Hip FracturesNCT03596060
Regional vs General Anesthesia in Patients With Hip Fracture Under Treatment With Clopidogrel
A study testing Fentanyl, Propofol and Rocuronium in people with Hip Fractures, run by Larissa University Hospital at 1 site in Greece.
Trial summary
This study compares general to regional anesthesia concerning morbidity and mortality in patients older than or equal to 65 years old who receive clopidogrel and are to be submitted in hip fracture surgery. Read more about this study
- Who is it for?
- Ages 65 to 100 years
- Conditions the study is for
- Hip Fractures
- What is being tested?
- Fentanyl, Propofol and Rocuronium
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteGreece
- Study dates
- 20 Oct 2017to Oct 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 65 to 100 years
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- Patients older than or equal to 65 years old with hip fracture
- Native language greek and capable of speaking and writing
- Primary school graduated
- Is about to undergo in orthopedic surgery
- Participants should be available until the end of the prefixed end date of the research
Who cannot join
- Severe hearing impairment and visual acuity
- Major cognitive impairment (Mini Mental State Examination <24)
- Medical history of central nervous system disease including stroke with neurological deficit
- Medical history of alcohol or drug abuse
- Dementia, Parkinson disease, Alzheimer disease
- Contraindication for general or regional anesthesia
Show all 10Show fewer
- Severe contraindication for antiplatelet agent discontinuation
- Multiple failures
- Receiving other coagulants
- No written consent
Trial locations and contacts
1 site in 1 country.
Greece1 site, 1 recruiting
- Recruiting
Larissa University Hospital
Larissa, 41335
Aikaterini Tsiaka, MD, MSc, 00306977298282, ktsiaka@yahoo.gr
About this study
This study compares general to regional anesthesia concerning morbidity and mortality in patients older than or equal to 65 years old who receive clopidogrel and are to be submitted in hip fracture surgery. Half of participants will receive general anesthesia the first 48 hours and the other half will receive regional anesthesia after 5 days of the discontinuation of clopidogrel.
- Conditions
- Hip Fractures
- Keywords
- hip fracture, general anesthesia, regional anesthesia, clopidogrel, cognitive impairment, mortality
- Medical subject headings
- Hip Fractures, Cognitive Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FentanylDrug
Fentanyl will be used for introduction in both regional and general anesthesia. It will also be used for general anesthesia maintenance.
PropofolDrug
Propofol will be used for introduction in general anesthesia.
RocuroniumDrug
Rocuronium will be used for introduction in general anesthesia.
ChirochaineDrug
Chirochaine 0.5% will be used in regional anesthesia.
MorphineDrug
Morphine will be administered bolus iv in General anesthesia group postoperatively before patients leave OR.
| Study group | Role | What they receive |
|---|---|---|
| General anesthesia | Active comparator | Hip fracture patients older or equal to 65 years of age, who receive clopidogrel, will be randomly assigned to undertake surgery under general anesthesia in the first 48 hours. Anesthetics to be used are propofol, fentanyl and rocuronium. Maintenance will be achieved with remifentanyl and propofol (TIVA) and the depth of anesthesia will be monitored by BIS. Morphine will be administered bolus IV immediately postoperatively. Receives: Drug: Fentanyl; Drug: Propofol; Drug: Rocuronium; Drug: Morphine |
| Regional anesthesia | Active comparator | Hip fracture patients older or equal to 65 years of age, who receive clopidogrel, will will be randomly assigned undertake surgery under regional anesthesia (spinal) at least 5 days after the discontinuation of clopidogrel. Anesthetics to be used are chirochaine 0.5% and fentanyl. Receives: Drug: Fentanyl; Drug: Chirochaine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mortality
To compare postoperative 30-day mortality between General anesthesia and Regional anesthesia group
Measured: 30 days
Secondary outcomes (12)
Major Cardiovascular Events
To check and compare between General anesthesia and Regional anesthesia group for major cardiovascular events (arrhythmias, stroke, cardiac arrest, acute myocardial infract, acute respiratory oedema, pulmonary embolism) postoperatively in 30 days and 3, 6, 12 months.
