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/NCT05994547</url>
    </required_header>
    <id_info>
      <org_study_id>Remimazolam Vs midazolam</org_study_id>
      <nct_id>NCT05994547</nct_id>
    </id_info>
    <brief_title>Efficacy and Safety of Remimazolam Compared With Midazolam During Bronchoscopy:Randomised Controlled Trial</brief_title>
    <official_title>Safety and Efficacy of Remimazolam Compared With Midazolam During Bronchoscopy: A Single Center, Randomized Controlled Study</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Chungbuk National University Hospital</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Chungbuk National University 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>
    </oversight_info>
    <brief_summary>
      <textblock>
        Objectives: Although remimazolam is an ultra-short-acting benzodiazepine with a shorter&#xD;
        elimination half-life and faster recovery time than midazolam, studies evaluating its safety&#xD;
        and efficacy during bronchoscopy are limited. This study compared the safety and efficacy of&#xD;
        remimazolam with that of midazolam for bronchoscopy.&#xD;
  &#xD;
        Design: A single-center, prospective randomized parallel-group study&#xD;
  &#xD;
        Setting: Chungbuk National University Hospital, April 2022-June 2023.&#xD;
  &#xD;
        Participants: One hundred patients were enrolled; 51 were randomly assigned to the midazolam&#xD;
        group and 49 to the remimazolam group. Respiratory nurse specialists performed the&#xD;
        randomization.&#xD;
  &#xD;
        Interventions: Oral and laryngeal anesthesia was induced using a 4% lidocaine nebulizer prior&#xD;
        to sedation. The vocal cords and lower airway tract were anesthetized.&#xD;
  &#xD;
        Patients aged &lt;60 years or weighing &gt;50 kg received 3 mg intravenous midazolam or 5 mg&#xD;
        remimazolam. Patients aged ≥60 years or weighing &lt;50 kg received 2 mg intravenous midazolam&#xD;
        or 3 mg remimazolam. Bronchoscopy was performed under adequate sedation (MOAA/S≤3)&#xD;
  &#xD;
        Main outcome measures: The primary outcome was the time from the end of the procedure to full&#xD;
        alertness. Secondary outcomes were procedural time parameters, satisfaction profiles, and&#xD;
        adverse effects.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Completed</overall_status>
    <start_date type="Actual">April 14, 2022</start_date>
    <completion_date type="Actual">June 15, 2023</completion_date>
    <primary_completion_date type="Actual">June 15, 2023</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>Double (Participant, Investigator)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>the time from the end of the procedure to full alertness in both groups.</measure>
      <time_frame>up to 2 hours (MOAA/S had recovered to 5 after the procedure had been completed.)</time_frame>
      <description>The Time for patient to recover Modified Observer's Assessment of Alertness and Sedation (MOAA/S) scores to 5 after end of bronchoscopy&#xD;
  MOAA/S scores: 5 = Responds readily to name spoken in normal tone [alert], 4 =Lethargic response to name spoken in normal tone, 3 = Responds only after name is called loudly and/or repeatedly, 2 = Responds only after mild prodding or shaking, 1 = Responds only after painful trapezius squeeze, 0 = Does not respond to painful trapezius squeeze.&#xD;
  MOAA/S scores were assessed by the investigators.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>the time taken to reach peak sedation</measure>
      <time_frame>up to 30 minutes (the time to the start of the procedure after the administration of the first dose of medication)</time_frame>
      <description>The degree of sedation was measured using the Modified Observer's Alertness/Sedation scale (MOAA/S), and bronchoscopy was performed under adequate sedation (MOAA/S≤3)</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>physician satisfaction after the procedure</measure>
      <time_frame>up to 1day</time_frame>
      <description>Physician satisfaction with sedation was expressed as a score ranging from -5 to 5 after completion of the procedure (-5 = not satisfied at all, 5 = maximally satisfied).</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>patient satisfaction after the procedure</measure>
      <time_frame>up to 1day</time_frame>
