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/NCT06014359</url>
    </required_header>
    <id_info>
      <org_study_id>36264MS150/4/23</org_study_id>
      <nct_id>NCT06014359</nct_id>
    </id_info>
    <brief_title>Preoperative Nebulized Dexmedetomidine on Hemodynamic Changes in Laparoscopic Bariatric Surgery.</brief_title>
    <official_title>Effect of Preoperative Nebulized Dexmedetomidine on Hemodynamic Changes in Morbidly Obese Patients Undergoing Laparoscopic Bariatric Surgery.</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>
        This randomized study aims to evaluate the effect of preoperative dexmedetomidine&#xD;
        nebulization on blunting hemodynamic response for laryngoscope, intubation and&#xD;
        pneumoperitoneum in morbidly obese patients undergoing laparoscopic bariatric surgery.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Dexmedetomidine is an α -2 adrenergic agonist that has been proven to attenuate the&#xD;
        hemodynamic response to intubation and pneumoperitoneum along with dose sparing effect on&#xD;
        opioids and propofol .It has been used in multiple routes such as intravenous, intramuscular,&#xD;
        oral, nasal, or intrathecal routes .Inhalation of nebulized drug is noninvasive and&#xD;
        associated with high bioavailability .Nebulized Dexmedetomidine may offer an attractive&#xD;
        alternative to both intravenous as well as intranasal routes of administration because drug&#xD;
        deposition following nebulization takes place over nasal, buccal, as well as respiratory&#xD;
        mucosa.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Recruiting</overall_status>
    <start_date type="Anticipated">August 27, 2023</start_date>
    <completion_date type="Anticipated">February 1, 2024</completion_date>
    <primary_completion_date type="Anticipated">February 1, 2024</primary_completion_date>
    <phase>N/A</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>Hemodynamic response to laryngoscope, and pneumoperitoneum.</measure>
      <time_frame>Intraoperative</time_frame>
      <description>Heart rate (HR) and non-invasive mean arterial blood pressure (MAP) changes before nebulization, after nebulization, immediately after induction, after intubation at (1-3-6 minutes), post-pneumoperitoneum(T0) then every 15 minutes till end of the surgery.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Degree of sedation</measure>
      <time_frame>Just after nebulization</time_frame>
      <description>Ramsay Sedation Scale).&#xD;
  Awake; agitated or restless or both.&#xD;
  Awake; cooperative, oriented, and tranquil.&#xD;
  Awake but responds to commands only.&#xD;
  Asleep; brisk response to light glabellar tap or loud auditory.&#xD;
  Asleep; sluggish response to light glabellar tap or loud auditory stimulus.&#xD;
  sleep; no response to glabellar tap or loud auditory stimulus.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Amount of opioid consumption</measure>
      <time_frame>24 hours postoperative</time_frame>
      <description>After assessment of pain scores, when NRS measures more than (3), patients will receive 3 mg morphine, which can be repeated considering that the total daily consumption of morphine never exceeds 20 mg.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Amount of fentanyl consumption</measure>
      <time_frame>Intraoperative</time_frame>
      <description>Additional doses of fentanyl (50 mcg) will be given if HR and MAP unexplained increased more than 20% from base line during surgery, and total consumption of fentanyl will be recorded, patients in whom the first attempt of tracheal intubation have failed will be rulled out from the study.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Postoperative pain</measure>
      <time_frame>24 hours postoperative</time_frame>
      <description>Postoperative pain will be measured using numerical rating scale (NRS) where (0 = no pain, 10 = the worst possible pain), postoperative pain will be assessed 30 minutes postoperatively then at ( 2,4,6,12,18,24 hours).</description>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">90</enrollment>
    <condition>Dexmedetomidine</condition>
    <condition>Hemodynamics</condition>
    <condition>Laparoscopic Bariatric Surgery</condition>
    <arm_group>
      <arm_group_label>Control group</arm_group_label>
      <arm_group_type>Placebo Comparator</arm_group_type>
      <description>Patients of this group will be Nebulized with 3 mL of 0.9% saline 15 minutes before shifting the patients to operation room with face mask 6 L/min in sitting position.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Study group</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Patients of this group will be Nebulized with Dexmedetomidine (1 mcg/kg) in 3mL of 0.9% saline 15 minutes before shifting the patients to operation room with face mask 6 L/min in sitting position.</description>
