Echocardiography Examination Of The Cardiac Effects Of Different Regional Anesthesia Methods

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Spinal Anesthesia; Femur Fracture; Lumbar Plexus Block
• Intervention / Treatment: Device: Transthoracic echocardiogram

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.

• Study Type: Interventional
• Enrollment (Anticipated): 62
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Korgün M.D Ökmen, Assoc. PhD.; Phone Number: +905057081021; Email: korgunokmen@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 60 years to 100 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: DIAGNOSTIC
• Allocation: NON_RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: spinal anesthesia	Device: Transthoracic echocardiogram; Transthoracic echocardiogram will be performed before the operation and at certain time intervals during the operation.
ACTIVE_COMPARATOR: lumbar plexus+sacral plexus block	Device: Transthoracic echocardiogram; Transthoracic echocardiogram will be performed before the operation and at certain time intervals during the operation.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Ejection fraction	Ejection fraction (EF) measurement will be made with Simpson's method and fractional shortening method.	peroperative

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
intraoperative blood pressure monitoring	systolic, diastolic and median blood pressure values	peroperative
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
Entropy	Depth of anesthesia will be measured by placing Entropy sensors on the forehead as needed.	peroperative
sedative drug	The drugs used for sedation and their amounts will be recorded.	intraoperative
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

Collaborators and Investigators

• Sponsor: Bursa Yüksek İhtisas Education and Research Hospital
• Investigators: Principal Investigator: Durdu M.D Kahraman Yıldız, University of Health Sciences, Bursa Yuksek Ihtisas Training and Research Hospital

Study record dates

Study Major Dates

• Study Start (ANTICIPATED): July 29, 2021
• Primary Completion (ANTICIPATED): July 29, 2022
• Study Completion (ANTICIPATED): August 15, 2022

Study Registration Dates

• First Submitted: July 14, 2021
• First Submitted That Met QC Criteria: July 22, 2021
• First Posted (ACTUAL): July 23, 2021

Study Record Updates

• Last Update Posted (ACTUAL): July 29, 2021
• Last Update Submitted That Met QC Criteria: July 23, 2021
• Last Verified: July 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Fractures, Bone; Wounds and Injuries; Leg Injuries; Femoral Fractures
• Other Study ID Numbers: 2011-KAEK-25 2020/10-03

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No