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/NCT05962671</url>
    </required_header>
    <id_info>
      <org_study_id>36264MS154/4/23</org_study_id>
      <nct_id>NCT05962671</nct_id>
    </id_info>
    <brief_title>Opioid-sparing Versus Sevoflurane Anesthesia on Early Postoperative Hypoventilation in Laparoscopic Bariatric Surgery</brief_title>
    <official_title>Opioid-sparing Versus Sevoflurane-based Anesthesia on Early Postoperative Hypoventilation in Patients Undergoing Laparoscopic Bariatric Surgery: Prospective Randomized 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>
        Determine the incidence of early post-operative hypoventilation in post-anesthesia care unit&#xD;
        (PACU) in patients undergoing laparoscopic bariatric surgery under opioid-sparing compared&#xD;
        with sevoflurane-based anesthesia.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        The incidence of early postoperative hypoxemia in the literature is diverse, this may be due&#xD;
        to multivariable, including patient-related factors, anesthesia-related factors, and&#xD;
        surgery-related factors. Because of the controverse regarding the incidence of postoperative&#xD;
        hypoxemia and the evidence of anesthetic technique of choice, interest in prevention and&#xD;
        early management of early postoperative hypoxemia after laparoscopic bariatric surgery is&#xD;
        continued.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">August 10, 2023</start_date>
    <completion_date type="Anticipated">March 30, 2024</completion_date>
    <primary_completion_date type="Anticipated">March 30, 2024</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>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Incidence of Early postoperative hypoventilation</measure>
      <time_frame>UP to 24 hours Postoperatively</time_frame>
      <description>Early postoperative respiratory hypoventilation will be defined by any of the following parameters:&#xD;
  Oxygen saturation &lt; 95% for 10 seconds. Respiratory rate &lt; 8 breath/min. Apnea spill &gt; 10 seconds. pain/sedation-mismatch.</description>
    </primary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">72</enrollment>
    <condition>Anesthesia</condition>
    <condition>Hypoventilation</condition>
    <condition>Opioid Use</condition>
    <condition>Bariatric Surgery</condition>
    <arm_group>
      <arm_group_label>Opioid-sparing based anesthesia</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>Intraoperative opioid-sparing maintenance comprised dexmedetomidine bolus dose of 1 mcg/kg followed by 0.3 mcg/kg/h, propofol 4-8 mg/kg/h and ketamine 25 mg/h for a max of 50 mg during the procedure, targeting bispectral index (BIS) between 45%-60%. The lean body weight will be used for calculation of the drugs.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Sevoflurane-based anesthesia</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>Intraoperative sevoflurane-based anesthesia, 0.8 to 1.0 Minimum alveolar concentration will be used combined with fentanyl 1 mcg/kg followed by 1 -2 mcg/kg/h and cis-atracurium, to keep bispectral index between 45% to 60%.</description>
    </arm_group>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Opioid-sparing based anesthesia</intervention_name>
      <description>Intraoperative opioid-sparing maintenance comprised dexmedetomidine bolus dose of 1 mcg/kg followed by 0.3 mcg/kg/h, propofol 4-8 mg/kg/h and ketamine 25 mg/h for a max of 50 mg during the procedure, targeting bispectral index (BIS) between 45%-60%. The lean body weight will be used for calculation of the drugs.</description>
      <arm_group_label>Opioid-sparing based anesthesia</arm_group_label>
      <other_name>Opioid</other_name>
    </intervention>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Sevoflurane-based anesthesia</intervention_name>
      <description>Intraoperative sevoflurane-based anesthesia, 0.8 to 1.0 Minimum alveolar concentration will be used combined with fentanyl 1 mcg/kg followed by 1 -2 mcg/kg/h and cis-atracurium, to keep bispectral index between 45% to 60%.</description>
      <arm_group_label>Sevoflurane-based anesthesia</arm_group_label>
      <other_name>Sevoflurane</other_name>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  All adult patients ≥ 18 years&#xD;
  &#xD;
            -  Admitted to the post anesthesia care unit after bariatric surgery&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
          • Preoperative hypoxemia which is determined by a peripheral capillary oxygen saturation&#xD;
          (SPO2) reading of &lt; 90% on room air&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_contact>
      <last_name>Samah M Marie, MBBCh</last_name>
      <phone>+20 120 745 203</phone>
      <email>mohamedsamah084@gmail.com</email>
    </overall_contact>
    <location>
      <facility>
        <name>Tanta University</name>
        <address>
          <city>Tanta</city>