    </arm_group>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Saline</intervention_name>
      <description>Patients will be Nebulized with 3 mL of 0.9% saline 15 minutes before shifting the patients to operation room with face mask 6 L/min in sitting position.</description>
      <arm_group_label>Control group</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Dexmedetomidine</intervention_name>
      <description>Patients will be Nebulized with Dexmedetomidine (1 mcg/kg) in 3mL of 0.9% saline 15 minutes before shifting the patients to operation room with face mask 6 L/min in sitting position.</description>
      <arm_group_label>Study group</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  This study will include 90 adult morbidly obese patients of both sex with BMI (40-50),&#xD;
               (ASA) III physical status, aged between 18 -50 years scheduled for elective&#xD;
               laparoscopic bariatric surgery under general anesthesia.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            1. Patient's refusal.&#xD;
  &#xD;
            2. Decompensated hepatic or renal or cardiac disease.&#xD;
  &#xD;
            3. Expected difficult airway management.&#xD;
  &#xD;
            4. Uncontrolled hypertension.&#xD;
  &#xD;
            5. Psychiatric disease.&#xD;
  &#xD;
            6. Sever pulmonary disorders.&#xD;
  &#xD;
            7. Patients on opioid, alcohol, beta-blockers or allergy to any of the study drugs.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>50 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Abdelhamed I Badreldin, MBBCH</last_name>
      <role>Principal Investigator</role>
      <affiliation>Resident of Anesthesiology, Surgical Intensive Care and Pain Medicine, Faculty of Medicine, Tanta University, Tanta, Egypt.</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Abdelhamed I Badreldin, MBBCH</last_name>
      <phone>00201090690631</phone>
      <email>ai0751294@gmail.com</email>
    </overall_contact>
    <location>
      <facility>
        <name>Tanta University</name>
        <address>
          <city>Tanta</city>
          <state>ElGharbia</state>
          <zip>31527</zip>
          <country>Egypt</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Abdelhamed I Badreldin, MBBCH</last_name>
        <phone>00201090690631</phone>
        <email>ai0751294@gmail.com</email>
      </contact>
      <investigator>
        <last_name>Abdelraheem M Dowidar, MD</last_name>
        <role>Sub-Investigator</role>
      </investigator>
      <investigator>
        <last_name>Naglaa K Mohamed, MD</last_name>
        <role>Sub-Investigator</role>
      </investigator>
      <investigator>
        <last_name>Hend A Ghoneem, MD</last_name>
        <role>Sub-Investigator</role>
      </investigator>
    </location>
    <location_countries>
      <country>Egypt</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 23, 2023</study_first_submitted>
    <study_first_submitted_qc>August 23, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 28, 2023</study_first_posted>
    <last_update_submitted>August 30, 2023</last_update_submitted>
    <last_update_submitted_qc>August 30, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 31, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Tanta University</investigator_affiliation>
      <investigator_full_name>Abdelhamed Ibrahim Abdelhamed Badreldin</investigator_full_name>
      <investigator_title>Resident of Anesthesiology, Surgical Intensive Care and Pain Medicine, Faculty of Medicine, Tanta University, Tanta, Egypt.</investigator_title>
    </responsible_party>
    <intervention_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Dexmedetomidine</mesh_term>
    </intervention_browse>
    <patient_data>
      <sharing_ipd>Yes</sharing_ipd>
      <ipd_description>The data will be available upon a reasonable request from the corresponding author after the end of study for one year.</ipd_description>
      <ipd_info_type>Study Protocol</ipd_info_type>
      <ipd_time_frame>after the end of study for one year.</ipd_time_frame>
      <ipd_access_criteria>The data will be available upon a reasonable request from the corresponding author</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/NCT06014359
  org study id: 36264MS150/4/23
  nct id: NCT06014359
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  This randomized study aims to evaluate the effect of preoperative dexmedetomidine
        nebulization on blunting hemodynamic response for laryngoscope, intubation and
        pneumoperitoneum in morbidly obese patients undergoing laparoscopic bariatric surgery.
