Clinical Characteristics of Spinal Levobupivacaine: Hyperbaric Compared With Isobaric Solution
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- time to T4-dermatome sensory blockade
研究概览
简要总结
The authors would like to investigate the blocking characteristics, surgical quality and side effects of intrathecal levobupivacaine whether there are any differences between the hyperbaric and the isobaric formulation for gynaecologic surgeries which need higher block level than the urological surgeries.
详细描述
The investigators study in the similar patients, give the same intervention except the baricity of levobupivacaine. The investigators record the level of sensory block and modified Bromage score for motor blockade.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •ASA I-III, aged 18-70 yr, scheduled for elective gynaecologic surgery, (total abdominal hysterectomy (TAH), TAH with uni-/bilateral salpingo-oophorectomy (SO), uni-/bilateral ovarian cystectomy, or myomectomy
排除标准
- •contraindications for spinal block, body mass index (BMI) more than 35 kg/m2 and height less than 150 cm
研究组 & 干预措施
isobaric levobupivacaine
spinal isobaric levobupivacaine
干预措施: isobaric levobupivacaine (Drug)
hyperbaric levobupivacaine
hyperbaric levobupivacaine
干预措施: hyperbaric levobupivacaine (Drug)
结局指标
主要结局
time to T4-dermatome sensory blockade
时间窗: 30 minutes
to investigate specific blocking characteristics of intrathecal hyperbaric levobupivacaine compared with isobaric levobupivacaine for gynaecologic surgery
次要结局
- side effects(1 to 4 hours intraoperation plus within 2 hours in the recovery room)
研究者
Vimolluck Sanansilp
Associate Professor
Mahidol University