Measured: Events will be recorded for both groups from date of surgery postop up to 12 months or date of death from any cause, with intermediate recordings in 1, 3 and 6 months periods in survivors
Change in cognitive status
To measure and compare, between General anesthesia and Regional anesthesia group, Cognitive status using Mini Mental State Examination and Clock Test before surgery and 6, 12 months postoperatively
Measured: Cognitive function will be measured for both groups on admission (preop), 6 months and 12 months postop
Delirium
Occurrence of delirium and comparison between General anesthesia and Regional anesthesia group with the use of Confusion Assessment Method before surgery and in 2, 3, 4 and 7 days postoperatively.
Measured: Occurrence of delirium will be measured, for both groups, on admission (preop) and days 2, 3, 4 and 7 postop (two tests per day, morning and evening hours)
Adverse events postoperatively
Occurrence of adverse events in both General anesthesia and Regional anesthesia groups, especially respiratory, renal, surgical trauma in 30 days postoperatively.
Measured: 30 days
Re-admissions
Re admissions in both General anesthesia and Regional anesthesia groups in 30 days postoperatively.
Measured: 30 days
Postoperative analgesic use
Use of analgesics (pethidine, paracetamol), counted in milligrams as a mean per day, from the time patients are transfered to the orthopedic ward until 30 days postop in both General anesthesia and Regional anesthesia groups targeting Numerical Rating Scale score <4 (range is from 0 to 10 and a higher score indicates greater pain intensity).
Measured: 30 days
Time of hospitalization
To check and compare in both General anesthesia and Regional anesthesia groups time to hospital discharge.
Measured: Time to discharge will be considered the time duration from date of surgery until the date of discharge or date of death from any cause while hospitalised, whichever came first, assessed up to 1 month
Adverse events intraoperatively
To check and compare in both General anesthesia and Regional anesthesia groups incidence of low blood pressure (< 20% from baseline), bradycardia (<50 bpm), hemorrhage and need of blood transfusions, use of antifibrinolytics intraoperatively
Measured: During operation time frame
Functionality in daily living
To check and compare between both General anesthesia and Regional anesthesia groups 6 months postoperatively functionality using Instrumental Activities of Daily Living scale
Measured: 6 months
Timed Up and Go Test (TUG)
To determine fall risk and measure the progress of balance, sit to stand, and walking using Timed Up and Go Test (TUG) and compare these attributes between General anesthesia and Regional anesthesia groups 1, 3 and 6 months postoperatively
Measured: Measurements will be assessed 1, 3 and 6 months postop
EQ-5D-5L (EuroQol group, 5 dimensions, 5 levels)
With the use of EQ-5D-5L to check and compare between General anesthesia and Regional anesthesia groups 1, 3 and 6 months postoperatively mobility, self-care, usual activities, pain/discomfort and anxiety/depression.
Measured: Measurements will be assessed at 1, 3 and 6 months postop
Oxford hip score
To assess function and pain in both General anesthesia and Regional anesthesia groups 1, 3 and 6 months postoperatively by using Oxford hip score
Measured: Measurements will be assessed at 1, 3 and 6 months postop
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jul 2018
- Study start20 Oct 2017
- Primary completionMay 2022 (estimated)
- Study completionOct 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hip FracturesStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Larissa University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Aikaterini Tsiaka, MD, Larissa University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03596060
- Sponsor's protocol ID
- 5505/19.10.2017
- Status last verified
- Sep 2021
- First submitted
- 2 Jun 2018
- Last updated
- 28 Sep 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 28 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Regional vs General Anesthesia in Patients With Hip Fracture Under Treatment With Clopidogrel
- ClinicalTrials.gov ID
- NCT03596060
- Acronym / sponsor ID
- 5505/19.10.2017
- Conditions
- Hip Fractures
- Keywords
- hip fracture, general anesthesia, regional anesthesia, clopidogrel, cognitive impairment, mortality
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Larissa University HospitalUniversity, hospital or other
- Study start
- 20 Oct 2017 (actual)
- Primary completion
- May 2022 (estimated)
- Study completion
- Oct 2022 (estimated)
- First posted
- 23 Jul 2018 (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.
