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
About this trial
This is an interventional diagnostic trial for Femur Fracture
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
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
NCT ID
NCT04975386
First Posted
July 14, 2021
Last Updated
July 23, 2021
Sponsor
Bursa Yüksek İhtisas Education and Research Hospital
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