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/NCT05996588</url>
    </required_header>
    <id_info>
      <org_study_id>SIUT-ERC-2021/A-325</org_study_id>
      <nct_id>NCT05996588</nct_id>
    </id_info>
    <brief_title>Comparison Between Sevoflurane and Propofol for Maintenance of Sedation During ERCP</brief_title>
    <official_title>Comparison Between Inhalational Anesthetic (Sevoflurane) and Intravenous Anesthetic (Propofol Infusion) for Maintenance of Sedation During Endoscopic Retrograde Cholangiopancreatography</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Sindh Institute of Urology and Transplantation</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Sindh Institute of Urology and Transplantation</source>
    <oversight_info>
      <has_dmc>Yes</has_dmc>
      <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
      <is_us_export>Yes</is_us_export>
    </oversight_info>
    <brief_summary>
      <textblock>
        After approval of ethical committee of Sindh Institute of Urology &amp; Transplantation (SIUT),&#xD;
        86 patients were enrolled for the elective endoscopic retrograde cholangiopancreatography&#xD;
        (ERCP). Randomization was done by a computer-generated randomization table. Patients were&#xD;
        divided in two groups based on agents used for the research study. Both the groups were&#xD;
        induced by injection midazolam 0.06 mg/kg body weight and injection nalbuphine 0.1 mg/kg body&#xD;
        weight. In group A, anesthesia was maintained by Sevoflurane inhalation via nasal prongs with&#xD;
        oxygen to achieve minimum alveolar concentration (MAC) approximately 0.25%. Whereas, in Group&#xD;
        B propofol infusion at 50 ug/Kg/min started for maintenance of anaesthesia. Ketamine 0.5mg/kg&#xD;
        intravenously was used to rescue the sedation level in both groups&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        After approval of ethical committee of SIUT, 86 patients were enrolled for the elective&#xD;
        endoscopic retrograde cholangiopancreatography (ERCP). Pre-operative assessment was done by&#xD;
        history of patients, general physical examination, systematic examination, and laboratory&#xD;
        investigations. Randomization was done by a computer-generated randomization table. Patients&#xD;
        were divided in two groups based on agents used for the research study. Both the groups were&#xD;
        induced by injection midazolam 0.06 mg/kg body weight and injection nalbuphine 0.1 mg/kg body&#xD;
        weight. In group A, anesthesia was maintained by Sevoflurane inhalation via nasal prongs with&#xD;
        oxygen to achieve minimum alveolar concentration (MAC) approximately 0.25%. Whereas, in Group&#xD;
        B propofol infusion at 50 ug/Kilogram/min started for maintenance of anaesthesia.&#xD;
  &#xD;
        When Ramsay Sedation Scale 5 is achieved then the endoscopist was allowed to insert&#xD;
        endoscope. Injection Ketamine 0.5 mg/kg body weight was used for rescue sedation level. Upon&#xD;
        arrival in operation theatre standard monitoring which includes pulse oximeter (SPO2),&#xD;
        noninvasive blood pressure (NIBP), electrocardiogram (ECG) electrodes were applied, and&#xD;
        baseline readings will be recorded. After that venous access was secured on a non-dominant&#xD;
        hand by 20 Gauge IV cannula. Ringer's lactate or normal saline was then started at 8&#xD;
        ml/kg/hour and O2 was given by nasal prongs at 4 L/min. All baseline parameters were taken,&#xD;
        after that readings were taken at 5 min, 10 min, 15 min, 20 min and so on till procedure&#xD;
        ends.&#xD;
  &#xD;
        Complications such as respiratory depression, coughing, gagging, nausea and vomiting were&#xD;
        recorded during the procedure and treated accordingly. If SpO2 went down below 92% for more&#xD;
        than 10 seconds or patient developed apnea, it was considered oxygen desaturation.&#xD;
  &#xD;
        Oxygen desaturation was managed by O2 inhalation and supporting airway. A heart rate under 40&#xD;
        beats per minute was considered bradycardia and it will be managed by inj Atropine 10&#xD;
        ug/Kilogram intravenously (I/V). Mean arterial pressures level that is lower than 60 mmHg or&#xD;
        20% less than the baseline was regarded as hypotension and it was managed by fluid bolus or&#xD;
        vasopressors.&#xD;
  &#xD;
        After the procedure, patients were awakened and shifted to recovery room. Complications such&#xD;
