Echocardiography Examination Of The Cardiac Effects Of Different Regional Anesthesia Methods

Spinal Anesthesia Clinical Trial

Official title:

Echocardiographic Investigation of the Cardiac Effects of Different Regional Anesthesia Methods Used in Intertrochanteric Femoral Fracture Operations

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04975386
• Other study ID #: 2011-KAEK-25 2020/10-03
• Status: Not yet recruiting
• Phase: N/A
• Start date: July 29, 2021
• Est. completion date: August 15, 2022

Study information

• Verified date: July 2021
• Source: Bursa Yüksek Ihtisas Education and Research Hospital
• Contact: Korgün Ökmen, Assoc. PhD.
• Phone: +905057081021
• Email: korgunokmen[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 62
• Est. completion date: August 15, 2022
• Est. primary completion date: July 29, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 60 Years to 100 Years

Eligibility

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

Related Conditions & MeSH terms

• Femoral Fractures
• Femur Fracture
• Fractures, Bone
• Lumbar Plexus Block
• Spinal Anesthesia

Intervention

Device:
• Transthoracic echocardiogram
Transthoracic echocardiogram will be performed before the operation and at certain time intervals during the operation.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Bursa Yüksek Ihtisas Education and Research Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Ejection fraction	Ejection fraction (EF) measurement will be made with Simpson's method and fractional shortening method.	peroperative
Secondary	intraoperative blood pressure monitoring	systolic, diastolic and median blood pressure values	peroperative
Secondary	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.	peroperative
Secondary	Entropy	Depth of anesthesia will be measured by placing Entropy sensors on the forehead as needed.	peroperative
Secondary	sedative drug	The drugs used for sedation and their amounts will be recorded.	intraoperative
Secondary	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.	intraoperative