Regional vs General Anesthesia in Patients With Hip Fracture Under Treatment With Clopidogrel
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 150
- 试验地点
- 1
- 主要终点
- Mortality
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Care Provider)
入排标准
- 年龄范围
- 65 Years 至 100 Years（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
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.
干预措施: Fentanyl (Drug)
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.
干预措施: Propofol (Drug)
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.
干预措施: Rocuronium (Drug)
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.
干预措施: Morphine (Drug)
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.
干预措施: Fentanyl (Drug)
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.
干预措施: Chirochaine (Drug)
结局指标
主要结局
Mortality
时间窗: 30 days
To compare postoperative 30-day mortality between General anesthesia and Regional anesthesia group
次要结局
- 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)
研究者
Aikaterini Tsiaka, MD
Consultant Anaesthesiologist
Larissa University Hospital