search
Back to results

Echocardiography Examination Of The Cardiac Effects Of Different Regional Anesthesia Methods

Primary Purpose

Femur Fracture, Spinal Anesthesia, Lumbar Plexus Block

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Transthoracic echocardiogram
Sponsored by
Bursa Yüksek İhtisas Education and Research Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Femur Fracture

Eligibility Criteria

60 Years - 100 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 60-100 years old
  • American Society of Anesthesiologist Score I-IV

Exclusion Criteria:

  • Local anesthetic allergy
  • Bleeding disorder
  • Mental disorder
  • Allergy to drugs used
  • Body mass index above 30

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Active Comparator

    Arm Label

    spinal anesthesia

    lumbar plexus+sacral plexus block

    Arm Description

    Outcomes

    Primary Outcome Measures

    Ejection fraction
    Ejection fraction (EF) measurement will be made with Simpson's method and fractional shortening method.

    Secondary Outcome Measures

    intraoperative blood pressure monitoring
    systolic, diastolic and median blood pressure values
    cardiac diastolic dysfunction
    The echocardiogram will measure the flow velocity between the left atrium and ventricle in cm/s in pulsed wave mode and the E/A ratio will be calculated.
    Entropy
    Depth of anesthesia will be measured by placing Entropy sensors on the forehead as needed.
    sedative drug
    The drugs used for sedation and their amounts will be recorded.
    ramsey sedation scale
    point Awake, restless and/or crying. points Alert, calm, watching his surroundings. points Sleepy but responds to verbal stimuli points Sleepy but immediately responds to glabellar tactile stimuli. points Sleepy but responds slowly to glabellar tactile stimuli. points Does not respond to Alerts.

    Full Information

    First Posted
    July 14, 2021
    Last Updated
    July 23, 2021
    Sponsor
    Bursa Yüksek İhtisas Education and Research Hospital
    search

    1. Study Identification

    Unique Protocol Identification Number
    NCT04975386
    Brief Title
    Echocardiography Examination Of The Cardiac Effects Of Different Regional Anesthesia Methods
    Official Title
    Echocardiographic Investigation of the Cardiac Effects of Different Regional Anesthesia Methods Used in Intertrochanteric Femoral Fracture Operations
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    July 2021
    Overall Recruitment Status
    Unknown status
    Study Start Date
    July 29, 2021 (Anticipated)
    Primary Completion Date
    July 29, 2022 (Anticipated)
    Study Completion Date
    August 15, 2022 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Bursa Yüksek İhtisas Education and Research Hospital

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    Nerve blocks applied with neuraxial anesthesia and ultrasonography are used for many operations today. Neuraxial blocks cause varying degrees of decrease in the blood pressure level of the patients. Peripheral blocks may be preferred to avoid the cardiac effects of the neuraxial anesthesia method.
    Detailed Description
    The hypothesis of this study was that spinal anesthesia applied in intertrochanteric femoral fracture operations caused hypotension by lowering the cardiac ejection fraction. In our study, The investigators aimed to find out the effect of different regional anesthesia methods on the cardiac function of the patients by echocardiography.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Femur Fracture, Spinal Anesthesia, Lumbar Plexus Block

    7. Study Design

    Primary Purpose
    Diagnostic
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Non-Randomized
    Enrollment
    62 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    spinal anesthesia
    Arm Type
    Active Comparator
    Arm Title
    lumbar plexus+sacral plexus block
    Arm Type
    Active Comparator
    Intervention Type
    Device
    Intervention Name(s)
    Transthoracic echocardiogram
    Intervention Description
    Transthoracic echocardiogram will be performed before the operation and at certain time intervals during the operation.
    Primary Outcome Measure Information:
    Title
    Ejection fraction
    Description
    Ejection fraction (EF) measurement will be made with Simpson's method and fractional shortening method.
    Time Frame
    peroperative
    Secondary Outcome Measure Information:
    Title
    intraoperative blood pressure monitoring
    Description
    systolic, diastolic and median blood pressure values
    Time Frame
    peroperative
    Title
    cardiac diastolic dysfunction
    Description
    The echocardiogram will measure the flow velocity between the left atrium and ventricle in cm/s in pulsed wave mode and the E/A ratio will be calculated.
    Time Frame
    peroperative
    Title
    Entropy
    Description
    Depth of anesthesia will be measured by placing Entropy sensors on the forehead as needed.
    Time Frame
    peroperative
    Title
    sedative drug
    Description
    The drugs used for sedation and their amounts will be recorded.
    Time Frame
    intraoperative
    Title
    ramsey sedation scale
    Description
    point Awake, restless and/or crying. points Alert, calm, watching his surroundings. points Sleepy but responds to verbal stimuli points Sleepy but immediately responds to glabellar tactile stimuli. points Sleepy but responds slowly to glabellar tactile stimuli. points Does not respond to Alerts.
    Time Frame
    intraoperative

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    60 Years
    Maximum Age & Unit of Time
    100 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: 60-100 years old American Society of Anesthesiologist Score I-IV Exclusion Criteria: Local anesthetic allergy Bleeding disorder Mental disorder Allergy to drugs used Body mass index above 30
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Korgün Ökmen, Assoc. PhD.
    Phone
    +905057081021
    Email
    korgunokmen@gmail.com
    First Name & Middle Initial & Last Name or Official Title & Degree
    Korgün M.D Ökmen, Assoc. PhD.
    Phone
    +905057081021
    Email
    korgunokmen@gmail.com
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Durdu M.D Kahraman Yıldız
    Organizational Affiliation
    University of Health Sciences, Bursa Yuksek Ihtisas Training and Research Hospital
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

    Echocardiography Examination Of The Cardiac Effects Of Different Regional Anesthesia Methods

    We'll reach out to this number within 24 hrs