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/NCT05980117</url>
    </required_header>
    <id_info>
      <org_study_id>22-001570</org_study_id>
      <nct_id>NCT05980117</nct_id>
    </id_info>
    <brief_title>Remimazolam for Cataract Surgery</brief_title>
    <official_title>Comparison of Remimazolam vs. Midazolam for Sedation During Cataract Surgery</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>University of California, Los Angeles</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>University of California, Los Angeles</source>
    <oversight_info>
      <has_dmc>No</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>
        The goal of this study is to assess any post operative cognitive changes following&#xD;
        benzodiazepine administration during cataract surgery. The investigators will compare effects&#xD;
        of Midazolam vs. Remimazolam on cognition at the time of discharge from the post operative&#xD;
        care unit and the next day following surgery.&#xD;
  &#xD;
        Cognitive changes will be assessed by administration of Montreal Cognitive Assessment (MoCA).&#xD;
  &#xD;
        Participants will:&#xD;
  &#xD;
          1. Complete MoCA testing prior to surgery&#xD;
  &#xD;
          2. Randomize in either Midazolam or study drug Remimazolam&#xD;
  &#xD;
          3. Complete MoCA testing after surgery at the time of discharge in the post anesthesia care&#xD;
             unit and the next day of surgery at the time of post operative surgical visit.&#xD;
  &#xD;
          4. Complete Patient Satisfaction Survey at the time of discharge from the Post Anesthesia&#xD;
             Care Unit (PACU)&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Cataract surgery (clouded natural lens of eye removed and clear artificial lens implanted) is&#xD;
        the most common eye surgery performed in elderly patients. Although cataract surgery is a&#xD;
        minor surgery, many patients are anxious and therefore benzodiazepine such as midazolam is&#xD;
        administered during surgery to allay a patient's anxiety.&#xD;
  &#xD;
        The purpose of this study is to look at any difference in postoperative cognitive changes as&#xD;
        well as recovery times in the PACU following administration of midazolam or remimazolam.&#xD;
  &#xD;
        Patients will be asked to participate in a clinical trial where they will be randomly&#xD;
        assigned to midazolam or remimazolam group. Cognitive changes will be assessed by&#xD;
        administration of MoCA test. MoCA test is a validated, objective short (about 10-15 minutes)&#xD;
        screening tool for detection of mild neurocognitive dysfunction. Given the short half life of&#xD;
        remimazolam, investigators hypothesize that any cognitive changes will be less with&#xD;
        remimazolam compared to midazolam.&#xD;
  &#xD;
        Patients will be asked to complete MoCA prior to surgery, in the recovery room following&#xD;
        surgery, and the next day during their post-operative clinic visit. In addition, patients&#xD;
        will be asked to rate their satisfaction of their anesthetic during their surgery.&#xD;
  &#xD;
        The participant will be in this research study from the day of surgery until the first&#xD;
        post-operative visit, the following day.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">September 2023</start_date>
    <completion_date type="Anticipated">May 2024</completion_date>
    <primary_completion_date type="Anticipated">February 2024</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>Patients will be randomized to the intervention group receiving Remimazolam or to the control group receiving Midazolam.</intervention_model_description>
      <primary_purpose>Treatment</primary_purpose>
      <masking>Single (Participant)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Change in MoCA score following surgery in the PACU and post operative day 1.</measure>
      <time_frame>Immediately following surgery in the PACU and post operative day 1.</time_frame>
      <description>Montreal Cognitive Assessment (MoCA) test. A numerical scale is used for scoring. 18-25 = mild cognitive impairment, 10-17= moderate cognitive impairment and less than 10= severe cognitive impairment</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Change in MoCA Scores in PACU and the next day between midazolam and remimazolam group.</measure>
      <time_frame>Immediately following surgery in the PACU, and post operative day 1.</time_frame>
      <description>Montreal Cognitive Assessment (MoCA) test. The following ranges may be used to grade severity: A numerical scale is used for scoring. 18-25 = mild cognitive impairment, 10-17= moderate cognitive impairment and less than 10= severe cognitive impairment.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Length of postoperative stay</measure>
      <time_frame>Postop day 0 (day of surgery) until discharge from the hospital, usually on postop day 1 (an average of 1 day).</time_frame>
      <description>Duration from the time of admission to readiness for discharge from the PACU. The following ranges may be used to grade severity:</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Surgeon Satisfaction</measure>
      <time_frame>Intraoperatively to postoperatively in the ICU, and expected average of 1 hour.</time_frame>
      <description>Surgeon satisfaction score will be assessed post-surgery as measured by a 5-point scale with 1 = Strongly Disagree , 2 = Disagree , 3 = Neither Agree nor Disagree, 4 = Agree, 5 = Strongly Agree.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Patient Satisfaction</measure>
      <time_frame>Day of surgery</time_frame>
      <description>Patient satisfaction score will be assessed at the time of discharge by a 5 point scale with 1 = Disagree Strongly , 2 = Disagree Somewhat , 3 = Neither Agree or Disagree, 4 = Agree Somewhat, 5 = Agree Strongly.</description>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">120</enrollment>
    <condition>Cataract Surgery</condition>
    <condition>Cognitive Impairment</condition>
    <arm_group>
      <arm_group_label>Intervention</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Patients assigned to the study group will receive Remimazolam.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Control</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>Patients assigned to the control group will receive Midazolam.</description>
    </arm_group>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Remimazolam</intervention_name>
      <description>Remimazolam (1.0mg IV) titrated to modified observer's assessment of sedation score of 3 -4 during cataract surgery.</description>
