotherapy; it exhibited an anti-vomiting effect by&#xD;
        inhibiting 5-Hydroxytryptamine type 3 (5-HT3) receptors in the vomiting centre .&#xD;
  &#xD;
        Dexmedetomidine is a potent and highly selective a2-adrenoceptor agonist, which binds to&#xD;
        transmembrane G protein-binding receptor located in the brain and spinal cord. Since nausea&#xD;
        and vomit¬ing may be induced by high catecholamine con¬centrations, a decrease of sympathetic&#xD;
        tone could explain the antiemetic effect of dexme¬detomidine. Finally, consumption of&#xD;
        intraopera¬tive opioids, which increases the risk of PONV , may be reduced through the use of&#xD;
        dexmedetomidine It affects the functions of central nervous, circulatory systems and exhibits&#xD;
        sedative, analgesic, sympatholytic properties. Recently, the effect of dexmedetomidine on&#xD;
        PONV has been the focus of clinical researchers. Nevertheless, controversy about the&#xD;
        effectiveness of dexmedetomidine for PONV is still ongoing, for different results reported in&#xD;
        associated literature.&#xD;
  &#xD;
        Glucocorticoids may exert an antiemetic effect by inhibiting inflammatory mediators and by&#xD;
        interacting with serotonin, neurokinin, a-adrenergic receptors, and other receptors.&#xD;
        Furthermore, several studies have shown that dexamethasone enhances the antiemetic efficacies&#xD;
        of 5-hydroxytryptamine type 3 (5-HT3) receptor antagonists.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">September 15, 2022</start_date>
    <completion_date type="Anticipated">October 2023</completion_date>
    <primary_completion_date type="Anticipated">September 2023</primary_completion_date>
    <phase>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>
      <intervention_model_description>Patients will be randomly classified with computer generated random numbers into two equal groups (each group 35 patients) Group I: will receive Ondansetron 4mg + dexmedetomidine 0.5 ug/kg + normal saline to complete 10 ml. volume IV infusion over 10 minutes.&#xD;
  Group II: will receive Ondansetron 4mg + dexamethasone 8mg + normal saline to complete 10 ml volume IV ifusion over 10 minutes.</intervention_model_description>
      <primary_purpose>Treatment</primary_purpose>
      <masking>Double (Participant, Outcomes Assessor)</masking>
      <masking_description>Double (Participant, Outcomes Assessor)&#xD;
  The participants will be kept blind in both groups.&#xD;
  Outcome assessors will be blinded as they will be anesthesia resident and nurse not participating in the study.</masking_description>
    </study_design_info>
    <primary_outcome>
      <measure>The incidence of postoperative nausea and vomiting after laparoscopic cholecystectomy.</measure>
      <time_frame>through out 24 hours after surgery.</time_frame>
      <description>The incidence of vomiting, use of rescue antiemetics, and analgesic requirements were recorded at 0 to 1 hours after surgery in the postanesthetic care unit (PACU)At 6 and 24 hours after surgery, the incidence and severity of PONV were assessed using the Rhodes Index of nausea, vomiting, and retching.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>The severity of post operative nausea and vomiting.</measure>
      <time_frame>During 24 hours after surgery.</time_frame>
      <description>The severity of nausea was evaluated using a 10-point numerical rating scale (NRS) At 6 and 24 hours after surgery, the incidence and severity of PONV were assessed using the Rhodes Index of nausea, vomiting, and reteching.At 6 and 24 hours after surgery.&#xD;
  The Rhodes Index is a reliable and valid patient self-reporting tool to assess nausea, vomiting, and retching and consists of eight items with 5 scales (0-4). This index has been shown to be a highly reliable method for evaluating gastrointestinal distress after ambulatory surgery.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>- Postoperative pain</measure>
      <time_frame>During 24 hours after surgery.</time_frame>
      <description>Pain score was also assessed using a 10-point NRS.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>- Postoperative sedation</measure>
      <time_frame>During 24 hours after surgery.</time_frame>
      <description>Ramsay sedation score (1=agitated, anxious, or restless; 2=oriented, cooperated, and tranquil; 3=responsive to verbal commands only; 4=asleep, brisk response to a loud auditory stimulus or a light glabella tap; 5=sluggish response to a glabella tap or loud auditory stimulus; 6=no response to a loud auditory stimulus or a light glabella tap) were recorded. Over-sedation was defined as a Ramsay sedation score&gt;4.</description>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">70</enrollment>
    <condition>Postoperative Nausea and Vomiting</condition>
    <condition>Laparoscopic Cholecystectomy</condition>
    <arm_group>
      <arm_group_label>Dexmedetomidine Group</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>will receive ondansetron 4mg + dexmedetomidine 0.5 ug/kg + normal saline to complete 10 ml. volume IV infusion over 10 minutes.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Dexamethasone Group</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>will receive Ondansetron 4mg + dexamethasone 8mg + normal saline to complete 10 ml. volume IV infusion over 10 minutes.</description>
    </arm_group>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Ondansetron 4mg + dexmedetomidine 0.5 ug/kg + normal saline .</intervention_name>
