ED50 and ED95 of Intrathecal Bupivacaine With or Without Epinephrine for Total Knee Replacement Arthroplasty
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 162
- 试验地点
- 1
- 主要终点
- the success of anesthesia
研究概览
简要总结
This prospective randomized double-blind dose-response study is aimed to investigate the ED50 and ED95 of intrathecal bupivacaine with or without epinephrine 100 mcg for total knee replacement arthroplasty.
详细描述
Patients undergoing total knee replacement arthroplasty are randomly assigned to six bupivacaine dose group (6, 7, 8, 9, 10, 11 mg). Combined spinal-epidural anesthesia would be performed. The dose would be considered as successful if no epidural supplement was required during surgery. A probit analysis will be performed to calculate the ED50 and ED95 of intrathecal bupivacaine with or without epinephrine for total knee replacement arthroplasty.
After these measurements, ED50 and ED95 of bupivacaine with epinephrine would be compared with those without epinephrine.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 40 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •The patients with ASA class I or II scheduled for total knee replacement surgery
排除标准
- •Patients with previous spine surgery, diabetic and other neuropathy, skin infection at the site of injection, allergy to bupivacaine and other common contraindications for spinal anesthesia were excluded from this study.
研究组 & 干预措施
BPV9E1
干预措施: intrathecal bupivacaine 9 mg with 100 mcg of epinephrine (Drug)
BPV6E1
干预措施: intrathecal bupivacaine 6 mg with 100 mcg of epinephrine (Drug)
BPV7E1
干预措施: intrathecal bupivacaine 7 mg with 100 mcg of epinephrine (Drug)
BPV8E1
干预措施: intrathecal bupivacaine 8 mg with 100 mcg of epinephrine (Drug)
BPV10E1
干预措施: intrathecal bupivacaine 10 mg with 100 mcg of epinephrine (Drug)
BPV11E1
干预措施: intrathecal bupivacaine 11 mg with epinephrine 100 mcg (Drug)
BPV6E2
干预措施: intrathecal bupivacaine 6 mg with 200 mcg of epinephrine (Drug)
BPV7E2
干预措施: intrathecal bupivacaine 7 mg with 200 mcg of epinephrine (Drug)
BPV8E2
干预措施: intrathecal bupivacaine 8 mg with 200 mcg of epinephrine (Drug)
BPV9E2
干预措施: intrathecal bupivacaine 9 mg with 200 mcg of epinephrine (Drug)
BPV10E2
干预措施: intrathecal bupivacaine 10 mg with 200 mcg of epinephrine (Drug)
BPV11E2
干预措施: intrathecal bupivacaine 11 mg with 200 mcg of epinephrine (Drug)
结局指标
主要结局
the success of anesthesia
时间窗: during the surgery (average two hours)
The individual dose would be considered to be successful if no epidural supplement is required during surgery.
次要结局
- Adverse effects of the various intrathecal bupivacaine dose(during surgery (average two hours))
研究者
Won Ho Kim
Staff Anesthesiologist
Seoul Medical Center