This study compares general to regional anesthesia concerning morbidity and mortality in patients older than or equal to 65 years old who receive clopidogrel and are to be submitted in hip fracture surgery. Half of participants will receive general anesthesia the first 48 hours and the other half will receive regional anesthesia after 5 days of the discontinuation of clopidogrel.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| General anesthesia | Active comparator | Drug: Fentanyl, Drug: Propofol, Drug: Rocuronium, Drug: MorphineHip fracture patients older or equal to 65 years of age, who receive clopidogrel, will be randomly assigned to undertake surgery under general anesthesia in the first 48 hours. Anesthetics to be used are propofol, fentanyl and rocuronium. Maintenance will be achieved with remifentanyl and propofol (TIVA) and the depth of anesthesia will be monitored by BIS. Morphine will be administered bolus IV immediately postoperatively. |
| Regional anesthesia | Active comparator | Drug: Fentanyl, Drug: ChirochaineHip fracture patients older or equal to 65 years of age, who receive clopidogrel, will will be randomly assigned undertake surgery under regional anesthesia (spinal) at least 5 days after the discontinuation of clopidogrel. Anesthetics to be used are chirochaine 0.5% and fentanyl. |
Who may qualify
- Ages
- 65 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (5 listed)
- Patients older than or equal to 65 years old with hip fracture
- Native language greek and capable of speaking and writing
- Primary school graduated
- Is about to undergo in orthopedic surgery
- Participants should be available until the end of the prefixed end date of the research
Key exclusion criteria (10 listed)
- Severe hearing impairment and visual acuity
- Major cognitive impairment (Mini Mental State Examination <24)
- Medical history of central nervous system disease including stroke with neurological deficit
- Medical history of alcohol or drug abuse
- Dementia, Parkinson disease, Alzheimer disease
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 |
|---|---|---|
| FentanylFentanyl will be used for introduction in both regional and general anesthesia. It will also be used for general anesthesia maintenance. | Drug | General anesthesia, Regional anesthesia |
| PropofolPropofol will be used for introduction in general anesthesia. | Drug | General anesthesia |
| RocuroniumRocuronium will be used for introduction in general anesthesia. | Drug | General anesthesia |
| ChirochaineChirochaine 0.5% will be used in regional anesthesia. | Drug | Regional anesthesia |
| MorphineMorphine will be administered bolus iv in General anesthesia group postoperatively before patients leave OR. | Drug | General anesthesia |
Primary outcome
Mortality
Time frame: 30 days
To compare postoperative 30-day mortality between General anesthesia and Regional anesthesia group
12 secondary outcomes
Major Cardiovascular Events
Time frame: Events will be recorded for both groups from date of surgery postop up to 12 months or date of death from any cause, with intermediate recordings in 1, 3 and 6 months periods in survivors
Change in cognitive status
Time frame: Cognitive function will be measured for both groups on admission (preop), 6 months and 12 months postop
Delirium
Time frame: Occurrence of delirium will be measured, for both groups, on admission (preop) and days 2, 3, 4 and 7 postop (two tests per day, morning and evening hours)
Adverse events postoperatively
Time frame: 30 days
Re-admissions
Time frame: 30 days
Postoperative analgesic use
Time frame: 30 days
Time of hospitalization
Time frame: Time to discharge will be considered the time duration from date of surgery until the date of discharge or date of death from any cause while hospitalised, whichever came first, assessed up to 1 month
Adverse events intraoperatively
Time frame: During operation time frame
Functionality in daily living
Time frame: 6 months
Timed Up and Go Test (TUG)
Time frame: Measurements will be assessed 1, 3 and 6 months postop
EQ-5D-5L (EuroQol group, 5 dimensions, 5 levels)
Time frame: Measurements will be assessed at 1, 3 and 6 months postop
Oxford hip score
Time frame: Measurements will be assessed at 1, 3 and 6 months postop
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Sep 2021.
- Individual participant dataSharing planned: Undecided
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Fentanyl, Propofol and Rocuronium in people with Hip Fractures, run by Larissa University Hospital at 1 site in Greece.
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 5 inclusion and 10 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 28 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Greece. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mortality (time frame: 30 days). 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 28 Sep 2021.