Femur FractureNCT04975386
Echocardiography Examination Of The Cardiac Effects Of Different Regional Anesthesia Methods
A study testing Transthoracic echocardiogram in people with Femur Fracture and Spinal Anesthesia, run by Bursa Yuksek Ihtisas Training and Research Hospital.
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. Read more about this study
- Who is it for?
- Ages 60 to 100 years
- Conditions the study is for
- Femur Fracture, Spinal Anesthesia, Lumbar Plexus Block
- What is being tested?
- Transthoracic echocardiogram
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 62 participants
- Where
- No sites listed yet
- Study dates
- 29 Jul 2021to 15 Aug 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 60-100 years old
- American Society of Anesthesiologist Score I-IV
Who cannot join
- Local anesthetic allergy
- Bleeding disorder
- Mental disorder
- Allergy to drugs used
- Body mass index above 30
Trial locations and contacts
No sites are listed yet.
About this study
Official title: 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.
Read the 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.
- Conditions
- Femur Fracture, Spinal Anesthesia, Lumbar Plexus Block
- Being tested
- Transthoracic echocardiogram
- Medical subject headings
- Femoral Fractures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transthoracic echocardiogramDevice
Transthoracic echocardiogram will be performed before the operation and at certain time intervals during the operation.
| Study group | Role | What they receive |
|---|---|---|
| spinal anesthesia | Active comparator | Not described Receives: Device: Transthoracic echocardiogram |
| lumbar plexus+sacral plexus block | Active comparator | Not described Receives: Device: Transthoracic echocardiogram |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ejection fraction
Ejection fraction (EF) measurement will be made with Simpson's method and fractional shortening method.
Measured: peroperative
Secondary outcomes (5)
intraoperative blood pressure monitoring
systolic, diastolic and median blood pressure values
Measured: 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.
Measured: peroperative
Entropy
Depth of anesthesia will be measured by placing Entropy sensors on the forehead as needed.
Measured: peroperative
sedative drug
The drugs used for sedation and their amounts will be recorded.
Measured: 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.
Measured: intraoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jul 2021
- Study start29 Jul 2021 (estimated)
- Primary completion29 Jul 2022 (estimated)
- Study completion15 Aug 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Femur FractureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 62 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Bursa Yuksek Ihtisas Training and Research Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Korgün Ökmen, Bursa Yuksek Ihtisas Training and Research Hospital
- Investigators
- Durdu M.D Kahraman Yıldız, Principal investigator, Bursa Yuksek Ihtisas Training and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04975386
- Sponsor's protocol ID
- 2011-KAEK-25 2020/10-03
- Status last verified
- Jul 2021
- First submitted
- 14 Jul 2021
- Last updated
- 29 Jul 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Echocardiographic Investigation of the Cardiac Effects of Different Regional Anesthesia Methods Used in Intertrochanteric Femoral Fracture Operations
- ClinicalTrials.gov ID
- NCT04975386
- Acronym / sponsor ID
- 2011-KAEK-25 2020/10-03
- Conditions
- Femur Fracture, Spinal Anesthesia, Lumbar Plexus Block
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 62 participants (estimated)
- Lead sponsor
- Bursa Yuksek Ihtisas Training and Research HospitalOther government
- Study start
- 29 Jul 2021 (estimated)
- Primary completion
- 29 Jul 2022 (estimated)
- Study completion
- 15 Aug 2022 (estimated)
- First posted
- 23 Jul 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| spinal anesthesia | Active comparator | Device: Transthoracic echocardiogram |
| lumbar plexus+sacral plexus block | Active comparator | Device: Transthoracic echocardiogram |
Who may qualify
- Ages
- 60 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 60-100 years old
- American Society of Anesthesiologist Score I-IV
Key exclusion criteria (5 listed)
- Local anesthetic allergy
- Bleeding disorder
- Mental disorder
- Allergy to drugs used
- Body mass index above 30
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Transthoracic echocardiogramTransthoracic echocardiogram will be performed before the operation and at certain time intervals during the operation. | Device | lumbar plexus+sacral plexus block, spinal anesthesia |
Primary outcome
Ejection fraction
Time frame: peroperative
Ejection fraction (EF) measurement will be made with Simpson's method and fractional shortening method.
5 secondary outcomes
intraoperative blood pressure monitoring
Time frame: peroperative
cardiac diastolic dysfunction
Time frame: peroperative
Entropy
Time frame: peroperative
sedative drug
Time frame: intraoperative
ramsey sedation scale
Time frame: intraoperative
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jul 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Durdu M.D Kahraman Yıldız principal investigator
Bursa Yuksek Ihtisas Training and Research Hospital
Questions about this trial
What is this clinical trial studying?
A study testing Transthoracic echocardiogram in people with Femur Fracture and Spinal Anesthesia, run by Bursa Yuksek Ihtisas Training and Research Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 29 Jul 2021. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Korgün Ökmen, Assoc. PhD. (+905057081021, korgunokmen@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Ejection fraction (time frame: peroperative). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jul 2021.