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Assessment of Phase Lag Entropy(PLE) monitor for the sedation levels using propofol in upper limb surgery patients under brachial plexus block

Status Approved

  • First Submitted Date

    2017/09/14

  • Registered Date

    2017/11/17

  • Last Updated Date

    2018/01/17

CRIS Required

WHO ICTRP (International Clinical Trial Registry Platform) Required

  • 1. Background

    Background - CRIS Registration Number, Unique Protocol ID, Public/Brief Title, Scientific Title, Acronym, MFDS Regulated Study, IND/IDE Protocol, Registered at Other Registry, Name of Registry/Registration Number
    CRIS
    Registration Number
    KCT0002542
    Unique Protocol ID SCHUH 2017-05-018-001
    Public/Brief Title Assessment of Phase Lag Entropy(PLE) monitor for the sedation levels using propofol
    Scientific Title Assessment of Phase Lag Entropy(PLE) monitor for the sedation levels using propofol in upper limb surgery patients under brachial plexus block
    Acronym PLE
    MFDS Regulated Study No
    IND/IDE Protocol No
    Registered at Other Registry No
    Healthcare Benefit Approval Status
  • 2. Institutional Review Board / Ethics Committee

    Institutional Review Board Information
    Board Approval Status Submitted approval
    Board Approval Number SCHUH 2017-05-018-001
    Approval Date 2017-07-06
    Institutional Review Board Name Institutional Review Board of Soonchunhyang Universty Seoul Hospital
    Institutional Review Board Address
    Institutional Review Board Telephone
    Data Monitoring Committee No
  • 3. Contact Details

    Contact Details Information - Contact Person for Principal Investigator / Scientific Queries, Contact Person for Public Queries, Contact Person for Updating Information의 Name, Title, Email, Telephone, Cellular Phone, Affiliation, Address
    Contact Person for Principal Investigator / Scientific Queries
    Name Soon Im Kim
    Title professor
    Telephone +82-2-709-9294
    Affiliation Soon Chun Hyang University
    Address 22 Soonchunhyang-Ro, Asan city, Chungchungnamdo, Korea
    Contact Person for Public Queries
    Name Soon Im Kim
    Title professor
    Telephone +82-2-709-9294
    Affiliation Soon Chun Hyang University
    Address 22 Soonchunhyang-Ro, Asan city, Chungchungnamdo, Korea
    Contact Person for Updating Information
    Name Soon Im Kim
    Title professor
    Telephone +82-2-709-9294
    Affiliation Soon Chun Hyang University
    Address 22 Soonchunhyang-Ro, Asan city, Chungchungnamdo, Korea
  • 4. Status

    Status Information - Study Site, Overall Recruitment Status, Date of First Enrollment, Status of First Enrollment, Target Number of Participant, Primary Completion Date, Recruitment Status by Participating Study Site, Name of Study Site, Recruitment Status, Date of First Enrollment, Status of First Enrollemnt
    Study Site Single
    Overall Recruitment Status Recruiting
    Date of First Enrollment 2017-07-12 Actual
    Target Number of Participant 30
    Primary Completion Date
    Study Completion Date
    Recruitment Status by Participating Study Site 1
    Name of Study Soon Chun Hyang University Hospital Seoul
    Recruitment Status Recruiting
    Date of First Enrollment 2017-07-12 ,
  • 5. Source of Monetary / Material Support

    Source of Monetary / Material Support Information - Organization Name, Organization Type, Project ID
    1. Source of Monetary/Material Support
    Organization Name InBody
    Organization Type Others
    Project ID
  • 6. Sponsor Organization

    Sponsor Organization Information - Organization Name, Organization Type
    1. Sponsor Organization
    Organization Name Soon Chun Hyang University Hospital Seoul
    Organization Type Medical Institute
  • 7. Study Summary

    Study Summary Information
    Lay Summary
    The aim of this study is to assess the  Phase Lag Entropy(PLE) monitor for the sedation levels using propofol in upper limb surgery patients under brachial plexus block.
    
    
  • 8. Study Design

    Study Design Information - Study Type, Observational Study Model, Time Perspective, Target Number of Participant, Cohort/Group Number, Cohort/Group, Cohort/Group Label, Cohort/Group Description, Biospecimen Collection & Archiving, Biospecimen Description
    Study Type Observational Study
    Observational Study Model Case-only
    Time Perspective Prospective  
    Target Number of Participant 30
    Cohort/Group Number 1
    Cohort/
    Group 1

    Cohort/Group Label

     PLE group

    Cohort/Group Description

    we assess the corrrelation of  OAA/S Scale  and PLE index, and comparison PLE with BIS to assess the sedation level.
    Biospecimen
    Collection & Archiving
    Not collect nor Archive
    Biospecimen Description
  • 9. Subject Eligibility

    Subject Eligibility Information
    Study Population Description
    adult patients ( >18 yr old) who undergoing upper arm surgery under brachial plexus block using ultrasonogram
    Healthy patient who is American Society of Anesthesiology (ASA) physical status 1or 2. 
    Sampling Method
    purposive sapling
    Condition(s)/Problem(s)    Not Applicable-Anesthesia 
    Rare Disease No
    Inclusion Criteria

    Gender

    Both

    Age

    19Year~No Limit

    Description

    adult patients ( >18 yr old) who undergoing upper arm surgery under brachial plexus block using ultrasonogram
    Healthy patient who is American Society of Anesthesiology (ASA)  physical status 1or 2. 
    Exclusion Criteria
    -patient who has CNS disease, past history of CNS disease, and neurological disorder
    - patient who has been taken  anticonvulsant agent, sedatives, analgesics, and hypnotics .
    - significant hepatic disease or renal disease
    - obesity (BMI>30)
    _ Obstructive sleep apnea 
    - hypersensitivity to propofol or local anesthetics
    -  hypersensitivity to bean or peanut
    _ pregnant woman
    Healthy Volunteers No
  • 10. Outcome Measure(s)

    Outcome Measure(s) Information - Type of Primary Outcome, Primary Outcome, Outcome, Timepoint, Secondary Outcome, Outcome, Timepoint
    Type of Primary Outcome Efficacy
    Primary Outcome(s) 1
    Outcome
    correlation of  OAA/S Scale and  PLE
    Timepoint
    propofol로 진정시킬 때
    Secondary Outcome(s) 1
    Outcome
    comparison PLE with BIS  
    Timepoint
    propofol로 진정시킬 때
  • 11. Study Results and Publication

    Study Results and Publication Information - Result Registered, Final Enrollment Number, Number of Publication, Publications, Results Upload, Date of Posting Results, Protocol URL or File Upload, Brief Summary
    Result Registered
  • 12. Sharing of Study Data(Deidentified Individual-Patient Data, IPD)

    Sharing of Study Data Information - Sharing Statement, Time of Sharing, Way of Sharing
    Sharing Statement Not provided at time of Registration
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