      <description>Patient satisfaction was measured using a visual analog scale (0 = intolerable, 10 = free from inconvenience).</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>difference between the adverse effects that occurred after bronchoscopy in the midazolam and remimazolam groups.</measure>
      <time_frame>up to 30days (the first dose to the end of the procedure was defined as the time from the first sedative drug administration to mouth exit.)</time_frame>
      <description>adverse effects that occur during and after the procedure</description>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Actual">100</enrollment>
    <condition>Bronchoscopy</condition>
    <condition>Remimazolam</condition>
    <arm_group>
      <arm_group_label>Midazolam</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Patients aged &lt;60 years or weighing &gt;50 kg were randomly assigned to receive 3 mg intravenous midazolam. In contrast, those aged ≥60 years or with a body weight of &lt;50 kg were assigned 2 mg intravenous.&#xD;
  If adequate sedation was not achieved after the initial sedative administration, additional midazolam (0.5 mg) was administered at intervals of 3-4 min, at the discretion of the physician.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Remimazolam</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>Patients aged &lt;60 years or weighing &gt;50 kg were randomly assigned to receive 5 mg remimazolam. In contrast, those aged ≥60 years or with a body weight of &lt;50 kg were assigned intravenous 3 mg remimazolam.&#xD;
  If adequate sedation was not achieved after the initial sedative administration, additional remimazolam (2.5 mg) was administered at intervals of 3-4 min, at the discretion of the physician.</description>
    </arm_group>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Byfavo</intervention_name>
      <description>For induction and maintenance of sedation</description>
      <arm_group_label>Remimazolam</arm_group_label>
      <other_name>Remimazolam</other_name>
    </intervention>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Midazolam</intervention_name>
      <description>For induction and maintenance of sedation</description>
      <arm_group_label>Midazolam</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  aged ≥18 years who required diagnostic or therapeutic bronchoscopy and agreed to&#xD;
               participate&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  1) pregnancy, 2) moderate-to-severe hepatic impairment and lactose intolerance 3)&#xD;
               mechanical ventilation 4) history of tracheostomy 5) poor patient cooperation&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <location>
      <facility>
        <name>Chungbuk National University Hospital</name>
        <address>
          <city>Cheongju-si</city>
          <state>Chungcheongbuk-do</state>
          <zip>28644</zip>
          <country>Korea, Republic of</country>
        </address>
      </facility>
    </location>
    <location_countries>
      <country>Korea, Republic of</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>July 31, 2023</study_first_submitted>
    <study_first_submitted_qc>August 8, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 16, 2023</study_first_posted>
    <last_update_submitted>August 8, 2023</last_update_submitted>
    <last_update_submitted_qc>August 8, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 16, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Chungbuk National University Hospital</investigator_affiliation>
      <investigator_full_name>Bumhee Yang, MD</investigator_full_name>
      <investigator_title>Associator professor M.D. PhD.</investigator_title>
    </responsible_party>
    <keyword>Remimazolam</keyword>
    <keyword>midazolam</keyword>
    <keyword>safety</keyword>
    <keyword>efficacy</keyword>
    <intervention_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Midazolam</mesh_term>
    </intervention_browse>
    <!-- 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/NCT05994547
  org study id: Remimazolam Vs midazolam
  nct id: NCT05994547
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  Objectives: Although remimazolam is an ultra-short-acting benzodiazepine with a shorter
        elimination half-life and faster recovery time than midazolam, studies evaluating its safety
        and efficacy during bronchoscopy are limited. This study compared the safety and efficacy of
        remimazolam with that of midazolam for bronchoscopy.
  
