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/NCT06004843</url>
    </required_header>
    <id_info>
      <org_study_id>LY2023-115-A</org_study_id>
      <nct_id>NCT06004843</nct_id>
    </id_info>
    <brief_title>The Effects of Remimazolam on the Incidence of Hypoxia During Sedated Hysteroscopy for Assisted Reproduction in Overweight or Obese Patients</brief_title>
    <acronym>EROP</acronym>
    <official_title>The Effects of Remimazolam on the Incidence of Hypoxia During Sedated Hysteroscopy for Assisted Reproduction in Overweight or Obese Patients: a Randomized, Controlled Clinical Trial</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>RenJi Hospital</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>RenJi Hospital</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>
      <is_us_export>No</is_us_export>
    </oversight_info>
    <brief_summary>
      <textblock>
        Hypoxia is a common adverse event during sedated hysteroscopy for assisted reproduction, and&#xD;
        it is more likely to occur in overweight or obese patients. In sedated gastroscopy, the&#xD;
        incidence of hypoxia with remimazolam is lower than that with propofol. The present study is&#xD;
        a single-center, randomized, single-blind, controlled clinical trial. Overweight or obese&#xD;
        patients undergoing sedated hysteroscopy for diagnosis and treatment, with ASA grade I or II,&#xD;
        were selected as subjects and randomly divided into an experimental group and a control&#xD;
        group, with 300 subjects in each group. Sedation induction and maintenance are performed&#xD;
        using remimazolam or propofol combined with remifentanil, respectively, to compare the&#xD;
        incidence of hypoxia during surgery between the two groups of patients.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">August 2023</start_date>
    <completion_date type="Anticipated">April 2026</completion_date>
    <primary_completion_date type="Anticipated">February 2026</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>Prevention</primary_purpose>
      <masking>Single (Participant)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>The incidence of hypoxia</measure>
      <time_frame>Participants will be followed for the duration of their hospital stay, with an expected average of about 2 hours.</time_frame>
      <description>75%≤ SpO2% ≤89% for&lt;60s</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>The incidence of sub-clinical respiratory depression</measure>
      <time_frame>Participants will be followed for the duration of their hospital stay, with an expected average of about 2 hours.</time_frame>
      <description>90%≤ SpO2&lt;95%</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>The incidence of severe hypoxia</measure>
      <time_frame>Participants will be followed for the duration of their hospital stay, with an expected average of about 2 hours.</time_frame>
      <description>SpO2&lt;75% or 75%≤ SpO2≤89% for≥60s</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>The incidence of other adverse events</measure>
      <time_frame>Participants will be followed for the duration of their hospital stay, with an expected average of about 2 hours.</time_frame>
      <description>Other adverse events recorded by tools proposed by the World Society of Intravenous Anesthesia International Sedation Task Force</description>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">600</enrollment>
    <condition>Hypoxia</condition>
    <condition>Hysteroscopy</condition>
    <condition>Overweight or Obesity</condition>
    <arm_group>
      <arm_group_label>Remimazolam</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>In this group, participants are sedated with remimazolam and remifentanil.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>propofol</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>In this group, participants are sedated with propofol and remifentanil.</description>
    </arm_group>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>remimazolam</intervention_name>
      <description>in this group,patients are treated with remimazolam and remifentanil for reduced sedation.</description>
      <arm_group_label>Remimazolam</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Propofol</intervention_name>
      <description>in this group,patients are treated with propofol and remifentanil for reduced sedation.</description>
      <arm_group_label>propofol</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            1. Age between 20 and 50 years.&#xD;
  &#xD;
            2. Patients undergoing sedated hysteroscopy for assisted reproduction.&#xD;
  &#xD;
            3. ASA classification I-II.&#xD;
  &#xD;
            4. BMI ≥ 23 kg/㎡.&#xD;
  &#xD;
            5. Patients who have signed an informed consent form.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            1. SpO2 &lt; 95% in patients inhaling air upon entering the room.&#xD;
  &#xD;
            2. Diagnosed with chronic obstructive pulmonary disease (COPD) or currently suffering&#xD;
               from other acute and chronic lung diseases requiring long-term or intermittent oxygen&#xD;
               therapy.&#xD;
  &#xD;
            3. Patients with a history of mental and neurological disorders: such as depression,&#xD;
               severe central nervous system depression, Parkinson's disease, basal ganglia disease,&#xD;
               schizophrenia, epilepsy, Alzheimer's disease, myasthenia gravis, etc.&#xD;
  &#xD;
            4. Patients with severe liver dysfunction.&#xD;
  &#xD;
            5. Patients with severe renal insufficiency (requiring dialysis before surgery).&#xD;
  &#xD;
            6. Severe heart failure (METS &lt; 4).&#xD;
  &#xD;
            7. History of drug abuse and/or alcohol abuse within the 2 years preceding the screening&#xD;
               period (consuming more than three times the standard alcoholic beverages daily,&#xD;
