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/NCT05990673</url>
    </required_header>
    <id_info>
      <org_study_id>XJH-A-20230606</org_study_id>
      <nct_id>NCT05990673</nct_id>
    </id_info>
    <brief_title>Dose of Remi in Children</brief_title>
    <acronym>DRINK</acronym>
    <official_title>Determination of the 50% and 95% Effective Dose of Remimazolam for Intravenous Anesthesia Induction in Pediatric Patients</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Zhihong LU</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Air Force Military Medical University, China</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>
    </oversight_info>
    <brief_summary>
      <textblock>
        Remimazolam has demonstrated the potential as a valuable medication for procedural sedation&#xD;
        and general anesthesia. However, the effective dosage of remimazolam in pediatric patients is&#xD;
        still unknown.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">August 10, 2023</start_date>
    <completion_date type="Anticipated">September 10, 2023</completion_date>
    <primary_completion_date type="Anticipated">September 10, 2023</primary_completion_date>
    <phase>N/A</phase>
    <study_type>Interventional</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <allocation>N/A</allocation>
      <intervention_model>Sequential Assignment</intervention_model>
      <primary_purpose>Treatment</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>half effective dosage</measure>
      <time_frame>from injection of remimazolam to loss of consciousness, at an average of 5 minutes</time_frame>
      <description>the dosage by which half of the patients will be sedated</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>95% effective dosage</measure>
      <time_frame>from injection of remimazolam to loss of consciousness, at an average of 5 minutes</time_frame>
      <description>the dosage by which 95% of the patients will be sedated</description>
    </secondary_outcome>
    <number_of_arms>1</number_of_arms>
    <enrollment type="Anticipated">25</enrollment>
    <condition>Anesthesia</condition>
    <arm_group>
      <arm_group_label>remimazolam</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>remimazolam is given for anesthesia induction</description>
    </arm_group>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Remimazolam</intervention_name>
      <description>remimazolam is given intravenously</description>
      <arm_group_label>remimazolam</arm_group_label>
      <other_name>remimazolam besylate</other_name>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  age from 3 to 12 years old&#xD;
  &#xD;
            -  patients scheduled for surgery under general anesthesia&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  American Society of Anesthesiologists status &gt;=Ⅲ&#xD;
  &#xD;
            -  Body mass index&gt;=28kg/m2&#xD;
  &#xD;
            -  patients who cannot cooperate with intravenous anesthesia induction&#xD;
  &#xD;
            -  patients with risk of difficult airway&#xD;
  &#xD;
            -  patients who are allergic to benzodiazepines&#xD;
  &#xD;
            -  patients with delayed neurologic function&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>3 Years</minimum_age>
      <maximum_age>12 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <results_reference>
      <citation>Tan H, Lou AF, Wu JE, Chen XZ, Qian XW. Determination of the 50% and 95% Effective Dose of Remimazolam Combined with Propofol for Intravenous Sedation During Day-Surgery Hysteroscopy. Drug Des Devel Ther. 2023 Jun 13;17:1753-1761. doi: 10.2147/DDDT.S406514. eCollection 2023.</citation>
      <PMID>37333966</PMID>
    </results_reference>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 7, 2023</study_first_submitted>
    <study_first_submitted_qc>August 7, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 14, 2023</study_first_posted>
    <last_update_submitted>August 7, 2023</last_update_submitted>
    <last_update_submitted_qc>August 7, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 14, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor-Investigator</responsible_party_type>
      <investigator_affiliation>Air Force Military Medical University, China</investigator_affiliation>
      <investigator_full_name>Zhihong LU</investigator_full_name>
      <investigator_title>Associate professor</investigator_title>
    </responsible_party>
    <keyword>general anesthesia</keyword>
    <keyword>anesthesia induction</keyword>
    <keyword>remimazolam</keyword>
    <patient_data>
      <sharing_ipd>Undecided</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/NCT05990673
  org study id: XJH-A-20230606
  nct id: NCT05990673
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  Remimazolam has demonstrated the potential as a valuable medication for procedural sedation
        and general anesthesia. However, the effective dosage of remimazolam in pediatric patients is
        still unknown.
  allocation: N/A
  intervention model: Sequential Assignment
  primary purpose: Treatment
  masking: None (Open Label)
  measure: half effective dosage
  time frame: from injection of remimazolam to loss of consciousness, at an average of 5 minutes
  description: the dosage by which half of the patients will be sedated
  measure: 95% effective dosage
  time frame: from injection of remimazolam to loss of consciousness, at an average of 5 minutes
  description: the dosage by which 95% of the patients will be sedated
  arm group label: remimazolam
  arm group type: Experimental
  description: remimazolam is given for anesthesia induction
  intervention type: Drug
  intervention name: Remimazolam
  description: remimazolam is given intravenously
  arm group label: remimazolam
  other name: remimazolam besylate
  criteria: 
  gender: All
  minimum age: 3 Years
  maximum age: 12 Years
  healthy volunteers: No
  citation: Tan H, Lou AF, Wu JE, Chen XZ, Qian XW. Determination of the 50% and 95% Effective Dose of Remimazolam Combined with Propofol for Intravenous Sedation During Day-Surgery Hysteroscopy. Drug Des Devel Ther. 2023 Jun 13;17:1753-1761. doi: 10.2147/DDDT.S406514. eCollection 2023.
  PMID: 37333966
  responsible party type: Sponsor-Investigator
  investigator affiliation: Air Force Military Medical University, China
  investigator full name: Zhihong LU
  investigator title: Associate professor
  sharing ipd: Undecided