The Influence of Body-mass Index on the Outcome of Spinal Anesthesia for Total Knee Replacement Arthroplasty
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 209
- 试验地点
- 1
- 主要终点
- spinal anesthetic success/ failure
研究概览
简要总结
In these prospective observational study, the investigators are trying to evaluate (1) the influence of body-mass index on spinal anesthetic outcome and (2) the determinants on spinal anesthetic outcome by logistic regression analysis.
详细描述
Although the spread of spinal anesthetic drug is unpredictable, patients factors (age, gender, height,weight, body-mass index), spinal anatomy, anesthetic drug dose, and lumbosacral cerebrospinal fluid volume are known to be the determinants of sensory block level. Among these determinants, the influence of body-mass index (BMI) on spinal anesthesia is controversial, and there is no specific guideline showing the relative priority of these determinants.
Therefore, in these prospective observational study, the investigators are trying to evaluate (1) the influence of body-mass index on spinal anesthetic outcome and (2) the relative influence of these determinants on spinal anesthetic outcome by logistic regression analysis.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 20 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients who are undergoing spinal anesthesia in Samsung Medical Center during study period
- •American Society of Anesthesiologist Physical Status classification I ~ III
排除标准
- •Bupivacaine allergy
- •medical history of spinal surgery
- •Diabetic neuropathy
- •active infection at the lumbosacral area
- •other contraindication of spinal anesthesia
研究组 & 干预措施
Obese group
patients with BMI >= 30.0 kg/m2 who received spinal anesthesia with heavy marcaine
干预措施: Spinal anesthesia (heavy bupivacaine) (Drug)
Non-obese group
patients with BMI < 30.0 kg/m2 who received spinal anesthesia with heavy marcaine
干预措施: Spinal anesthesia (heavy bupivacaine) (Drug)
结局指标
主要结局
spinal anesthetic success/ failure
时间窗: at 2 hour after the anesthetic induction
when (1) a bilateral T12 sensory block to pinprick within 15 minutes of intrathecal drug administration with sensory/motor block scale ≥ 2 and (2) the level of sensory block at the end of surgery was higher than or equal to T12 with sensory/motor block scale ≥ 2.
次要结局
- Incidence of hypotension, bradycardia(during 2 hours after anesthesia induction)
- Spinal anesthesia sensory/motor block level at the end of surgery(2 hours after induction (at the end of surgery))
- the incidence of tourniquet pain(at 90 min afer anesthetic induction)
- Peak level of sensory block at anesthesia induction(during 20 min after anesthetic induction)
研究者
Sangmin M. Lee
Professor
Samsung Medical Center