      <description>compare antiemetic effects between dexmedetomidine and ondansetron in the first group versus dexamethasone and ondansetron in the second group</description>
      <arm_group_label>Dexmedetomidine Group</arm_group_label>
      <other_name>ondansetron 4mg (Zofran; GlaxoSmithKline, Alexandria, USA</other_name>
      <other_name>dexmedetomidine (Precedex; Ho-Spira Inc., Lake Forest, Illinois, USA</other_name>
    </intervention>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Ondansetron 4mg + dexamethasone 8mg + normal saline.</intervention_name>
      <description>Group II: Ondansetron 4mg + dexamethasone 8mg + normal saline.</description>
      <arm_group_label>Dexamethasone Group</arm_group_label>
      <other_name>ondansetron 4mg (Zofran; GlaxoSmithKline, Alexandria, USA</other_name>
      <other_name>dexamethasone; Amriya Pharmaceutical Industries, Egypt</other_name>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  70 Female patients aged between 18 and 65 years&#xD;
  &#xD;
            -  ASA I or II&#xD;
  &#xD;
            -  patients scheduled for elective laparoscopic cholecystectomy surgery will be included&#xD;
               in this study.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Females above 65 years old.&#xD;
  &#xD;
            -  patients under 18 years old.&#xD;
  &#xD;
            -  ASA &gt; II.&#xD;
  &#xD;
            -  Obesity (BMI&gt;40 kgm2).&#xD;
  &#xD;
            -  Known hypersensitivity to drugs used in the study protocol.&#xD;
  &#xD;
            -  Comorbidities that were known to increase the risk of PONV (e.g. vestibular disease).&#xD;
  &#xD;
            -  Liver or renal dysfunction (liver enzyme or creatinine 1.5 times higher than normal).&#xD;
  &#xD;
            -  Alcoholism or drug abuse.&#xD;
  &#xD;
            -  Use of antiemetics and psychotropic drugs or glucocorticoids within 24 h before&#xD;
               surgery.&#xD;
        </textblock>
      </criteria>
      <gender>Female</gender>
      <gender_based>Yes</gender_based>
      <gender_description>According to APFEL score female is a risk factor for PONV.</gender_description>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>65 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Mohamed A. Lotfy, PHD</last_name>
      <role>Principal Investigator</role>
      <affiliation>Assistant Professor of Anesthesia and Intensive Care, Tanta Univ</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Yasmine M. Eldeba, BA</last_name>
      <phone>0021097732321</phone>
      <email>yasmine162078_pg@med.tanta.edu.eg</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Rehab S. Elkalla, PHD</last_name>
      <phone>01285700765</phone>
      <email>rehab.mohamed@med.tanta.edu.eg</email>
    </overall_contact_backup>
    <location>
      <facility>
        <name>Tanta University hospitals</name>
        <address>
          <city>Tanta</city>
          <state>Algharbia</state>
          <zip>31511</zip>
          <country>Egypt</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Sohair Soliman, professor</last_name>
        <phone>00201283929049</phone>
        <email>sohairsoliman@hotmail.com</email>
      </contact>
      <contact_backup>
        <last_name>Rehab Elkalla, M.D</last_name>
        <phone>01285700765</phone>
        <email>rehab.mohamed@med.tanta.edu.eg</email>
      </contact_backup>
    </location>
    <location_countries>
      <country>Egypt</country>
    </location_countries>
    <reference>
      <citation>Rhodes VA, McDaniel RW. The Index of Nausea, Vomiting, and Retching: a new format of the lndex of Nausea and Vomiting. Oncol Nurs Forum. 1999 Jun;26(5):889-94.</citation>
      <PMID>10382187</PMID>
    </reference>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 14, 2023</study_first_submitted>
    <study_first_submitted_qc>August 26, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 30, 2023</study_first_posted>
    <last_update_submitted>August 26, 2023</last_update_submitted>
    <last_update_submitted_qc>August 26, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 30, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Tanta University</investigator_affiliation>
      <investigator_full_name>yasmine mohammed mahmoud mustafa eldeba</investigator_full_name>
      <investigator_title>Resident doctor of Anaesthesia and ICU Department</investigator_title>
    </responsible_party>
    <keyword>dexamethasone</keyword>
    <keyword>dexmedetomidine</keyword>
    <keyword>ondansetron</keyword>
    <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>Ondansetron</mesh_term>
      <mesh_term>BB 1101</mesh_term>
    </intervention_browse>
    <patient_data>
      <sharing_ipd>Yes</sharing_ipd>
      <ipd_description>The IPD will be available with the principle investigator within 6 months after publishing the study</ipd_description>
      <ipd_info_type>Study Protocol</ipd_info_type>
      <ipd_info_type>Statistical Analysis Plan (SAP)</ipd_info_type>
      <ipd_time_frame>within 6 months after publishing the study</ipd_time_frame>
      <ipd_access_criteria>yasmine162078_pg@med.tanta.edu.eg</ipd_access_criteria>
    </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/NCT06017167
  org study id: PONV after lap cholecystectomy
  nct id: NCT06017167
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  The aim of the study is to compare antiemetic effects between dexmedetomidine and ondansteron
        in the first group versus dexamethasone and ondansteron in the second group.
  