  Dexmedetomidine is an α -2 adrenergic agonist that has been proven to attenuate the
        hemodynamic response to intubation and pneumoperitoneum along with dose sparing effect on
        opioids and propofol .It has been used in multiple routes such as intravenous, intramuscular,
        oral, nasal, or intrathecal routes .Inhalation of nebulized drug is noninvasive and
        associated with high bioavailability .Nebulized Dexmedetomidine may offer an attractive
        alternative to both intravenous as well as intranasal routes of administration because drug
        deposition following nebulization takes place over nasal, buccal, as well as respiratory
        mucosa.
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Treatment
  masking: Double (Participant, Outcomes Assessor)
  measure: Hemodynamic response to laryngoscope, and pneumoperitoneum.
  time frame: Intraoperative
  description: Heart rate (HR) and non-invasive mean arterial blood pressure (MAP) changes before nebulization, after nebulization, immediately after induction, after intubation at (1-3-6 minutes), post-pneumoperitoneum(T0) then every 15 minutes till end of the surgery.
  measure: Degree of sedation
  time frame: Just after nebulization
  description: Ramsay Sedation Scale).
  Awake; agitated or restless or both.
  Awake; cooperative, oriented, and tranquil.
  Awake but responds to commands only.
  Asleep; brisk response to light glabellar tap or loud auditory.
  Asleep; sluggish response to light glabellar tap or loud auditory stimulus.
  sleep; no response to glabellar tap or loud auditory stimulus.
  measure: Amount of opioid consumption
  time frame: 24 hours postoperative
  description: After assessment of pain scores, when NRS measures more than (3), patients will receive 3 mg morphine, which can be repeated considering that the total daily consumption of morphine never exceeds 20 mg.
  measure: Amount of fentanyl consumption
  time frame: Intraoperative
  description: Additional doses of fentanyl (50 mcg) will be given if HR and MAP unexplained increased more than 20% from base line during surgery, and total consumption of fentanyl will be recorded, patients in whom the first attempt of tracheal intubation have failed will be rulled out from the study.
  measure: Postoperative pain
  time frame: 24 hours postoperative
  description: Postoperative pain will be measured using numerical rating scale (NRS) where (0 = no pain, 10 = the worst possible pain), postoperative pain will be assessed 30 minutes postoperatively then at ( 2,4,6,12,18,24 hours).
  arm group label: Control group
  arm group type: Placebo Comparator
  description: Patients of this group will be Nebulized with 3 mL of 0.9% saline 15 minutes before shifting the patients to operation room with face mask 6 L/min in sitting position.
  arm group label: Study group
  arm group type: Experimental
  description: Patients of this group will be Nebulized with Dexmedetomidine (1 mcg/kg) in 3mL of 0.9% saline 15 minutes before shifting the patients to operation room with face mask 6 L/min in sitting position.
  intervention type: Drug
  intervention name: Saline
  description: Patients will be Nebulized with 3 mL of 0.9% saline 15 minutes before shifting the patients to operation room with face mask 6 L/min in sitting position.
  arm group label: Control group
  intervention type: Drug
  intervention name: Dexmedetomidine
  description: Patients will be Nebulized with Dexmedetomidine (1 mcg/kg) in 3mL of 0.9% saline 15 minutes before shifting the patients to operation room with face mask 6 L/min in sitting position.
  arm group label: Study group
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 50 Years
  healthy volunteers: No
  last name: Abdelhamed I Badreldin, MBBCH
  role: Principal Investigator
  affiliation: Resident of Anesthesiology, Surgical Intensive Care and Pain Medicine, Faculty of Medicine, Tanta University, Tanta, Egypt.
  last name: Abdelhamed I Badreldin, MBBCH
  phone: 00201090690631
  email: ai0751294@gmail.com
  facility: 
  status: Recruiting
  contact: 
  investigator: 
  investigator: 
  investigator: 
  country: Egypt
  responsible party type: Principal Investigator
  investigator affiliation: Tanta University
  investigator full name: Abdelhamed Ibrahim Abdelhamed Badreldin
  investigator title: Resident of Anesthesiology, Surgical Intensive Care and Pain Medicine, Faculty of Medicine, Tanta University, Tanta, Egypt.
  mesh term: Dexmedetomidine
  sharing ipd: Yes
  ipd description: The data will be available upon a reasonable request from the corresponding author after the end of study for one year.
  ipd info type: Study Protocol
  ipd time frame: after the end of study for one year.
  ipd access criteria: The data will be available upon a reasonable request from the corresponding author