Clinical trial NCT03596060: Regional vs General Anesthesia in Patients With Hip Fracture Under Treatment With Clopidogrel
Official title: Regional vs General Anesthesia in Patients With Hip Fracture Under Treatment With Clopidogrel
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Hip Fractures
Keywords: hip fracture, general anesthesia, regional anesthesia, clopidogrel, cognitive impairment, mortality
Lead sponsor: Larissa University Hospital
Sponsor class: OTHER
First posted: 2018-07-23
Enrollment: 150
Sex: ALL
Minimum age (years): 65
Maximum age (years): 100
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Mortality
timeFrame: 30 days
Secondary outcomes:
measure: Major Cardiovascular Events
timeFrame: 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
measure: Change in cognitive status
timeFrame: Cognitive function will be measured for both groups on admission (preop), 6 months and 12 months postop
measure: Delirium
timeFrame: 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)
measure: Adverse events postoperatively
timeFrame: 30 days
measure: Re-admissions
timeFrame: 30 days
measure: Postoperative analgesic use
timeFrame: 30 days
measure: Time of hospitalization
timeFrame: 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
measure: Adverse events intraoperatively
timeFrame: During operation time frame
measure: Functionality in daily living
timeFrame: 6 months
measure: Timed Up and Go Test (TUG)
timeFrame: Measurements will be assessed 1, 3 and 6 months postop
measure: EQ-5D-5L (EuroQol group, 5 dimensions, 5 levels)
timeFrame: Measurements will be assessed at 1, 3 and 6 months postop
measure: Oxford hip score
timeFrame: Measurements will be assessed at 1, 3 and 6 months postop
Other outcomes:
Locations:
city: Larissa
country: Greece
facility: Larissa University Hospital
Study officials:
References: