Hypobaric Lateral Spinal Anesthesia Versus General Anesthesia: Hemodynamic Stability and Short Term Cardiovascular Complications in Elderly Patients Undergoing Hip Fracture Surgery.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 154
- 试验地点
- 2
- 主要终点
- Number of episode of severe intraoperative hypotension
研究概览
简要总结
Hip fracture is a frequent pathology, involving elderly patients with many co-morbidities ; therefore, post-operative morbidity and mortality is high. It is reported that intra-operative hemodynamics correlate with post-operative complications such as myocardial injury after non-cardiac surgery (MINS) or acute kidney injury (AKI) ; that is why elderly patients undergoing hip fracture surgery should benefit from a better hemodynamic stability.
Low-dose hypobaric lateral spinal anesthesia with a reduced dose of local anesthetic has been shown to have better hemodynamic stability than conventional spinal anesthesia. It has also been reported that general anesthesia and conventional spinal anesthesia in elderly patients undergoing hip fracture surgery have the same hemodynamic effect. However, no published study has compared low-dose hypobaric lateral spinal anesthesia to general anesthesia with regards to hemodynamic effects.
The aim of the present study is to compare the intra-operative hemodynamics of low-dose hypobaric lateral spinal anesthesia with that of general anesthesia in elderly patients undergoing hip fracture surgery.
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
- None
入排标准
- 年龄范围
- 70 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •- Every patient aged 70 years or more who undergoes urgent surgery for a traumatic hip fracture.
排除标准
- •Patients younger than 70 years of age
- •Pathological fractures or multiple trauma
- •Contraindications to spinal anesthesia:
- •allergy to the local anesthetic
- •patients treated by clopidogrel (Plavix®)
- •patients treated by oral anticoagulants: dabigatran (Pradaxa®), rivaroxaban (Xarelto®), or apixaban (Eliquis®).
- •Coagulation disorders: (Prothrombin Time < 50 %, or Partial Thromboplastin Time ratio > 1.5, or platelets < 80 G/L),
- •Local infection of the puncture site
- •hyperthermia (> 38.5°C)
- •agitated patients
- •patients included in another study
- •patients under judicial protection
结局指标
主要结局
Number of episode of severe intraoperative hypotension
时间窗: At Day 0
Occurrence of an episode of severe hypotension defined as a mean arterial pressure (MAP) \< 65 mmHg for more than 12 minutes during the operative time.
次要结局
- Hospitalisation time(Up to 45 days after surgery)
- All-cause mortality(30 days after surgery)
- Myocardial injury after non cardiac surgery (MINS) occurence(3 days after surgery)
- Quantity of ephedrine used during the intervention(At Day 0)
- Number of episodes with a MAP < 65 mmHg for more than 12 minutes during operative time(At Day 0)
- Total time with MAP < 65 mmHg for more than 12 minutes during operative time(At Day 0)
- Acute kidney injury (AKI) occurence(3 days after surgery)
- Hemoglobin rate(3 days after surgery)
- Blood loss(At Day 0)
- Quantity of noradrenaline used during the intervention(At Day 0)
- Number of episode of severe hypotension in the recovery room.(At Day 0)