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Effect of central obesity on the level of blockade during spinal anesthesia

Status Approved

  • First Submitted Date

    2015/10/13

  • Registered Date

    2015/10/16

  • Last Updated Date

    2016/07/26

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
    KCT0001664
    Unique Protocol ID 20150918/16-2015-136/101
    Public/Brief Title Effect of central obesity on the level of blockade during spinal anesthesia
    Scientific Title Effect of central obesity on the level of blockade during spinal anesthesia
    Acronym
    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 20150918/16-2015-136/101
    Approval Date 2015-10-12
    Institutional Review Board Name Ethics commttee of Seoul Metropolitan Goverment Seoul National University Boramae Medical Center
    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 Jin-Young Hwang
    Title M.D. Ph.D.
    Telephone +82-2-870-2518
    Affiliation Seoul Metropolitan Government Seoul National University Boramae Medical Center
    Address 425 Shindaebangdong Dongjakgu Seoul
    Contact Person for Public Queries
    Name Jin-Young Hwang
    Title M.D. Ph.D.
    Telephone +82-2-870-2518
    Affiliation Seoul Metropolitan Government Seoul National University Boramae Medical Center
    Address 425 Shindaebangdong Dongjakgu Seoul
    Contact Person for Updating Information
    Name Jin-Young Hwang
    Title M.D. Ph.D.
    Telephone +82-2-870-2518
    Affiliation Seoul Metropolitan Government Seoul National University Boramae Medical Center
    Address 425 Shindaebangdong Dongjakgu Seoul
  • 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 Completed
    Date of First Enrollment 2015-11-10 Actual
    Target Number of Participant 58
    Primary Completion Date 2016-07-15 , Actual
    Study Completion Date 2016-07-15 , Actual
    Recruitment Status by Participating Study Site 1
    Name of Study Seoul Metropolitan Government Seoul National University Boramae Medical Center
    Recruitment Status Completed
    Date of First Enrollment 2015-11-10 ,
  • 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 Seoul Metropolitan Government Seoul National University Boramae Medical Center
    Organization Type Medical Institute
    Project ID 20150918/16-2015-136
  • 6. Sponsor Organization

    Sponsor Organization Information - Organization Name, Organization Type
    1. Sponsor Organization
    Organization Name Seoul Metropolitan Government Seoul National University Boramae Medical Center
    Organization Type Medical Institute
  • 7. Study Summary

    Study Summary Information
    Lay Summary
    The aim of this study is to evaluate the effect of waist circumference (presence of central obesity) on the sensory and motor blockade, time to achieve maximal level of bockade, and the duration of spinal blockde during spinal anesthesia.
  • 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 Cross-sectional  
    Target Number of Participant 58
    Cohort/Group Number 2
    Cohort/
    Group 1

    Cohort/Group Label

    Waist circumference <85 cm

    Cohort/Group Description

    After the induction of spinal anesthesia, sensory and motor blockade, time to maximal blockade, duration of blockade are recorded. 
    Cohort/
    Group 2

    Cohort/Group Label

    Waist circumference ≥85 cm

    Cohort/Group Description

    After the induction of spinal anesthesia, sensory and motor blockade, time to maximal blockade, duration of blockade are recorded. 
    Biospecimen
    Collection & Archiving
    Not collect nor Archive
    Biospecimen Description
  • 9. Subject Eligibility

    Subject Eligibility Information
    Study Population Description
    Female patients older than 60 yrs of age undergoing sinal anestheisa  
    Sampling Method
    Patients scheduled for elective surgery under spinal anesthesia are screened. 
    Condition(s)/Problem(s) * (E00-E90)Endocrine, nutritional and metabolic diseases 
       (E66.9)Obesity, unspecified 
    Rare Disease No
    Inclusion Criteria

    Gender

    Female

    Age

    61Year~No Limit

    Description

    Female patients older than 60 yrs of age undergoing sinal anestheisa 
    Exclusion Criteria
    BMI < 23 or > 27.5 kg/m2
    Height < 150 cm or >170 cm  
    Spinal deformity (ex. ankylosing spondylitis)
    
    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 /Safety/Efficacy
    Primary Outcome(s) 1
    Outcome
    Maximal sensory blockade level
    Timepoint
    After the induction of spinal anesthesia
    Secondary Outcome(s) 1
    Outcome
    Duration of sensory and motor blockade
    Timepoint
    From the inductin of spinal anestheia to the time for sensory blockade level L2, motor score 0
    Secondary Outcome(s) 2
    Outcome
    Occurrence of hypotension
    Timepoint
    Durig spnal anesthesia
    Secondary Outcome(s) 3
    Outcome
    Ephedrine requirement
    Timepoint
    Duing spinal anesthesia
    Secondary Outcome(s) 4
    Outcome
    Occurrence of bradycardia
    Timepoint
    During spinal anesthesia
    Secondary Outcome(s) 5
    Outcome
    Incience of nausea and vomiting
    Timepoint
    During spinal anesthesia
    Secondary Outcome(s) 6
    Outcome
    Mean arterial pressure, Heart rate
    Timepoint
    After the induction of spinal anesthesia, every 1 min for 20 min, and then every 5 min for 40 min
    Secondary Outcome(s) 7
    Outcome
    Maximum motor blockade level
    Timepoint
    After the induction of spinal anesthesia 
    Secondary Outcome(s) 8
    Outcome
    Time to achieve maximal sensory blockade
    Timepoint
    After the induction of spinal anesthesia
    Secondary Outcome(s) 9
    Outcome
    Time to achieve maximal motor blockade
    Timepoint
    After the induction of spinal anesthesia
  • 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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