          <state>El-Gharbia</state>
          <zip>31527</zip>
          <country>Egypt</country>
        </address>
      </facility>
      <contact>
        <last_name>Samah M Marie, MBBCH</last_name>
        <phone>+20 120 745 203</phone>
        <email>mohamedsamah084@gmail.com</email>
      </contact>
    </location>
    <location_countries>
      <country>Egypt</country>
    </location_countries>
    <verification_date>July 2023</verification_date>
    <study_first_submitted>June 24, 2023</study_first_submitted>
    <study_first_submitted_qc>July 26, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">July 27, 2023</study_first_posted>
    <last_update_submitted>July 26, 2023</last_update_submitted>
    <last_update_submitted_qc>July 26, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">July 27, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Tanta University</investigator_affiliation>
      <investigator_full_name>Samah Mohamed Marie</investigator_full_name>
      <investigator_title>Doctor resident of Anesthesiology, Surgical Intensive Care and Pain Medicine</investigator_title>
    </responsible_party>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Hypoventilation</mesh_term>
    </condition_browse>
    <intervention_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Analgesics, Opioid</mesh_term>
      <mesh_term>Anesthetics</mesh_term>
      <mesh_term>Sevoflurane</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/NCT05962671
  org study id: 36264MS154/4/23
  nct id: NCT05962671
  lead sponsor: 
  has dmc: Yes
  is fda regulated drug: No
  is fda regulated device: No
  Determine the incidence of early post-operative hypoventilation in post-anesthesia care unit
        (PACU) in patients undergoing laparoscopic bariatric surgery under opioid-sparing compared
        with sevoflurane-based anesthesia.
  The incidence of early postoperative hypoxemia in the literature is diverse, this may be due
        to multivariable, including patient-related factors, anesthesia-related factors, and
        surgery-related factors. Because of the controverse regarding the incidence of postoperative
        hypoxemia and the evidence of anesthetic technique of choice, interest in prevention and
        early management of early postoperative hypoxemia after laparoscopic bariatric surgery is
        continued.
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Treatment
  masking: None (Open Label)
  measure: Incidence of Early postoperative hypoventilation
  time frame: UP to 24 hours Postoperatively
  description: Early postoperative respiratory hypoventilation will be defined by any of the following parameters:
  Oxygen saturation < 95% for 10 seconds. Respiratory rate < 8 breath/min. Apnea spill > 10 seconds. pain/sedation-mismatch.
  arm group label: Opioid-sparing based anesthesia
  arm group type: Active Comparator
  description: Intraoperative opioid-sparing maintenance comprised dexmedetomidine bolus dose of 1 mcg/kg followed by 0.3 mcg/kg/h, propofol 4-8 mg/kg/h and ketamine 25 mg/h for a max of 50 mg during the procedure, targeting bispectral index (BIS) between 45%-60%. The lean body weight will be used for calculation of the drugs.
  arm group label: Sevoflurane-based anesthesia
  arm group type: Active Comparator
  description: Intraoperative sevoflurane-based anesthesia, 0.8 to 1.0 Minimum alveolar concentration will be used combined with fentanyl 1 mcg/kg followed by 1 -2 mcg/kg/h and cis-atracurium, to keep bispectral index between 45% to 60%.
  intervention type: Drug
  intervention name: Opioid-sparing based anesthesia
  description: Intraoperative opioid-sparing maintenance comprised dexmedetomidine bolus dose of 1 mcg/kg followed by 0.3 mcg/kg/h, propofol 4-8 mg/kg/h and ketamine 25 mg/h for a max of 50 mg during the procedure, targeting bispectral index (BIS) between 45%-60%. The lean body weight will be used for calculation of the drugs.
  arm group label: Opioid-sparing based anesthesia
  other name: Opioid
  intervention type: Drug
  intervention name: Sevoflurane-based anesthesia
  description: Intraoperative sevoflurane-based anesthesia, 0.8 to 1.0 Minimum alveolar concentration will be used combined with fentanyl 1 mcg/kg followed by 1 -2 mcg/kg/h and cis-atracurium, to keep bispectral index between 45% to 60%.
  arm group label: Sevoflurane-based anesthesia
  other name: Sevoflurane
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: No
  last name: Samah M Marie, MBBCh
  phone: +20 120 745 203
  email: mohamedsamah084@gmail.com
  facility: 
  contact: 
  country: Egypt
  responsible party type: Principal Investigator
  investigator affiliation: Tanta University
  investigator full name: Samah Mohamed Marie
  investigator title: Doctor resident of Anesthesiology, Surgical Intensive Care and Pain Medicine
  mesh term: Hypoventilation
  mesh term: Analgesics, Opioid
  mesh term: Anesthetics
  mesh term: Sevoflurane
  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