      <arm_group_label>Intervention</arm_group_label>
      <other_name>Byfavo</other_name>
    </intervention>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Midazolam</intervention_name>
      <description>Midazolam (0.5-2mg IV) titrated to modified observer's assessment of sedation score of 3 - 4 during cataract surgery.</description>
      <arm_group_label>Control</arm_group_label>
      <other_name>Versed</other_name>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            1. Adult patients age &gt; 65 years undergoing first eye cataract surgery under local&#xD;
               topical anesthesia at the University of California, Los Angeles (UCLA).&#xD;
  &#xD;
            2. Both male and female patients&#xD;
  &#xD;
            3. American Society of Anesthesiologists Class 2, 3, and 4.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            1. Patients who are unable to consent for the study&#xD;
  &#xD;
            2. Patients who are unable to cooperate with the cognitive assessment such as patients&#xD;
               with significant visual, auditory, language or other impairment.&#xD;
  &#xD;
            3. Patients who are unable to understand simple English commands.&#xD;
  &#xD;
            4. Patients who do not wish to have benzodiazepine medication during surgery&#xD;
  &#xD;
            5. Patients with a history of severe hypersensitivity reaction to dextran 40 or products&#xD;
               containing dextran 40.&#xD;
  &#xD;
            6. Patients with chronic pain on opiates.&#xD;
  &#xD;
            7. Patients with a history of drug, alcohol abuse/dependence.&#xD;
  &#xD;
            8. Patients with BMI &gt; 40.&#xD;
  &#xD;
            9. Patients with obstructive sleep apnea (moderate to severe).&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>65 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Zhuang Fang, MD</last_name>
      <role>Principal Investigator</role>
      <affiliation>University of California, Los Angeles</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Zhuang T Fang, MD</last_name>
      <phone>310-267-8946</phone>
      <email>ZFang@mednet.ucla.edu</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Stephanie-Dee Sarovich, BS</last_name>
      <phone>424-832-6842</phone>
      <email>ssarovich@mednet.ucla.edu</email>
    </overall_contact_backup>
    <location>
      <facility>
        <name>Ronald Reagan UCLA Medical Center, Department of Anesthesiology &amp; Perioperative Medicine</name>
        <address>
          <city>Los Angeles</city>
          <state>California</state>
          <zip>90095</zip>
          <country>United States</country>
        </address>
      </facility>
      <contact>
        <last_name>Stephanie-Dee Sarovich, B.S.</last_name>
        <phone>424-832-6842</phone>
        <email>ssarovich@mednet.ucla.edu</email>
      </contact>
      <investigator>
        <last_name>Gundappa Neelakanta, M.D.</last_name>
        <role>Sub-Investigator</role>
      </investigator>
    </location>
    <location_countries>
      <country>United States</country>
    </location_countries>
    <reference>
      <citation>Rabinowitz LE, Lamper L, Tendler JM, Schlesinger JM, Vera N. Preventing Adverse Events in Cataract Surgery. Anesth Analg. 2018 Oct;127(4):e66. doi: 10.1213/ANE.0000000000003655. No abstract available.</citation>
      <PMID>30059403</PMID>
    </reference>
    <reference>
      <citation>Chung F, Lavelle PA, McDonald S, Chung A, McDonald NJ. Cognitive impairment after neuroleptanalgesia in cataract surgery. Anesth Analg. 1989 May;68(5):614-8.</citation>
      <PMID>2719292</PMID>
    </reference>
    <reference>
      <citation>Evered LA, Silbert BS, Scott DA, Maruff P, Ames D, Choong PF. Preexisting cognitive impairment and mild cognitive impairment in subjects presenting for total hip joint replacement. Anesthesiology. 2011 Jun;114(6):1297-304. doi: 10.1097/ALN.0b013e31821b1aab.</citation>
      <PMID>21502855</PMID>
    </reference>
    <reference>
      <citation>Nasreddine ZS, Phillips NA, Bedirian V, Charbonneau S, Whitehead V, Collin I, Cummings JL, Chertkow H. The Montreal Cognitive Assessment, MoCA: a brief screening tool for mild cognitive impairment. J Am Geriatr Soc. 2005 Apr;53(4):695-9. doi: 10.1111/j.1532-5415.2005.53221.x. Erratum In: J Am Geriatr Soc. 2019 Sep;67(9):1991.</citation>
      <PMID>15817019</PMID>
    </reference>
    <reference>
      <citation>Chernik DA, Gillings D, Laine H, Hendler J, Silver JM, Davidson AB, Schwam EM, Siegel JL. Validity and reliability of the Observer's Assessment of Alertness/Sedation Scale: study with intravenous midazolam. J Clin Psychopharmacol. 1990 Aug;10(4):244-51.</citation>
      <PMID>2286697</PMID>
    </reference>
    <reference>
      <citation>Tan Y, Ouyang W, Tang Y, Fang N, Fang C, Quan C. Effect of remimazolam tosilate on early cognitive function in elderly patients undergoing upper gastrointestinal endoscopy. J Gastroenterol Hepatol. 2022 Mar;37(3):576-583. doi: 10.1111/jgh.15761. Epub 2022 Jan 3.</citation>
      <PMID>34907594</PMID>
    </reference>
    <verification_date>September 2023</verification_date>
    <study_first_submitted>June 21, 2023</study_first_submitted>
    <study_first_submitted_qc>August 4, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 7, 2023</study_first_posted>
    <last_update_submitted>September 14, 2023</last_update_submitted>
    <last_update_submitted_qc>September 14, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 18, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>University of California, Los Angeles</investigator_affiliation>
      <investigator_full_name>Zhuang T. Fang, MD</investigator_full_name>
      <investigator_title>Principal Investigator</investigator_title>
    </responsible_party>
    <keyword>Midazolam</keyword>
    <keyword>Remimazolam</keyword>
    <keyword>Outcomes</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Cataract</mesh_term>
    </condition_browse>
    <intervention_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Midazolam</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/NCT05980117
  org study id: 22-001570
  nct id: NCT05980117
  lead sponsor: 
  has dmc: No
  is fda regulated drug: Yes
  is fda regulated device: No
  is us export: Yes
  The goal of this study is to assess any post operative cognitive changes following
        benzodiazepine administration during cataract surgery. The investigators will compare effects
        of Midazolam vs. Remimazolam on cognition at the time of discharge from the post operative
        care unit and the next day following surgery.
  
