NCT01855542已完成不适用
The Aim of This Investigation is to Compare the Influence of 0.9% Saline and Plasmalyte Solution on Acid-base Balance and Electrolytes in Healthy Patients Undergoing Major Spine Surgeries.
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- base-excess
研究概览
简要总结
Chloride-rich isotonic crystalloid solutions have been shown to exert electrolyte imbalance and metabolic acidosis in critically ill patients. The aim of this investigation is to compare the influence of 0.9% saline and plasmalyte solution on acid-base balance and electrolytes in healthy patients undergoing major spine surgeries.
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 20 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •1.50 patients (aged 20-65) undergoing cervical or lumbar spine surgery who were diagnosed spinal stenosis involving more than tow spinal levels.
排除标准
- •1. ASA class III or IV
- •2. pregnancy
- •3. breast feeding
- •4. lack of mental weakness(including disabled)
- •5. using diuretics
- •6. respiratory insufficiency
- •7. metabolic acidosis or alkalosis
- •8. coagulation disorder
- •9. over hydtration
- •10. renal failure or serum creatinine \> 1.4mg/dl
- •11. anemia (Hemoglobin 9.0\ 145mEq/L)
- •13. Hyperkalemia (K\>5.5mEq/L)
- •14. psychological medication or any drugs that influences renal clearance
研究组 & 干预措施
0.9% saline
Experimental
In each group, patients received either 0.9% normal saline or plasmalyte solution until end of surgery.
干预措施: 0.9% normal saline (Other)
plasmalyte
Active Comparator
In each group, patients received either 0.9% normal saline or plasmalyte solution until end of surgery.
干预措施: plasmalyte (Other)
结局指标
主要结局
base-excess
时间窗: Change from baseline in base-excess at postoperative 12 h
次要结局
未报告次要终点
研究者
研究点 (1)
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