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/NCT06018948</url>
    </required_header>
    <id_info>
      <org_study_id>33360/09/19</org_study_id>
      <nct_id>NCT06018948</nct_id>
    </id_info>
    <brief_title>Effect of Two Different Doses of Dexmedetomidine Infusion in Morbidly Obese Patients</brief_title>
    <official_title>The Effect of Two Different Doses of Dexmedetomidine Infusion on Oxygenation, Lung Mechanics, and Quality of Recovery in Morbidly Obese Patients: A Prospective Randomized Controlled Study</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>Yes</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>
        Compare the effects of two different doses of dexmedetomidine infusion on oxygenation as a&#xD;
        primary outcome and on lung mechanics, quality of recovery and perioperative analgesia as&#xD;
        secondary outcomes in morbidly obese patients with restrictive lung disease undergoing&#xD;
        abdominal surgery.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Dexmedetomidine is a selective α2 receptor agonist and has sympatholytic, analgesic,&#xD;
        anti-inflammatory and sedative properties. Dexmedetomidine decreased dead space and improved&#xD;
        both lung compliance and oxygenation in chronic obstructive pulmonary disease (COPD) patients&#xD;
        undergoing lung cancer surgery.&#xD;
  &#xD;
        The effects of dexmedetomidine on oxygenation and lung mechanics had been investigated in&#xD;
        obstructive lung disease, but there are little information about its effect in morbidly obese&#xD;
        patients with restrictive lung disease .&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Completed</overall_status>
    <start_date type="Actual">September 1, 2019</start_date>
    <completion_date type="Actual">September 30, 2021</completion_date>
    <primary_completion_date type="Actual">September 30, 2021</primary_completion_date>
    <phase>Phase 4</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>Intraoperative oxygenation</measure>
      <time_frame>Intraoperative</time_frame>
      <description>Intraoperative oxygenation was assessed by P/F ratio (Arterial oxygen tension/fraction of inspired oxygen) at baseline and the end of drug infusion.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Dynamic Lung compliance</measure>
      <time_frame>Intraoperative</time_frame>
      <description>Dynamic lung compliance=tidal volume/ (peak airway pressure- Positive end-expiratory pressure).</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Post-operative pain</measure>
      <time_frame>24 hour postoperatively</time_frame>
      <description>Assessment of post-operative pain by The 11-point numeric scale ranges from '0' representing one pain extreme (e.g. &quot;no pain&quot;) to '10' representing the other pain extreme</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Dead space (dead space to tidal volume)</measure>
      <time_frame>Intraoperative</time_frame>
      <description>Physiological dead space was calculated by Hardman and Aitkenhead equation: (dead space to tidal volume) = 1.14(PaCO2 -EtCO2)/PaCO2- 0.005 dead space (%) = dead space by end of infusion - dead space at the base line / dead space by the end of drug infusion %</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Quality of recovery score</measure>
      <time_frame>24 hours Postoperatively</time_frame>
      <description>The Quality of recovery score scale provides a score ranging from 0 to 150, with a high score indicating a good quality of recovery</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Time to first rescue analgesia</measure>
      <time_frame>24 hours Postoperatively</time_frame>
      <description>Time to first rescue analgesia as morphine consumption was recorded</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Static lung compliance</measure>
      <time_frame>Intraoperative</time_frame>
      <description>Static lung compliance =tidal volume /(plateau pressure - Positive end-expiratory pressure).</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Lung compliance</measure>
      <time_frame>24 hours</time_frame>
      <description>compliance = dynamic compliance at the end of the drug infusion - baseline dynamic compliance.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Plateau pressure</measure>
      <time_frame>Intraoperative</time_frame>
      <description>Plateau pressure was calculated by increasing end inspiratory pause to 30-40%.</description>
    </secondary_outcome>
    <number_of_arms>3</number_of_arms>
    <enrollment type="Actual">90</enrollment>
    <condition>Anesthesia</condition>
