<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/NCT03803449</url>
  </required_header>
  <id_info>
    <org_study_id>2018SDU-QILU-069</org_study_id>
    <nct_id>NCT03803449</nct_id>
  </id_info>
  <brief_title>Patient Satisfaction and Safety With Propofol Based Sedation With or Without Fentanyl for Gastrointestinal Endoscopy</brief_title>
  <official_title>Patient Satisfaction and Safety With Propofol Based Sedation With or Without Fentanyl for Gastrointestinal Endoscopy :a Prospective ,Randomized ,and Cohort Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Shandong University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Shandong 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>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      Patient satisfaction and safety with propofol based sedation with or without fentanyl for&#xD;
      gastrointestinal endoscopy&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This study divide patients into two groups, one will be given propofol midazolam and&#xD;
      fentanyl; another group was given propofol with midazolam without fentanyl; to observe two&#xD;
      groups of patients blood pressure, body movement, and propofol dosage , and the difference in&#xD;
      operator satisfaction, and how many people need to give fentanyl again; and two groups of&#xD;
      patients after the operation of the reaction, if there are dizziness, nausea, and other&#xD;
      adverse reactions; finally, the differences of these two schemes in different populations&#xD;
      were analyzed, and the rationalization and individualized medication will be put forward.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date type="Anticipated">January 1, 2019</start_date>
  <completion_date type="Anticipated">October 30, 2019</completion_date>
  <primary_completion_date type="Anticipated">July 30, 2019</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>
    <intervention_model_description>Participants are randomly assigned to group A or B. Participants of group A are given propofol midazolam and fentanyl; while participants of group B are given propofol with midazolam without fentany</intervention_model_description>
    <primary_purpose>Health Services Research</primary_purpose>
    <masking>Double (Care Provider, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Satisfaction assessed by the rate of vomit and diazzy after the procedure</measure>
    <time_frame>half a year</time_frame>
    <description>Rates of vomit and diazzy of patients after the procedure between the two groups</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Safety assessed by the rate of hypoxia during the procedure</measure>
    <time_frame>half a year</time_frame>
    <description>Hypoxia, defined as peripheral oxygen saturation &lt;90% for &gt;30 seconds</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Safety assessed by the rate of hypotention during the procedure</measure>
    <time_frame>half a year</time_frame>
    <description>Hypotension, defined as systolic blood pressure &lt;90 mmHg</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Safety assessed by the rate of hyoxemia during the procedure</measure>
    <time_frame>half a year</time_frame>
    <description>Hypoxia, defined as peripheral oxygen saturation &lt;90% for &gt;30 seconds</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Safety assessed by the rate of breadycardia during the procedure</measure>
    <time_frame>half a year</time_frame>
    <description>Bradycardia, defined as heart rate &lt;50 beats/min</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Safety assessed by the rate of required airway management during the procedure</measure>
    <time_frame>half a year</time_frame>
    <description>Required airway management such as jaw lifting, mask ventilation, or tracheal intubation in severe hypoxia</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Safety assessed by the rate of involuntary movement during the procedure</measure>
    <time_frame>half a year</time_frame>
    <description>Involuntary movements, defined as unconscious movements requiring restraint or severe limb movement interrupting the endoscopy procedure</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">500</enrollment>
  <condition>Patient Satisfaction</condition>
  <arm_group>
    <arm_group_label>Control group</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Participants are given standard regimen: 50-200mg propofol and 1 mg midazolam</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Fentanyl group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants are given intervention regimen: 50ug fentanyl, plus 50-200mg propofol and 1 mg midazolam.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>50-200mg propofol</intervention_name>
    <description>participants in both groups are given standard regimen including 50-200mg propofol.</description>
    <arm_group_label>Control group</arm_group_label>
    <arm_group_label>Fentanyl group</arm_group_label>
    <other_name>Jingan, J20110055</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>50ug fentanyl</intervention_name>
    <description>participants in fentanyl group are given intervention regimen: 50ug fentanyl.</description>
    <arm_group_label>Fentanyl group</arm_group_label>
    <other_name>Yichang, H42022076</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>1 mg midazolam</intervention_name>
    <description>participants in both groups are given standard regimen including 1 mg midazolam.</description>
    <arm_group_label>Control group</arm_group_label>
    <arm_group_label>Fentanyl group</arm_group_label>
    <other_name>Liyuexi, H10980025</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients aged 18 or older&#xD;
&#xD;
          -  Patients scheduled for an outpatient gastrointestinal endoscopy by the principal&#xD;
             investigator.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients with a history of colorectal surgery&#xD;
&#xD;
          -  Patients with ASA class 4 or 5,&#xD;
&#xD;
          -  Patients with pre-existing hypoxaemia (SpO2&lt;90%),&#xD;
&#xD;