        as respiratory depression, coughing, gagging, nausea and vomiting were recorded and treated&#xD;
        accordingly.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Completed</overall_status>
    <start_date type="Actual">January 5, 2022</start_date>
    <completion_date type="Actual">November 25, 2022</completion_date>
    <primary_completion_date type="Actual">November 25, 2022</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>Ramsay sedation score</measure>
      <time_frame>0-2 hours</time_frame>
      <description>Clinical Score Patient's Characteristics&#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 stimulus&#xD;
  Asleep; sluggish response to light glabellar tap or loud auditory stimulus&#xD;
  Asleep; no response to glabellar tap or loud auditory stimulus</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Heart rate</measure>
      <time_frame>0-2 hours</time_frame>
      <description>Heart rate via vitals monitoring device</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Mean arterial blood pressure</measure>
      <time_frame>0-2 hours</time_frame>
      <description>Mean arterial blood pressure via a non-invasive blood pressure monitor</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Oxygen saturation</measure>
      <time_frame>0-2 hours</time_frame>
      <description>Oxygen saturation via a pulse oximeter</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Respiratory rate</measure>
      <time_frame>0-2 hours</time_frame>
      <description>Respiratory rate via a vitals monitoring device</description>
    </primary_outcome>
    <other_outcome>
      <measure>Number of patients with post operative nausea</measure>
      <time_frame>0-2 hours</time_frame>
      <description>Feeling of patient to vomit out</description>
    </other_outcome>
    <other_outcome>
      <measure>Number of patients with post operative vomiting</measure>
      <time_frame>0-2 hours</time_frame>
      <description>Expulsion of stomach contents</description>
    </other_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Actual">86</enrollment>
    <condition>Sedation Complication</condition>
    <arm_group>
      <arm_group_label>Propofol</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>Propofol at a rate of 50 microgram/kg/min</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Sevoflurane</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Sevoflurane inhalation with oxygen via nasal prongs at a concentration 4-5% to achieve a MAC of 0.25</description>
    </arm_group>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Propofol 1 % Injectable Suspension</intervention_name>
      <description>Propofol 1 % Injectable Suspension at a rate of 50 microgram/kg/min intravenously</description>
      <arm_group_label>Propofol</arm_group_label>
      <other_name>Propofol</other_name>
    </intervention>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Sevoflurane</intervention_name>
      <description>Sevoflurane inhalation anaesthetic at a concentration of 4-5% to achieve a MAC of 0.25</description>
      <arm_group_label>Sevoflurane</arm_group_label>
      <other_name>Sevoflurane inhalation anaesthetic</other_name>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Patients between age group of 20-60 years&#xD;
  &#xD;
            -  Both male and female patients.&#xD;
  &#xD;
            -  American Society of Anesthesiologist (ASA) physical status I-II&#xD;
  &#xD;
            -  Elective ERCP procedure.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Patients allergic to any study drug.&#xD;
  &#xD;
            -  American Society of Anesthesiology (ASA) Physical status III-IV&#xD;
  &#xD;
            -  Patients with uncontrolled Diabetes Mellitus,&#xD;
  &#xD;
            -  Hypertension and renal insufficiency.&#xD;
  &#xD;
            -  Body mass index (BMI) over 36 Kilogram/m2 (Morbid obesity)&#xD;
  &#xD;
            -  Obstructive Sleep Apnea&#xD;
  &#xD;
            -  Gastroesophageal reflux disease (GERD)&#xD;
  &#xD;
            -  Pregnancy&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>20 Years</minimum_age>
      <maximum_age>60 Years</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Muhammad Q Abbas, FCPS</last_name>
      <role>Study Chair</role>
      <affiliation>Professor Dept of Anaesthesiology</affiliation>
    </overall_official>
    <location>
      <facility>
        <name>Syed Muhammad Abbas</name>
        <address>
          <city>Karachi</city>