        The primary outcome in this study is incidence of postoperative nausea and vomiting after
        laparoscopic cholecystectomy.
  
        The secondary outcomes are:
  
          -  The severity of post operative nausea and vomiting.
  
          -  Use of rescue antiemetic drugs.
  
          -  Postoperative pain and sedation.
  General anesthesia is widely used in several surgeries. It can cause some complications such
        as postoperative nausea and vomiting (PONV). PONV is more common in general anesthesia than
        spinal anesthesia. PONV remains an extremely significant challenge due to its complex
        mechanism, resulting in serious consequences. Therefore an effective way to prevent or arrest
        PONV is urgently needed as Also, it can cause electrolyte imbalance and aggravate bleeding
        that delay hospital discharge.
  
        The causes of PONV are multifactorial and can largely be categorized as patient risk factors,
        anaesthetic technique, and surgical procedure. Antiemetics work on several different receptor
        sites to prevent or treat PONV.
  
        No single antiemetic pharmaceutical has been provided to be a universal solution to PONV. In
        general, multimodal combination treatment has superior viability for PONV prophylaxis
        compared with monotherapy .
  
        Because nausea and vomiting were defined as two separate phe-nomena, studies should report
        and evaluate the variables distinctly . While since few patients experience vomiting without
        nausea, the incidence of PONV and postoperative nau¬sea (PON) is fairly similar, thus
        original papers often do not try to distinguish these variables . So, if PONV but not PON was
        reported in trails, we considered the PONV variables as a very close substitute for PON; when
        both PONV and PON were reported simultaneously, we assessed the nausea values. The most
        com¬monly used time interval to measure the role of antiemetic is 24 hours 6.
  
        Ondansetron is a serotonin receptor antagonist, which is very important in preventing nausea
        and vomiting due to surgery and chemotherapy; it exhibited an anti-vomiting effect by
        inhibiting 5-Hydroxytryptamine type 3 (5-HT3) receptors in the vomiting centre .
  
        Dexmedetomidine is a potent and highly selective a2-adrenoceptor agonist, which binds to
        transmembrane G protein-binding receptor located in the brain and spinal cord. Since nausea
        and vomit¬ing may be induced by high catecholamine con¬centrations, a decrease of sympathetic
        tone could explain the antiemetic effect of dexme¬detomidine. Finally, consumption of
        intraopera¬tive opioids, which increases the risk of PONV , may be reduced through the use of
        dexmedetomidine It affects the functions of central nervous, circulatory systems and exhibits
        sedative, analgesic, sympatholytic properties. Recently, the effect of dexmedetomidine on
        PONV has been the focus of clinical researchers. Nevertheless, controversy about the
        effectiveness of dexmedetomidine for PONV is still ongoing, for different results reported in
        associated literature.
  