        Cognitive changes will be assessed by administration of Montreal Cognitive Assessment (MoCA).
  
        Participants will:
  
          1. Complete MoCA testing prior to surgery
  
          2. Randomize in either Midazolam or study drug Remimazolam
  
          3. Complete MoCA testing after surgery at the time of discharge in the post anesthesia care
             unit and the next day of surgery at the time of post operative surgical visit.
  
          4. Complete Patient Satisfaction Survey at the time of discharge from the Post Anesthesia
             Care Unit (PACU)
  Cataract surgery (clouded natural lens of eye removed and clear artificial lens implanted) is
        the most common eye surgery performed in elderly patients. Although cataract surgery is a
        minor surgery, many patients are anxious and therefore benzodiazepine such as midazolam is
        administered during surgery to allay a patient's anxiety.
  
        The purpose of this study is to look at any difference in postoperative cognitive changes as
        well as recovery times in the PACU following administration of midazolam or remimazolam.
  
        Patients will be asked to participate in a clinical trial where they will be randomly
        assigned to midazolam or remimazolam group. Cognitive changes will be assessed by
        administration of MoCA test. MoCA test is a validated, objective short (about 10-15 minutes)
        screening tool for detection of mild neurocognitive dysfunction. Given the short half life of
        remimazolam, investigators hypothesize that any cognitive changes will be less with
        remimazolam compared to midazolam.
  
        Patients will be asked to complete MoCA prior to surgery, in the recovery room following
        surgery, and the next day during their post-operative clinic visit. In addition, patients
        will be asked to rate their satisfaction of their anesthetic during their surgery.
  