          <state>Sindh</state>
          <zip>74200</zip>
          <country>Pakistan</country>
        </address>
      </facility>
    </location>
    <location_countries>
      <country>Pakistan</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>July 30, 2023</study_first_submitted>
    <study_first_submitted_qc>August 13, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 18, 2023</study_first_posted>
    <last_update_submitted>August 13, 2023</last_update_submitted>
    <last_update_submitted_qc>August 13, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 18, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Sindh Institute of Urology and Transplantation</investigator_affiliation>
      <investigator_full_name>Syed Muhammad Abbas</investigator_full_name>
      <investigator_title>Associate Professor, Department of Anaesthesia</investigator_title>
    </responsible_party>
    <intervention_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Propofol</mesh_term>
      <mesh_term>Anesthetics</mesh_term>
      <mesh_term>Sevoflurane</mesh_term>
      <mesh_term>Anesthetics, Inhalation</mesh_term>
    </intervention_browse>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
    </patient_data>
    <provided_document_section>
      <provided_document>
        <document_type>Study Protocol</document_type>
        <document_has_protocol>Yes</document_has_protocol>
        <document_has_icf>No</document_has_icf>
        <document_has_sap>No</document_has_sap>
        <document_date>July 1, 2021</document_date>
        <document_url>https://ClinicalTrials.gov/ProvidedDocs/88/NCT05996588/Prot_000.pdf</document_url>
      </provided_document>
      <provided_document>
        <document_type>Statistical Analysis Plan</document_type>
        <document_has_protocol>No</document_has_protocol>
        <document_has_icf>No</document_has_icf>
        <document_has_sap>Yes</document_has_sap>
        <document_date>July 1, 2021</document_date>
        <document_url>https://ClinicalTrials.gov/ProvidedDocs/88/NCT05996588/SAP_001.pdf</document_url>
      </provided_document>
      <provided_document>
        <document_type>Informed Consent Form</document_type>
        <document_has_protocol>No</document_has_protocol>
        <document_has_icf>Yes</document_has_icf>
        <document_has_sap>No</document_has_sap>
        <document_date>July 1, 2021</document_date>
        <document_url>https://ClinicalTrials.gov/ProvidedDocs/88/NCT05996588/ICF_002.pdf</document_url>
      </provided_document>
    </provided_document_section>
    <!-- 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/NCT05996588
  org study id: SIUT-ERC-2021/A-325
  nct id: NCT05996588
  lead sponsor: 
  has dmc: Yes
  is fda regulated drug: Yes
  is fda regulated device: No
  is us export: Yes
  After approval of ethical committee of Sindh Institute of Urology & Transplantation (SIUT),
        86 patients were enrolled for the elective endoscopic retrograde cholangiopancreatography
        (ERCP). Randomization was done by a computer-generated randomization table. Patients were
        divided in two groups based on agents used for the research study. Both the groups were
        induced by injection midazolam 0.06 mg/kg body weight and injection nalbuphine 0.1 mg/kg body
        weight. In group A, anesthesia was maintained by Sevoflurane inhalation via nasal prongs with
        oxygen to achieve minimum alveolar concentration (MAC) approximately 0.25%. Whereas, in Group
        B propofol infusion at 50 ug/Kg/min started for maintenance of anaesthesia. Ketamine 0.5mg/kg
        intravenously was used to rescue the sedation level in both groups
  After approval of ethical committee of SIUT, 86 patients were enrolled for the elective
        endoscopic retrograde cholangiopancreatography (ERCP). Pre-operative assessment was done by
        history of patients, general physical examination, systematic examination, and laboratory
        investigations. Randomization was done by a computer-generated randomization table. Patients
        were divided in two groups based on agents used for the research study. Both the groups were
        induced by injection midazolam 0.06 mg/kg body weight and injection nalbuphine 0.1 mg/kg body
        weight. In group A, anesthesia was maintained by Sevoflurane inhalation via nasal prongs with
        oxygen to achieve minimum alveolar concentration (MAC) approximately 0.25%. Whereas, in Group
        B propofol infusion at 50 ug/Kilogram/min started for maintenance of anaesthesia.