        Glucocorticoids may exert an antiemetic effect by inhibiting inflammatory mediators and by
        interacting with serotonin, neurokinin, a-adrenergic receptors, and other receptors.
        Furthermore, several studies have shown that dexamethasone enhances the antiemetic efficacies
        of 5-hydroxytryptamine type 3 (5-HT3) receptor antagonists.
  allocation: Randomized
  intervention model: Parallel Assignment
  intervention model description: Patients will be randomly classified with computer generated random numbers into two equal groups (each group 35 patients) Group I: will receive Ondansetron 4mg + dexmedetomidine 0.5 ug/kg + normal saline to complete 10 ml. volume IV infusion over 10 minutes.
  Group II: will receive Ondansetron 4mg + dexamethasone 8mg + normal saline to complete 10 ml volume IV ifusion over 10 minutes.
  primary purpose: Treatment
  masking: Double (Participant, Outcomes Assessor)
  masking description: Double (Participant, Outcomes Assessor)
  The participants will be kept blind in both groups.
  Outcome assessors will be blinded as they will be anesthesia resident and nurse not participating in the study.
  measure: The incidence of postoperative nausea and vomiting after laparoscopic cholecystectomy.
  time frame: through out 24 hours after surgery.
  description: The incidence of vomiting, use of rescue antiemetics, and analgesic requirements were recorded at 0 to 1 hours after surgery in the postanesthetic care unit (PACU)At 6 and 24 hours after surgery, the incidence and severity of PONV were assessed using the Rhodes Index of nausea, vomiting, and retching.
  measure: The severity of post operative nausea and vomiting.
  time frame: During 24 hours after surgery.
  description: The severity of nausea was evaluated using a 10-point numerical rating scale (NRS) At 6 and 24 hours after surgery, the incidence and severity of PONV were assessed using the Rhodes Index of nausea, vomiting, and reteching.At 6 and 24 hours after surgery.
  The Rhodes Index is a reliable and valid patient self-reporting tool to assess nausea, vomiting, and retching and consists of eight items with 5 scales (0-4). This index has been shown to be a highly reliable method for evaluating gastrointestinal distress after ambulatory surgery.
  measure: - Postoperative pain
  time frame: During 24 hours after surgery.
  description: Pain score was also assessed using a 10-point NRS.
  measure: - Postoperative sedation
  time frame: During 24 hours after surgery.
  description: Ramsay sedation score (1=agitated, anxious, or restless; 2=oriented, cooperated, and tranquil; 3=responsive to verbal commands only; 4=asleep, brisk response to a loud auditory stimulus or a light glabella tap; 5=sluggish response to a glabella tap or loud auditory stimulus; 6=no response to a loud auditory stimulus or a light glabella tap) were recorded. Over-sedation was defined as a Ramsay sedation score>4.
  arm group label: Dexmedetomidine Group
  arm group type: Active Comparator
  description: will receive ondansetron 4mg + dexmedetomidine 0.5 ug/kg + normal saline to complete 10 ml. volume IV infusion over 10 minutes.
  arm group label: Dexamethasone Group
  arm group type: Active Comparator
  description: will receive Ondansetron 4mg + dexamethasone 8mg + normal saline to complete 10 ml. volume IV infusion over 10 minutes.
  intervention type: Drug
  intervention name: Ondansetron 4mg + dexmedetomidine 0.5 ug/kg + normal saline .
  description: compare antiemetic effects between dexmedetomidine and ondansetron in the first group versus dexamethasone and ondansetron in the second group
  arm group label: Dexmedetomidine Group
  other name: ondansetron 4mg (Zofran; GlaxoSmithKline, Alexandria, USA
  other name: dexmedetomidine (Precedex; Ho-Spira Inc., Lake Forest, Illinois, USA
  intervention type: Drug
  intervention name: Ondansetron 4mg + dexamethasone 8mg + normal saline.
  description: Group II: Ondansetron 4mg + dexamethasone 8mg + normal saline.
  arm group label: Dexamethasone Group
  other name: ondansetron 4mg (Zofran; GlaxoSmithKline, Alexandria, USA
  other name: dexamethasone; Amriya Pharmaceutical Industries, Egypt
  criteria: 
  gender: Female
  gender based: Yes
  gender description: According to APFEL score female is a risk factor for PONV.
  minimum age: 18 Years
  maximum age: 65 Years
  healthy volunteers: No
  last name: Mohamed A. Lotfy, PHD
  role: Principal Investigator
  affiliation: Assistant Professor of Anesthesia and Intensive Care, Tanta Univ
  last name: Yasmine M. Eldeba, BA
  phone: 0021097732321
  email: yasmine162078_pg@med.tanta.edu.eg
  last name: Rehab S. Elkalla, PHD
  phone: 01285700765
  email: rehab.mohamed@med.tanta.edu.eg
  facility: 
  status: Recruiting
  contact: 
  contact backup: 
  country: Egypt
  citation: Rhodes VA, McDaniel RW. The Index of Nausea, Vomiting, and Retching: a new format of the lndex of Nausea and Vomiting. Oncol Nurs Forum. 1999 Jun;26(5):889-94.
  PMID: 10382187
  responsible party type: Principal Investigator
  investigator affiliation: Tanta University
  investigator full name: yasmine mohammed mahmoud mustafa eldeba
  investigator title: Resident doctor of Anaesthesia and ICU Department
  mesh term: Nausea
  mesh term: Vomiting
  mesh term: Postoperative Nausea and Vomiting
  mesh term: Dexamethasone
  mesh term: Dexamethasone acetate
  mesh term: Dexmedetomidine
  mesh term: Ondansetron
  mesh term: BB 1101
  sharing ipd: Yes
  ipd description: The IPD will be available with the principle investigator within 6 months after publishing the study
  ipd info type: Study Protocol
  ipd info type: Statistical Analysis Plan (SAP)
  ipd time frame: within 6 months after publishing the study
  ipd access criteria: yasmine162078_pg@med.tanta.edu.eg