    <condition>Obesity, Morbid</condition>
    <condition>Dexmedetomidine</condition>
    <arm_group>
      <arm_group_label>Dexmedetomidine 0.6 group</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>patients will receive a bolus dose of 1µg/kg dexmedetomidine15 minute after endotracheal intubation over 10 minutes followed by continuous infusion of 0.6 mic/kg/hour for one hour.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Dexmedetomidine 0.3group</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>patients will receive a bolus dose of 1µg/kg dexmedetomidine 15 minute after endotracheal intubation over 10 minutes followed by continuous infusion of 0.3 mic/kg/hour for one hour.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Control group</arm_group_label>
      <arm_group_type>Placebo Comparator</arm_group_type>
      <description>Patients will receive comparable volume of normal saline (0.9%) 15 minute after endotracheal intubation.</description>
    </arm_group>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Dexmedetomidine 0.6</intervention_name>
      <description>Patients received a bolus dose of 1μg/kg Dexmedetomidine, 15 minutes after endotracheal intubation over 10 minutes followed by infusion of 0.6 μg/kg/hr for one hour.</description>
      <arm_group_label>Dexmedetomidine 0.6 group</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Dexmedetomidine 0.3</intervention_name>
      <description>Patients received a bolus dose of 1μg/kg Dexmedetomidine, 15 minutes after endotracheal intubation over 10 minutes followed by infusion of 0.3 μg/kg/hr for one hour.</description>
      <arm_group_label>Dexmedetomidine 0.3group</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Saline</intervention_name>
      <description>Patients received over 10 minutes comparable volume of normal saline (0.9%) 15 min after endotracheal intubation followed by infusion.</description>
      <arm_group_label>Control group</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Body Mass Index above 40 kg/m2 with restrictive lung disease((forced vital capacity)&#xD;
               &lt;70% in pre-operative pulmonary function tests), of American Society of&#xD;
               anesthesiologists (ASA) physical status II and III.&#xD;
  &#xD;
            -  Aged 18-50 years.&#xD;
  &#xD;
            -  Scheduled for abdominal surgery.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Patients with Forced expiratory volume1/forced vital capacity&lt;7.&#xD;
  &#xD;
            -  Uncontrolled cardiac, respiratory, hepatic or renal diseases.&#xD;
  &#xD;
            -  Allergy to the study drug&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>50 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <location>
      <facility>
        <name>Tanta University</name>
        <address>
          <city>Tanta</city>
          <state>El-Gharbia</state>
          <zip>31527</zip>
          <country>Egypt</country>
        </address>
      </facility>
    </location>
    <location_countries>
      <country>Egypt</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>July 2, 2023</study_first_submitted>
    <study_first_submitted_qc>August 30, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 31, 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>Zeinab Tawfik</investigator_full_name>
      <investigator_title>Assistant lecturer in Anesthesiology, Surgical ICU and Pain Medicine</investigator_title>
    </responsible_party>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Obesity, Morbid</mesh_term>
    </condition_browse>
    <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/NCT06018948
  org study id: 33360/09/19
  nct id: NCT06018948
  lead sponsor: 
  has dmc: Yes
  is fda regulated drug: No
  is fda regulated device: No
  Compare the effects of two different doses of dexmedetomidine infusion on oxygenation as a
        primary outcome and on lung mechanics, quality of recovery and perioperative analgesia as
        secondary outcomes in morbidly obese patients with restrictive lung disease undergoing
        abdominal surgery.
  Dexmedetomidine is a selective α2 receptor agonist and has sympatholytic, analgesic,
        anti-inflammatory and sedative properties. Dexmedetomidine decreased dead space and improved
        both lung compliance and oxygenation in chronic obstructive pulmonary disease (COPD) patients
        undergoing lung cancer surgery.
  
        The effects of dexmedetomidine on oxygenation and lung mechanics had been investigated in
        obstructive lung disease, but there are little information about its effect in morbidly obese
        patients with restrictive lung disease .
