NCT06288815Unknown不适用
Comparison Efficacy of Oral Fluid Versus Intravenous Fluid Replacement in Postoperative Primary Total Knee Arthroplasty : A Randomized Controlled Trial.
适应症
干预措施
试验速览
- 阶段
- 不适用
- 入组人数
- 130
- 试验地点
- 1
- 主要终点
- Time to stand and walk
研究概览
简要总结
The goal of this study is to compared efficacy of oral fluid and intravenous fluid after primary unilateral total knee arthroplasty.
The main question it aims to answer is:
Does oral fluid replacement after primary unilateral total knee arthroplasty provide a patient recover faster than intravenous fluids replacement?
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 40 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 40-85 years old
- •ASA I, II
- •Primary osteoarthritis
排除标准
- •Diuretics use
- •Morbid obesity
- •Previous knee surgery
- •Cannot undergo spinal anesthesia
研究组 & 干预措施
Oral fluid
Experimental
- NPO (8hr for food, 2hr for water)
- Intraoperative IV fluid at least 1 liter
- Post operative (Off IV fluid, allow oral fluid as protocol at least 24hr)
干预措施: Oral fluid (Dietary Supplement)
IV fluid
Active Comparator
- NPO (8hr for food, 2hr for water)
- Intraoperative IV fluid at least 1 liter
- Post operative (IV fluid as protocol at least 24hr, allow oral fluid as usual)
干预措施: IV fluid (Dietary Supplement)
结局指标
主要结局
Time to stand and walk
时间窗: Postoperative day 1
Stand and walk with walker
次要结局
- the levels of blood urea nitrogen (BUN).(Postoperative day 1,2)
- Incidence of oliguria(Postoperative day 1,2)
- Incidence of nausea/vomiting(Postoperative day 1,2)
- Urine specific gravity(Postoperative day 1)
- Time up and go(24 and 48 hours)
- the levels of certain electrolytes(Postoperative day 1,2)
- the levels of creatinine(Postoperative day 1,2)
- Complications(Until postoperative 3months)
研究者
Yot Tanariyakul
Principle investigator
Thammasat University Hospital
研究点 (1)
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