  
        When Ramsay Sedation Scale 5 is achieved then the endoscopist was allowed to insert
        endoscope. Injection Ketamine 0.5 mg/kg body weight was used for rescue sedation level. Upon
        arrival in operation theatre standard monitoring which includes pulse oximeter (SPO2),
        noninvasive blood pressure (NIBP), electrocardiogram (ECG) electrodes were applied, and
        baseline readings will be recorded. After that venous access was secured on a non-dominant
        hand by 20 Gauge IV cannula. Ringer's lactate or normal saline was then started at 8
        ml/kg/hour and O2 was given by nasal prongs at 4 L/min. All baseline parameters were taken,
        after that readings were taken at 5 min, 10 min, 15 min, 20 min and so on till procedure
        ends.
  
        Complications such as respiratory depression, coughing, gagging, nausea and vomiting were
        recorded during the procedure and treated accordingly. If SpO2 went down below 92% for more
        than 10 seconds or patient developed apnea, it was considered oxygen desaturation.
  
        Oxygen desaturation was managed by O2 inhalation and supporting airway. A heart rate under 40
        beats per minute was considered bradycardia and it will be managed by inj Atropine 10
        ug/Kilogram intravenously (I/V). Mean arterial pressures level that is lower than 60 mmHg or
        20% less than the baseline was regarded as hypotension and it was managed by fluid bolus or
        vasopressors.
  
        After the procedure, patients were awakened and shifted to recovery room. Complications such
        as respiratory depression, coughing, gagging, nausea and vomiting were recorded and treated
        accordingly.
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Treatment
  masking: None (Open Label)
  measure: Ramsay sedation score
  time frame: 0-2 hours
  description: Clinical Score Patient's Characteristics
  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 stimulus
  Asleep; sluggish response to light glabellar tap or loud auditory stimulus
  Asleep; no response to glabellar tap or loud auditory stimulus
  measure: Heart rate
  time frame: 0-2 hours
  description: Heart rate via vitals monitoring device
  measure: Mean arterial blood pressure
  time frame: 0-2 hours
  description: Mean arterial blood pressure via a non-invasive blood pressure monitor
  measure: Oxygen saturation
  time frame: 0-2 hours
  description: Oxygen saturation via a pulse oximeter
  measure: Respiratory rate
  time frame: 0-2 hours
  description: Respiratory rate via a vitals monitoring device
  measure: Number of patients with post operative nausea
  time frame: 0-2 hours
  description: Feeling of patient to vomit out
  measure: Number of patients with post operative vomiting
  time frame: 0-2 hours
  description: Expulsion of stomach contents
  arm group label: Propofol
  arm group type: Active Comparator
  description: Propofol at a rate of 50 microgram/kg/min
  arm group label: Sevoflurane
  arm group type: Experimental
  description: Sevoflurane inhalation with oxygen via nasal prongs at a concentration 4-5% to achieve a MAC of 0.25
  intervention type: Drug
  intervention name: Propofol 1 % Injectable Suspension
  description: Propofol 1 % Injectable Suspension at a rate of 50 microgram/kg/min intravenously
  arm group label: Propofol
  other name: Propofol
  intervention type: Drug
  intervention name: Sevoflurane
  description: Sevoflurane inhalation anaesthetic at a concentration of 4-5% to achieve a MAC of 0.25
  arm group label: Sevoflurane
  other name: Sevoflurane inhalation anaesthetic
  criteria: 
  gender: All
  minimum age: 20 Years
  maximum age: 60 Years
  healthy volunteers: Accepts Healthy Volunteers
  last name: Muhammad Q Abbas, FCPS
  role: Study Chair
  affiliation: Professor Dept of Anaesthesiology
  facility: 
  country: Pakistan
  responsible party type: Principal Investigator
  investigator affiliation: Sindh Institute of Urology and Transplantation
  investigator full name: Syed Muhammad Abbas
  investigator title: Associate Professor, Department of Anaesthesia
  mesh term: Propofol
  mesh term: Anesthetics
  mesh term: Sevoflurane
  mesh term: Anesthetics, Inhalation
  sharing ipd: No
  provided document: 
  provided document: 
  provided document: 