        The participant will be in this research study from the day of surgery until the first
        post-operative visit, the following day.
  allocation: Randomized
  intervention model: Parallel Assignment
  intervention model description: Patients will be randomized to the intervention group receiving Remimazolam or to the control group receiving Midazolam.
  primary purpose: Treatment
  masking: Single (Participant)
  measure: Change in MoCA score following surgery in the PACU and post operative day 1.
  time frame: Immediately following surgery in the PACU and post operative day 1.
  description: Montreal Cognitive Assessment (MoCA) test. A numerical scale is used for scoring. 18-25 = mild cognitive impairment, 10-17= moderate cognitive impairment and less than 10= severe cognitive impairment
  measure: Change in MoCA Scores in PACU and the next day between midazolam and remimazolam group.
  time frame: Immediately following surgery in the PACU, and post operative day 1.
  description: Montreal Cognitive Assessment (MoCA) test. The following ranges may be used to grade severity: A numerical scale is used for scoring. 18-25 = mild cognitive impairment, 10-17= moderate cognitive impairment and less than 10= severe cognitive impairment.
  measure: Length of postoperative stay
  time frame: Postop day 0 (day of surgery) until discharge from the hospital, usually on postop day 1 (an average of 1 day).
  description: Duration from the time of admission to readiness for discharge from the PACU. The following ranges may be used to grade severity:
  measure: Surgeon Satisfaction
  time frame: Intraoperatively to postoperatively in the ICU, and expected average of 1 hour.
  description: Surgeon satisfaction score will be assessed post-surgery as measured by a 5-point scale with 1 = Strongly Disagree , 2 = Disagree , 3 = Neither Agree nor Disagree, 4 = Agree, 5 = Strongly Agree.
  measure: Patient Satisfaction
  time frame: Day of surgery
  description: Patient satisfaction score will be assessed at the time of discharge by a 5 point scale with 1 = Disagree Strongly , 2 = Disagree Somewhat , 3 = Neither Agree or Disagree, 4 = Agree Somewhat, 5 = Agree Strongly.
  arm group label: Intervention
  arm group type: Experimental
  description: Patients assigned to the study group will receive Remimazolam.
  arm group label: Control
  arm group type: Active Comparator
  description: Patients assigned to the control group will receive Midazolam.
  intervention type: Drug
  intervention name: Remimazolam
  description: Remimazolam (1.0mg IV) titrated to modified observer's assessment of sedation score of 3 -4 during cataract surgery.
  arm group label: Intervention
  other name: Byfavo
  intervention type: Drug
  intervention name: Midazolam
  description: Midazolam (0.5-2mg IV) titrated to modified observer's assessment of sedation score of 3 - 4 during cataract surgery.
  arm group label: Control
  other name: Versed
  criteria: 
  gender: All
  minimum age: 65 Years
  maximum age: N/A
  healthy volunteers: No
  last name: Zhuang Fang, MD
  role: Principal Investigator
  affiliation: University of California, Los Angeles
  last name: Zhuang T Fang, MD
  phone: 310-267-8946
  email: ZFang@mednet.ucla.edu
  last name: Stephanie-Dee Sarovich, BS
  phone: 424-832-6842
  email: ssarovich@mednet.ucla.edu
  facility: 
  contact: 
  investigator: 
  country: United States
  citation: Rabinowitz LE, Lamper L, Tendler JM, Schlesinger JM, Vera N. Preventing Adverse Events in Cataract Surgery. Anesth Analg. 2018 Oct;127(4):e66. doi: 10.1213/ANE.0000000000003655. No abstract available.
  PMID: 30059403
  citation: Chung F, Lavelle PA, McDonald S, Chung A, McDonald NJ. Cognitive impairment after neuroleptanalgesia in cataract surgery. Anesth Analg. 1989 May;68(5):614-8.
  PMID: 2719292
  citation: Evered LA, Silbert BS, Scott DA, Maruff P, Ames D, Choong PF. Preexisting cognitive impairment and mild cognitive impairment in subjects presenting for total hip joint replacement. Anesthesiology. 2011 Jun;114(6):1297-304. doi: 10.1097/ALN.0b013e31821b1aab.
  PMID: 21502855
  citation: Nasreddine ZS, Phillips NA, Bedirian V, Charbonneau S, Whitehead V, Collin I, Cummings JL, Chertkow H. The Montreal Cognitive Assessment, MoCA: a brief screening tool for mild cognitive impairment. J Am Geriatr Soc. 2005 Apr;53(4):695-9. doi: 10.1111/j.1532-5415.2005.53221.x. Erratum In: J Am Geriatr Soc. 2019 Sep;67(9):1991.
  PMID: 15817019
  citation: Chernik DA, Gillings D, Laine H, Hendler J, Silver JM, Davidson AB, Schwam EM, Siegel JL. Validity and reliability of the Observer's Assessment of Alertness/Sedation Scale: study with intravenous midazolam. J Clin Psychopharmacol. 1990 Aug;10(4):244-51.
  PMID: 2286697
  citation: Tan Y, Ouyang W, Tang Y, Fang N, Fang C, Quan C. Effect of remimazolam tosilate on early cognitive function in elderly patients undergoing upper gastrointestinal endoscopy. J Gastroenterol Hepatol. 2022 Mar;37(3):576-583. doi: 10.1111/jgh.15761. Epub 2022 Jan 3.
  PMID: 34907594
  responsible party type: Principal Investigator
  investigator affiliation: University of California, Los Angeles
  investigator full name: Zhuang T. Fang, MD
  investigator title: Principal Investigator
  mesh term: Cataract
  mesh term: Midazolam
  sharing ipd: No