Determining the Minimum Effective Ropivacaine Dose for Unilateral Hypobaric Spinal Anaesthesia During Traumatic Femoral Neck Surgery in the Aged Person: Prospective Comparative Randomized Study
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 64
- 试验地点
- 1
- 主要终点
- Determine the minimum effective ropivacaine dose for unilateral hypobaric spinal anaesthesia during traumatic femoral neck surgery.
研究概览
简要总结
This is a prospective, monocentric, randomized study, comparing the effectiveness and tolerance of four different dosages of hypobaric ropivacaine for unilateral spinal anaesthesia during traumatic femoral neck surgery in the elderly.
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, Investigator)
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
- •older than 70
- •dorsal decubitus surgery
- •ASA score 1, 2, 3
- •MMS score > or equal to 25
排除标准
- •local anesthetic allergy
- •spinal anaesthetic exclusion
- •MMS score lower than 25
研究组 & 干预措施
6 mg of ropivacaine
6 mg of ropivacaine are used for the spinal anaesthesia
干预措施: 6 mg of ropivacaine (Drug)
8 mg of ropivacaine
8 mg of ropivacaine are used for the spinal anaesthesia
干预措施: 8 mg of ropivacaine (Drug)
10 mg of ropivacaine
10 mg of ropivacaine are used for the spinal anaesthesia
干预措施: 10 mg of ropivacaine (Drug)
12 mg of ropivacaine
12 mg of ropivacaine are used for the spinal anaesthesia
干预措施: 12 mg of ropivacaine (Drug)
结局指标
主要结局
Determine the minimum effective ropivacaine dose for unilateral hypobaric spinal anaesthesia during traumatic femoral neck surgery.
时间窗: 1 hour (surgery intervention)
次要结局
- Patient and surgeon satisfaction(1 hour (surgery intervention))
- Morbidity and mortality(During 3 days after surgery)
- Hemodynamics consequences(1 hour (surgery intervention))
- Spinal anaesthesia characteristics(1 hour (surgery intervention))