The Effect of BMI on Median Effective Dose (ED50) of Intrathecal Hyperbaric Bupivacaine for Total Knee Replacement Arthroplasty
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 108
- 试验地点
- 1
- 主要终点
- success of spinal anesthesia
研究概览
简要总结
The effect of Body-mass index (BMI) on requirements of local anesthetics used in spinal anesthesia has not been well established. The investigators tried to quantify the effect of BMI on spinal anesthesia by comparing the median effective dose of intrathecal bupivacaine between two different BMI groups.
详细描述
The effect of BMI on requirements of local anesthetics used in spinal anesthesia has not been well established. The investigators tried to quantify the effect of BMI on spinal anesthesia by comparing the median effective dose (ED50)of intrathecal bupivacaine between two different BMI groups. The investigators determined the ED50 and ED 95 of intrathecal hyperbaric bupivacaine of subjects with BMI below 27.5 kg/m2, and subjects with BMI over 27.5 kg/m2, respectively. By comparing the difference of ED50 and ED95 between the groups, the investigators tried to quantify the effect of BMI on the bupivacaine dose requirement.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 盲法
- Double (Participant, Investigator)
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
- •Patients undergoing elective total knee replacement arthroplasty
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.
- •The patients with height less than 140 cm or more than 160 cm, body-mass index (BMI) less than 20 or greater than 35 were also excluded.
研究组 & 干预措施
BPV9NO
干预措施: BPV9NO (Drug)
BPV6NO
干预措施: BPV6NO (Drug)
BPV7NO
干预措施: BPV7NO (Drug)
BPV8NO
干预措施: BPV8NO (Drug)
BPV10NO
干预措施: BPV10NO (Drug)
BPV11NO
干预措施: BPV11NO (Drug)
BPV6O
干预措施: BPV6O (Drug)
BPV7O
干预措施: BPV7O (Drug)
BPV8O
干预措施: BPV8O (Drug)
BPV9O
干预措施: BPV9O (Drug)
BPV10O
干预措施: BPV10O (Drug)
BPV11O
干预措施: BPV11O (Drug)
结局指标
主要结局
success of spinal anesthesia
时间窗: every ten minutes during the surgery
a bilateral T12 sensory level to pinprick within 10 min of the intrathecal drug administration with no additional epidural anesthetics required during the surgery
次要结局
- time to first request for supplemental analgesia(every ten minutes during and after surgery)