<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/NCT02232139</url>
  </required_header>
  <id_info>
    <org_study_id>BR-87/13-1</org_study_id>
    <secondary_id>EK-BR-87/13-1</secondary_id>
    <nct_id>NCT02232139</nct_id>
  </id_info>
  <brief_title>Measurement of Psychomotor Recovery After Anesthesia Using 4CRT</brief_title>
  <acronym>4CRT</acronym>
  <official_title>Measurement of Psychomotor Function Recovery in Patients After General Anesthesia Using 4-Choice Reaction Time Test</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University Medicine Greifswald</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Department of Anesthesiology, Hospital Dresden-Friedrichstadt, Dresden, Germany</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>University Medicine Greifswald</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The aim of the investigation is to validate the SmartPhone-based 4-Reaction Choice Time Test&#xD;
      (4CRT) as a measure for recovery of the psychomotor function in patients after general&#xD;
      anesthesia. One hundred female patients, scheduled to ambulatory gynecological surgery in&#xD;
      general anesthesia, will be randomized to the group with pharmacological anxiolytic&#xD;
      premedication with midazolam (N=50) and to the group without midazolam (N=50). All patients&#xD;
      will be monitored using 4CRT before and after standardized general anesthesia. The reaction&#xD;
      time, measured with 4CRT is the primary outcome parameter of the investigation.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      4CRT is a classical psychological test, used to measure the psychomotor speed. This test&#xD;
      measures choice reaction time. The participants are instructed to respond by pressing the&#xD;
      keys 1-4 of the keyboard, corresponding to the numbers, appearing on the screen of computer&#xD;
      (PDA, SmartPhone). The average of the response latency, measured during the 10 trials is&#xD;
      usually taken as 4CRT outcome.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">March 2016</start_date>
  <completion_date type="Actual">June 25, 2019</completion_date>
  <primary_completion_date type="Actual">June 25, 2019</primary_completion_date>
  <phase>Phase 2</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>Diagnostic</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change of four choice reaction time from baseline</measure>
    <time_frame>One time before the surgery and 2 hours after the surgery</time_frame>
    <description>One time immediately before the surgery and 6 times within 2 hours after the surgery for each participant</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Concentration of midazolam in serum</measure>
    <time_frame>Within 2 hours after the surgery only in 40 (20 from each group) participants</time_frame>
  </secondary_outcome>
  <other_outcome>
    <measure>Postanesthesia discharge scoring system</measure>
    <time_frame>Within 2 hours after the surgery</time_frame>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">124</enrollment>
  <condition>Delayed Recovery From Anaesthesia</condition>
  <arm_group>
    <arm_group_label>Standard therapy group</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Participant who will not receive midazolam for pharmacological anxiolytic premedication before general surgery</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Midazolam group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participant who will receive midazolam for pharmacological anxiolytic premedication before general surgery</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Midazolam</intervention_name>
    <description>The participants receive the pharmacological premedication before the surgery anyway</description>
    <arm_group_label>Midazolam group</arm_group_label>
    <other_name>Dormicum</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Physical status I-III according to American Society of Anesthesiology&#xD;
&#xD;
          -  ambulatory gynecologic surgery of 10-40 min&#xD;
&#xD;
          -  patient is able to use VAS and to use SmartPhone-based 4CRT&#xD;
&#xD;
          -  given informed consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  age &lt; 18 or &gt; 50 years&#xD;
&#xD;
          -  patients who are not able to give their informed consent&#xD;
&#xD;
          -  surgery lasts more than 40 min.&#xD;
&#xD;
          -  history of psychopharmaceuticals or analgesics&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>19 Years</minimum_age>
    <maximum_age>50 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Taras I Usichenko, MD, PhD</last_name>
    <role>Study Director</role>
    <affiliation>University Medicine of Greifswald</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Department of Anesthesiology, Intensive Care Medicine, Emergency Medicine and Pain Therapy</name>
      <address>
        <city>Dresden</city>
        <state>Saxony</state>
        <zip>01067</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Germany</country>
  </location_countries>
  <reference>
    <citation>Zuurmond WW, Balk VA, van Dis H, van Leeuwen L, Paul EA. Multidimensionality of psychological recovery from anaesthesia. Analysing six recovery tests. Anaesthesia. 1989 Nov;44(11):889-92. doi: 10.1111/j.1365-2044.1989.tb09141.x.</citation>
    <PMID>2596654</PMID>
  </reference>
  <verification_date>January 2021</verification_date>
  <study_first_submitted>August 28, 2014</study_first_submitted>
  <study_first_submitted_qc>September 4, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 5, 2014</study_first_posted>
  <last_update_submitted>January 8, 2021</last_update_submitted>
  <last_update_submitted_qc>January 8, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">January 11, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Delayed Emergence from Anesthesia</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>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/NCT02232139
org study id: BR-87/13-1
secondary id: EK-BR-87/13-1
nct id: NCT02232139
lead sponsor: 
collaborator: 
has dmc: No
The aim of the investigation is to validate the SmartPhone-based 4-Reaction Choice Time Test
      (4CRT) as a measure for recovery of the psychomotor function in patients after general
      anesthesia. One hundred female patients, scheduled to ambulatory gynecological surgery in
      general anesthesia, will be randomized to the group with pharmacological anxiolytic
      premedication with midazolam (N=50) and to the group without midazolam (N=50). All patients
      will be monitored using 4CRT before and after standardized general anesthesia. The reaction
      time, measured with 4CRT is the primary outcome parameter of the investigation.
4CRT is a classical psychological test, used to measure the psychomotor speed. This test
      measures choice reaction time. The participants are instructed to respond by pressing the
      keys 1-4 of the keyboard, corresponding to the numbers, appearing on the screen of computer
      (PDA, SmartPhone). The average of the response latency, measured during the 10 trials is
      usually taken as 4CRT outcome.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Diagnostic
masking: None (Open Label)
measure: Change of four choice reaction time from baseline
time frame: One time before the surgery and 2 hours after the surgery
description: One time immediately before the surgery and 6 times within 2 hours after the surgery for each participant
measure: Concentration of midazolam in serum
time frame: Within 2 hours after the surgery only in 40 (20 from each group) participants
measure: Postanesthesia discharge scoring system
time frame: Within 2 hours after the surgery
arm group label: Standard therapy group
arm group type: No Intervention
description: Participant who will not receive midazolam for pharmacological anxiolytic premedication before general surgery
arm group label: Midazolam group
arm group type: Experimental
description: Participant who will receive midazolam for pharmacological anxiolytic premedication before general surgery
intervention type: Drug
intervention name: Midazolam
description: The participants receive the pharmacological premedication before the surgery anyway
arm group label: Midazolam group
other name: Dormicum
criteria: 
gender: Female
minimum age: 19 Years
maximum age: 50 Years
healthy volunteers: No
last name: Taras I Usichenko, MD, PhD
role: Study Director
affiliation: University Medicine of Greifswald
facility: 
country: Germany
citation: Zuurmond WW, Balk VA, van Dis H, van Leeuwen L, Paul EA. Multidimensionality of psychological recovery from anaesthesia. Analysing six recovery tests. Anaesthesia. 1989 Nov;44(11):889-92. doi: 10.1111/j.1365-2044.1989.tb09141.x.
PMID: 2596654
responsible party type: Sponsor
mesh term: Delayed Emergence from Anesthesia
mesh term: Midazolam
sharing ipd: Undecided