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Treatment
  masking: Double (Participant, Outcomes Assessor)
  measure: Intraoperative oxygenation
  time frame: Intraoperative
  description: Intraoperative oxygenation was assessed by P/F ratio (Arterial oxygen tension/fraction of inspired oxygen) at baseline and the end of drug infusion.
  measure: Dynamic Lung compliance
  time frame: Intraoperative
  description: Dynamic lung compliance=tidal volume/ (peak airway pressure- Positive end-expiratory pressure).
  measure: Post-operative pain
  time frame: 24 hour postoperatively
  description: Assessment of post-operative pain by The 11-point numeric scale ranges from '0' representing one pain extreme (e.g. "no pain") to '10' representing the other pain extreme
  measure: Dead space (dead space to tidal volume)
  time frame: Intraoperative
  description: Physiological dead space was calculated by Hardman and Aitkenhead equation: (dead space to tidal volume) = 1.14(PaCO2 -EtCO2)/PaCO2- 0.005 dead space (%) = dead space by end of infusion - dead space at the base line / dead space by the end of drug infusion %
  measure: Quality of recovery score
  time frame: 24 hours Postoperatively
  description: The Quality of recovery score scale provides a score ranging from 0 to 150, with a high score indicating a good quality of recovery
  measure: Time to first rescue analgesia
  time frame: 24 hours Postoperatively
  description: Time to first rescue analgesia as morphine consumption was recorded
  measure: Static lung compliance
  time frame: Intraoperative
  description: Static lung compliance =tidal volume /(plateau pressure - Positive end-expiratory pressure).
  measure: Lung compliance
  time frame: 24 hours
  description: compliance = dynamic compliance at the end of the drug infusion - baseline dynamic compliance.
  measure: Plateau pressure
  time frame: Intraoperative
  description: Plateau pressure was calculated by increasing end inspiratory pause to 30-40%.
  arm group label: Dexmedetomidine 0.6 group
  arm group type: Active Comparator
  description: patients will receive a bolus dose of 1µg/kg dexmedetomidine15 minute after endotracheal intubation over 10 minutes followed by continuous infusion of 0.6 mic/kg/hour for one hour.
  arm group label: Dexmedetomidine 0.3group
  arm group type: Active Comparator
  description: patients will receive a bolus dose of 1µg/kg dexmedetomidine 15 minute after endotracheal intubation over 10 minutes followed by continuous infusion of 0.3 mic/kg/hour for one hour.
  arm group label: Control group
  arm group type: Placebo Comparator
  description: Patients will receive comparable volume of normal saline (0.9%) 15 minute after endotracheal intubation.
  intervention type: Drug
  intervention name: Dexmedetomidine 0.6
  description: Patients received a bolus dose of 1μg/kg Dexmedetomidine, 15 minutes after endotracheal intubation over 10 minutes followed by infusion of 0.6 μg/kg/hr for one hour.
  arm group label: Dexmedetomidine 0.6 group
  intervention type: Drug
  intervention name: Dexmedetomidine 0.3
  description: Patients received a bolus dose of 1μg/kg Dexmedetomidine, 15 minutes after endotracheal intubation over 10 minutes followed by infusion of 0.3 μg/kg/hr for one hour.
  arm group label: Dexmedetomidine 0.3group
  intervention type: Drug
  intervention name: Saline
  description: Patients received over 10 minutes comparable volume of normal saline (0.9%) 15 min after endotracheal intubation followed by infusion.
  arm group label: Control group
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 50 Years
  healthy volunteers: No
  facility: 
  country: Egypt
  responsible party type: Principal Investigator
  investigator affiliation: Tanta University
  investigator full name: Zeinab Tawfik
  investigator title: Assistant lecturer in Anesthesiology, Surgical ICU and Pain Medicine
  mesh term: Obesity, Morbid
  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