Regional vs General Anesthesia in Patients With Hip Fracture Under Treatment With Clopidogrel

Study Overview
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Brief Summary
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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.

Official Title
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Regional vs General Anesthesia in Patients With Hip Fracture Under Treatment With Clopidogrel

Conditions
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Hip Fractures

Intervention / Treatment
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* Drug: Fentanyl
* Drug: Propofol
* Drug: Rocuronium
* Drug: Chirochaine
* Drug: Morphine


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 65 Years
Maximum Age: 100 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: General anesthesia<br>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. | Drug: Fentanyl<br>* Fentanyl will be used for introduction in both regional and general anesthesia. It will also be used for general anesthesia maintenance.<br>Drug: Propofol<br>* Propofol will be used for introduction in general anesthesia.<br>Drug: Rocuronium<br>* Rocuronium will be used for introduction in general anesthesia.<br>Drug: Morphine<br>* Morphine will be administered bolus iv in General anesthesia group postoperatively before patients leave OR.<br>|
| Active Comparator: Regional anesthesia<br>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. | Drug: Fentanyl<br>* Fentanyl will be used for introduction in both regional and general anesthesia. It will also be used for general anesthesia maintenance.<br>Drug: Chirochaine<br>* Chirochaine 0.5% will be used in regional anesthesia.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mortality | To compare postoperative 30-day mortality between General anesthesia and Regional anesthesia group | 30 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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 | 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. | 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. | 30 days | 
| Re-admissions | Re admissions in both General anesthesia and Regional anesthesia groups in 30 days postoperatively. | 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). | 30 days | 
| Time of hospitalization | To check and compare in both General anesthesia and Regional anesthesia groups time to hospital discharge. | 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 | 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 | 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 | 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. | 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 | Measurements will be assessed at 1, 3 and 6 months postop | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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hip fracture, general anesthesia, regional anesthesia, clopidogrel, cognitive impairment, mortality