Minimum Effective Dose of 0.5% Bupivacaine for Ultrasound-guided Spinal Anesthesia Using Taylor's Approach
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 56
- 试验地点
- 1
- 主要终点
- The minimum effective dose of bupivacaine in spinal anesthesia using Taylor's approach
研究概览
简要总结
This study aims to determine the minimum effective dose of bupivacaine 0.5% in 90% of patients undergoing lower limb surgery with ultrasound-guided spinal anesthesia using Taylor's approach. A biased coin design up-and-down sequential method is applied. The initial dose is 15 mg of bupivacaine 0.5%. After 45 successful spinal anesthesia, the ED90 of bupivacaine 0.5% will be calculated.
详细描述
The minimum effective dose of local anesthetics for spinal anesthesia using Taylor's approach is not known. This study aims to determine the minimum effective dose of bupivacaine 0.5% using a biased coin design up-and-down sequential method. Patients will receive real-time ultrasound guided spinal anesthesia using Taylor's approach. The initial dose is chosen as 15 mg on the basis of clinical experience. Subsequently, if a patient has an inadequate block, the bupivacaine dose is increased by 2 mg in the next subject. If a patient has a successful block, the next subject is randomized to receive either a lower dose (with a decrement of 2 mg), with a probability of b = 0.11, or the same dose, with a probability of 1 - b = 0.89. Forty five successful blocks will be accomplished. MED90 will be calculated by isotonic regression.
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, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •American Society of Anesthesiologists physical statusⅠ- Ⅲ
- •Lower limb surgery, expected operation time within 2 hours
排除标准
- •Patient refusal
- •American Society of Anesthesiologists physical status IV/V
- •Peripheral neuropathy
- •skin infection at the site of injection
- •allergy to bupivacaine or lidocaine
- •BMI > 35 kg/m2
- •coagulation disorders
研究组 & 干预措施
Deceasing
Spinal anesthesia with decreasing dose. Real-time ultrasound-guided spinal anesthesia Using Taylor's approach.
干预措施: spinal anesthesia (Procedure)
Similar
Spinal anesthesia with similar dose. Real-time ultrasound-guided spinal anesthesia Using Taylor's approach.
干预措施: spinal anesthesia (Procedure)
结局指标
主要结局
The minimum effective dose of bupivacaine in spinal anesthesia using Taylor's approach
时间窗: up to 6 months
The minimum effective dose of bupivacaine in spinal anesthesia using Taylor's approach is based on 45 successful spinal anesthesia performed in patients undergoing lower limb surgery.
次要结局
- postoperative neurological complications(up to 3 months postoperation)
- the duration of sensory spinal anaesthesia for the lower extremity(up to 3 days postoperation)
- the upper level of the sensory block 25 min after bupivacaine injection(25 min)
- the incidence of hypotension(during anethesia and operation)
研究者
Wei Mei
Vice Director, Department of Anaesthesiology, Tongji Hospital of Tongji Medical College
Huazhong University of Science and Technology