Effect of Nicardipine on Renal Function in Deliberate Hypotension
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 64
- 主要终点
- urine output
研究概览
简要总结
The aim of this study was to demonstrate the effect of nicardipine on renal function with creatinine clearance, serum cystatin C, urine output and fractional excretion of sodium during deliberate hypotension for spine surgery.
详细描述
To induce deliberate hypotension, pharmacological agents such as inhalation anesthetics, calcium channel blockers, beta-adrenergic blockers have been used alone or in combination. Nicardipine, classed as a calcium channel blocker, has a peripheral vasodilator effect via relaxation of smooth muscle fiber and sympathetic nerve inhibition. Nicardipine expands the renal artery and increases glomerular filtration rate. Previous studies reported the renal protective effect of nicardipine in cardiac surgery with cardiopulmonary bypass and robot-assisted laparoscopic surgery.
The aim of this study was to demonstrate the effect of nicardipine on renal function with creatinine clearance , serum cystatin C, urine output and fractional excretion of sodium during deliberate hypotension for spine surgery.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients undergoing anterior or posterior spine interbody fusion
排除标准
- •Patients with American Society of Anesthesiologists physical status III or IV
- •Liver dysfunction with aspartate transaminase/alanine transaminase greater than 60/60 IU/L
- •Cerebrovascular disease
- •Anemia of less than hematocrit 24%
- •Diabetes mellitus
- •Severe malnutrition
- •those diuretics or antihypertensive drugs
研究组 & 干预措施
Nicardipine and Remifentanil
intravenous nicardipine and remifentanil during deliberate hypotension
干预措施: Nicardipine (Drug)
Remifentanil
intravenous remifentanil during deliberate hypotension
干预措施: Nicardipine (Drug)
结局指标
主要结局
urine output
时间窗: after deliberate hypotension, and POD1
creatinine clearance
时间窗: after deliberate hypotension, and POD1
serum cystatin C
时间窗: before deliberate hypotension, after deliberate hypotension, and POD1
fractional excretion of sodium
时间窗: before deliberate hypotension, after deliberate hypotension, and POD1
次要结局
- Risk, injury, failure, loss, and end stage renal disease (RIFLE) criteria(before deliberate hypotension, after deliberate hypotension, and POD1)