               approximately 10g of alcohol, or equivalent to 50g of Chinese alcohol).&#xD;
  &#xD;
            8. Allergies or contraindications to benzodiazepines, flumazenil, opiates and their&#xD;
               rescue medications, propofol, eggs, or soy products.&#xD;
  &#xD;
            9. Breastfeeding women.&#xD;
  &#xD;
           10. Patients whom investigator believe are unsuitable for participating in this trial.&#xD;
        </textblock>
      </criteria>
      <gender>Female</gender>
      <gender_based>Yes</gender_based>
      <minimum_age>20 Years</minimum_age>
      <maximum_age>50 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_contact>
      <last_name>diansan su, Dr</last_name>
      <phone>+862168383702</phone>
      <email>diansansu@yahoo.com</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>yanhua he, B.S</last_name>
      <phone>+862168383702</phone>
      <email>2339570124@qq.com</email>
    </overall_contact_backup>
    <location>
      <facility>
        <name>Renji Hospital</name>
        <address>
          <city>Shanghai</city>
          <state>Pudong New Area</state>
          <country>China</country>
        </address>
      </facility>
      <contact>
        <last_name>yanhua he, B.S</last_name>
        <phone>+862168383702</phone>
        <email>2339570124@qq.com</email>
      </contact>
    </location>
    <location_countries>
      <country>China</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 16, 2023</study_first_submitted>
    <study_first_submitted_qc>August 16, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 22, 2023</study_first_posted>
    <last_update_submitted>August 24, 2023</last_update_submitted>
    <last_update_submitted_qc>August 24, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 28, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>RenJi Hospital</investigator_affiliation>
      <investigator_full_name>diansan su</investigator_full_name>
      <investigator_title>Vice chair of the department of anesthesiology</investigator_title>
    </responsible_party>
    <keyword>hypoxia</keyword>
    <keyword>hysteroscopy</keyword>
    <keyword>Overweight or Obesity</keyword>
    <keyword>remimazolam</keyword>
    <keyword>propofol</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Overweight</mesh_term>
      <mesh_term>Hypoxia</mesh_term>
    </condition_browse>
    <intervention_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Propofol</mesh_term>
    </intervention_browse>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
    </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/NCT06004843
  org study id: LY2023-115-A
  nct id: NCT06004843
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  is us export: No
  Hypoxia is a common adverse event during sedated hysteroscopy for assisted reproduction, and
        it is more likely to occur in overweight or obese patients. In sedated gastroscopy, the
        incidence of hypoxia with remimazolam is lower than that with propofol. The present study is
        a single-center, randomized, single-blind, controlled clinical trial. Overweight or obese
        patients undergoing sedated hysteroscopy for diagnosis and treatment, with ASA grade I or II,
        were selected as subjects and randomly divided into an experimental group and a control
        group, with 300 subjects in each group. Sedation induction and maintenance are performed
        using remimazolam or propofol combined with remifentanil, respectively, to compare the
        incidence of hypoxia during surgery between the two groups of patients.
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Prevention
  masking: Single (Participant)
  measure: The incidence of hypoxia
  time frame: Participants will be followed for the duration of their hospital stay, with an expected average of about 2 hours.
  description: 75%≤ SpO2% ≤89% for<60s
  measure: The incidence of sub-clinical respiratory depression
  time frame: Participants will be followed for the duration of their hospital stay, with an expected average of about 2 hours.
  description: 90%≤ SpO2<95%
  measure: The incidence of severe hypoxia
  time frame: Participants will be followed for the duration of their hospital stay, with an expected average of about 2 hours.
  description: SpO2<75% or 75%≤ SpO2≤89% for≥60s
  measure: The incidence of other adverse events
  time frame: Participants will be followed for the duration of their hospital stay, with an expected average of about 2 hours.
  description: Other adverse events recorded by tools proposed by the World Society of Intravenous Anesthesia International Sedation Task Force
  arm group label: Remimazolam
  arm group type: Experimental
  description: In this group, participants are sedated with remimazolam and remifentanil.
  arm group label: propofol
  arm group type: Active Comparator
  description: In this group, participants are sedated with propofol and remifentanil.
  intervention type: Drug
  intervention name: remimazolam
  description: in this group,patients are treated with remimazolam and remifentanil for reduced sedation.
  arm group label: Remimazolam
  intervention type: Drug
  intervention name: Propofol
  description: in this group,patients are treated with propofol and remifentanil for reduced sedation.
  arm group label: propofol
  criteria: 
  gender: Female
  gender based: Yes
  minimum age: 20 Years
  maximum age: 50 Years
  healthy volunteers: No
  last name: diansan su, Dr
  phone: +862168383702
  email: diansansu@yahoo.com
  last name: yanhua he, B.S
  phone: +862168383702
  email: 2339570124@qq.com
  facility: 
  contact: 
  country: China
  responsible party type: Principal Investigator
  investigator affiliation: RenJi Hospital
  investigator full name: diansan su
  investigator title: Vice chair of the department of anesthesiology
  mesh term: Overweight
  mesh term: Hypoxia
  mesh term: Propofol
  sharing ipd: No