Hip Fractures
Conditions
Keywords
hip fracture, general anesthesia, regional anesthesia, clopidogrel, cognitive impairment, mortality
Brief 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. 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.
Interventions
DRUGChirochaine
Chirochaine 0.5% will be used in regional anesthesia.
DRUGFentanyl
Fentanyl will be used for introduction in both regional and general anesthesia. It will also be used for general anesthesia maintenance.
DRUGPropofol
Propofol will be used for introduction in general anesthesia.
DRUGRocuronium
Rocuronium will be used for introduction in general anesthesia.
DRUGMorphine
Morphine will be administered bolus iv in General anesthesia group postoperatively before patients leave OR.
Sponsors
Larissa University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Caregiver)
Eligibility
Sex/Gender
ALL
Age
65 Years to 100 Years
Healthy volunteers
No
Inclusion criteria
* 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
Exclusion criteria
* 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 * Severe contraindication for antiplatelet agent discontinuation * Multiple failures * Receiving other coagulants * No written consent
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Mortality | 30 days | To compare postoperative 30-day mortality between General anesthesia and Regional anesthesia group |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Major Cardiovascular Events | 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 | 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. |
| Change in cognitive status | Cognitive function will be measured for both groups on admission (preop), 6 months and 12 months postop | 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 |
| Delirium | 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) | 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. |
| Adverse events postoperatively | 30 days | Occurrence of adverse events in both General anesthesia and Regional anesthesia groups, especially respiratory, renal, surgical trauma in 30 days postoperatively. |
| Re-admissions | 30 days | Re admissions in both General anesthesia and Regional anesthesia groups in 30 days postoperatively. |
| Postoperative analgesic use | 30 days | 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). |
| Time of hospitalization | 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 | To check and compare in both General anesthesia and Regional anesthesia groups time to hospital discharge. |
| Adverse events intraoperatively | During operation time frame | 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 |
| Functionality in daily living | 6 months | To check and compare between both General anesthesia and Regional anesthesia groups 6 months postoperatively functionality using Instrumental Activities of Daily Living scale |
| Timed Up and Go Test (TUG) | Measurements will be assessed 1, 3 and 6 months postop | 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 |
| EQ-5D-5L (EuroQol group, 5 dimensions, 5 levels) | Measurements will be assessed at 1, 3 and 6 months postop | 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. |
| Oxford hip score | Measurements will be assessed at 1, 3 and 6 months postop | To assess function and pain in both General anesthesia and Regional anesthesia groups 1, 3 and 6 months postoperatively by using Oxford hip score |
Countries
Greece
Outcome results
None listed