Regional vs General Anesthesia in Patients With Hip Fracture Under Treatment With Clopidogrel
Overview
- Phase
- Not Applicable
- Intervention
- Fentanyl
- Conditions
- Hip Fractures
- Sponsor
- Larissa University Hospital
- Enrollment
- 150
- Locations
- 1
- Primary Endpoint
- Mortality
- Last Updated
- 4 years ago
Overview
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.
Investigators
Aikaterini Tsiaka, MD
Consultant Anaesthesiologist
Larissa University Hospital
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
Arms & Interventions
General anesthesia
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.
Intervention: Fentanyl
General anesthesia
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.
Intervention: Propofol
General anesthesia
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.
Intervention: Rocuronium
General anesthesia
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.
Intervention: Morphine
Regional anesthesia
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.
Intervention: Fentanyl
Regional anesthesia
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.
Intervention: Chirochaine
Outcomes
Primary Outcomes
Mortality
Time Frame: 30 days
To compare postoperative 30-day mortality between General anesthesia and Regional anesthesia group
Secondary Outcomes
- 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)
- Postoperative analgesic use(30 days)
- Functionality in daily living(6 months)
- EQ-5D-5L (EuroQol group, 5 dimensions, 5 levels)(Measurements will be assessed at 1, 3 and 6 months postop)
- Oxford hip score(Measurements will be assessed at 1, 3 and 6 months postop)
- Re-admissions(30 days)
- Change in cognitive status(Cognitive function will be measured for both groups on admission (preop), 6 months and 12 months postop)
- Adverse events postoperatively(30 days)
- Adverse events intraoperatively(During operation time frame)
- 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))
- 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)
- Timed Up and Go Test (TUG)(Measurements will be assessed 1, 3 and 6 months postop)