        Design: A single-center, prospective randomized parallel-group study
  
        Setting: Chungbuk National University Hospital, April 2022-June 2023.
  
        Participants: One hundred patients were enrolled; 51 were randomly assigned to the midazolam
        group and 49 to the remimazolam group. Respiratory nurse specialists performed the
        randomization.
  
        Interventions: Oral and laryngeal anesthesia was induced using a 4% lidocaine nebulizer prior
        to sedation. The vocal cords and lower airway tract were anesthetized.
  
        Patients aged <60 years or weighing >50 kg received 3 mg intravenous midazolam or 5 mg
        remimazolam. Patients aged ≥60 years or weighing <50 kg received 2 mg intravenous midazolam
        or 3 mg remimazolam. Bronchoscopy was performed under adequate sedation (MOAA/S≤3)
  
        Main outcome measures: The primary outcome was the time from the end of the procedure to full
        alertness. Secondary outcomes were procedural time parameters, satisfaction profiles, and
        adverse effects.
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Treatment
  masking: Double (Participant, Investigator)
  measure: the time from the end of the procedure to full alertness in both groups.
  time frame: up to 2 hours (MOAA/S had recovered to 5 after the procedure had been completed.)
  description: The Time for patient to recover Modified Observer's Assessment of Alertness and Sedation (MOAA/S) scores to 5 after end of bronchoscopy
  MOAA/S scores: 5 = Responds readily to name spoken in normal tone [alert], 4 =Lethargic response to name spoken in normal tone, 3 = Responds only after name is called loudly and/or repeatedly, 2 = Responds only after mild prodding or shaking, 1 = Responds only after painful trapezius squeeze, 0 = Does not respond to painful trapezius squeeze.
  MOAA/S scores were assessed by the investigators.
  measure: the time taken to reach peak sedation
  time frame: up to 30 minutes (the time to the start of the procedure after the administration of the first dose of medication)
  description: The degree of sedation was measured using the Modified Observer's Alertness/Sedation scale (MOAA/S), and bronchoscopy was performed under adequate sedation (MOAA/S≤3)
  measure: physician satisfaction after the procedure
  time frame: up to 1day
  description: Physician satisfaction with sedation was expressed as a score ranging from -5 to 5 after completion of the procedure (-5 = not satisfied at all, 5 = maximally satisfied).
  measure: patient satisfaction after the procedure
  time frame: up to 1day
  description: Patient satisfaction was measured using a visual analog scale (0 = intolerable, 10 = free from inconvenience).
  measure: difference between the adverse effects that occurred after bronchoscopy in the midazolam and remimazolam groups.
  time frame: up to 30days (the first dose to the end of the procedure was defined as the time from the first sedative drug administration to mouth exit.)
  description: adverse effects that occur during and after the procedure
  arm group label: Midazolam
  arm group type: Experimental
  description: Patients aged <60 years or weighing >50 kg were randomly assigned to receive 3 mg intravenous midazolam. In contrast, those aged ≥60 years or with a body weight of <50 kg were assigned 2 mg intravenous.
  If adequate sedation was not achieved after the initial sedative administration, additional midazolam (0.5 mg) was administered at intervals of 3-4 min, at the discretion of the physician.
  arm group label: Remimazolam
  arm group type: Active Comparator
  description: Patients aged <60 years or weighing >50 kg were randomly assigned to receive 5 mg remimazolam. In contrast, those aged ≥60 years or with a body weight of <50 kg were assigned intravenous 3 mg remimazolam.
  If adequate sedation was not achieved after the initial sedative administration, additional remimazolam (2.5 mg) was administered at intervals of 3-4 min, at the discretion of the physician.
  intervention type: Drug
  intervention name: Byfavo
  description: For induction and maintenance of sedation
  arm group label: Remimazolam
  other name: Remimazolam
  intervention type: Drug
  intervention name: Midazolam
  description: For induction and maintenance of sedation
  arm group label: Midazolam
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: No
  facility: 
  country: Korea, Republic of
  responsible party type: Principal Investigator
  investigator affiliation: Chungbuk National University Hospital
  investigator full name: Bumhee Yang, MD
  investigator title: Associator professor M.D. PhD.
  mesh term: Midazolam