          -  Patients with hypotension (SBP&lt;90mmHg)&#xD;
&#xD;
          -  Patients with bradycardia (HR&lt;50 bpm)&#xD;
&#xD;
          -  patients with severe chronic renal failure (creatinine clearance&lt;30 ml/min)&#xD;
&#xD;
          -  patients with uncontrolled hypertension (systolic blood pressure&gt;170 mm Hg, diastolic&#xD;
             blood pressure&gt;100 mm Hg)&#xD;
&#xD;
          -  patients with pregnancy or lactation&#xD;
&#xD;
          -  Patients hemodynamically unstable&#xD;
&#xD;
          -  Patients unable to give informed consent&#xD;
&#xD;
          -  Patients with a history of drug allergies;&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>75 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>yanqing li, Dr.</last_name>
    <role>Study Chair</role>
    <affiliation>Qilu Hospital of Shandong University</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>jing liu</last_name>
    <phone>+86-18560083755</phone>
    <email>1057986797@qq.com</email>
  </overall_contact>
  <verification_date>January 2019</verification_date>
  <study_first_submitted>April 22, 2018</study_first_submitted>
  <study_first_submitted_qc>January 10, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 14, 2019</study_first_posted>
  <last_update_submitted>January 10, 2019</last_update_submitted>
  <last_update_submitted_qc>January 10, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">January 14, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Shandong University</investigator_affiliation>
    <investigator_full_name>Yanqing Li</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <keyword>propofol</keyword>
  <keyword>fentanyl</keyword>
  <keyword>gastrointestinal endoscopy</keyword>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Fentanyl</mesh_term>
    <mesh_term>Midazolam</mesh_term>
    <mesh_term>Propofol</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


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/NCT03803449
org study id: 2018SDU-QILU-069
nct id: NCT03803449
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
is us export: No
Patient satisfaction and safety with propofol based sedation with or without fentanyl for
      gastrointestinal endoscopy
This study divide patients into two groups, one will be given propofol midazolam and
      fentanyl; another group was given propofol with midazolam without fentanyl; to observe two
      groups of patients blood pressure, body movement, and propofol dosage , and the difference in
      operator satisfaction, and how many people need to give fentanyl again; and two groups of
      patients after the operation of the reaction, if there are dizziness, nausea, and other
      adverse reactions; finally, the differences of these two schemes in different populations
      were analyzed, and the rationalization and individualized medication will be put forward.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: Participants are randomly assigned to group A or B. Participants of group A are given propofol midazolam and fentanyl; while participants of group B are given propofol with midazolam without fentany
primary purpose: Health Services Research
masking: Double (Care Provider, Outcomes Assessor)
measure: Satisfaction assessed by the rate of vomit and diazzy after the procedure
time frame: half a year
description: Rates of vomit and diazzy of patients after the procedure between the two groups
measure: Safety assessed by the rate of hypoxia during the procedure
time frame: half a year
description: Hypoxia, defined as peripheral oxygen saturation <90% for >30 seconds
measure: Safety assessed by the rate of hypotention during the procedure
time frame: half a year
description: Hypotension, defined as systolic blood pressure <90 mmHg
measure: Safety assessed by the rate of hyoxemia during the procedure
time frame: half a year
description: Hypoxia, defined as peripheral oxygen saturation <90% for >30 seconds
measure: Safety assessed by the rate of breadycardia during the procedure
time frame: half a year
description: Bradycardia, defined as heart rate <50 beats/min
measure: Safety assessed by the rate of required airway management during the procedure
time frame: half a year
description: Required airway management such as jaw lifting, mask ventilation, or tracheal intubation in severe hypoxia
measure: Safety assessed by the rate of involuntary movement during the procedure
time frame: half a year
description: Involuntary movements, defined as unconscious movements requiring restraint or severe limb movement interrupting the endoscopy procedure
arm group label: Control group
arm group type: Active Comparator
description: Participants are given standard regimen: 50-200mg propofol and 1 mg midazolam
arm group label: Fentanyl group
arm group type: Experimental
description: Participants are given intervention regimen: 50ug fentanyl, plus 50-200mg propofol and 1 mg midazolam.
intervention type: Drug
intervention name: 50-200mg propofol
description: participants in both groups are given standard regimen including 50-200mg propofol.
arm group label: Control group
arm group label: Fentanyl group
other name: Jingan, J20110055
intervention type: Drug
intervention name: 50ug fentanyl
description: participants in fentanyl group are given intervention regimen: 50ug fentanyl.
arm group label: Fentanyl group
other name: Yichang, H42022076
intervention type: Drug
intervention name: 1 mg midazolam
description: participants in both groups are given standard regimen including 1 mg midazolam.
arm group label: Control group
arm group label: Fentanyl group
other name: Liyuexi, H10980025
criteria: 
gender: All
minimum age: 18 Years
maximum age: 75 Years
healthy volunteers: Accepts Healthy Volunteers
last name: yanqing li, Dr.
role: Study Chair
affiliation: Qilu Hospital of Shandong University
last name: jing liu
phone: +86-18560083755
email: 1057986797@qq.com
responsible party type: Principal Investigator
investigator affiliation: Shandong University
investigator full name: Yanqing Li
investigator title: Principal Investigator
mesh term: Fentanyl
mesh term: Midazolam
mesh term: Propofol
sharing ipd: Undecided