The Effect of Propofol and Sevoflurane Anesthesia on Renal Function in Patients Undergoing Back Surgery
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 37
- 试验地点
- 1
- 主要终点
- Change in urine output
研究概览
简要总结
This study investigates the role of the anesthetic agents propofol and sevoflurane on renal function in otherwise healthy patients undergoing basic back surgery.
详细描述
Water-sodium homeostasis is central for anyone undergoing surgery, and can therefore affect surgical outcome, level of postoperative care and the length of hospital stay. Too much or too little fluid during surgery can affect the patients negatively. The kidneys play an imperative role in the regulation of water and sodium homeostasis, however there are lack of knowledge in how the anesthesia per se affects renal function. Previous studies have shown that volatile anesthetic agents such as sevoflurane can cause fluid retention. Why this happens is not completely known.
We are now investigating the different affects of sevoflurane and propofol anesthesia on renal function in patients undergoing basic back surgery to elucidate if there is a difference in the risk of developing acute kidney injury.
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 (Investigator)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Scheduled back surgery
排除标准
- •American Association of Anesthesiology class 1-3
- •American Heart Association class >3
- •Insulin treated diabetes
- •Pregnancy or breast feeding
- •Sensistivity/allergy against anesthetic agents
- •Inadequate understanding about the study
- •Depressed kidney function and/or AKI
- •Depressed liver function
- •Genetic malignant hyperthermia
研究组 & 干预措施
Sevoflurane
Intervention Back surgery and sevoflurane.
干预措施: Back Surgery (Procedure)
Sevoflurane
Intervention Back surgery and sevoflurane.
干预措施: Sevoflurane (Drug)
Propofol
Intervention Back surgery and propofol.
干预措施: Back Surgery (Procedure)
Propofol
Intervention Back surgery and propofol.
干预措施: Propofol (Drug)
结局指标
主要结局
Change in urine output
时间窗: 24 hours
Urine output (ml/min) changes during anesthesia, in postoperative care and in the ward unit. Changes will be assessed with AKIN RIFLE and by comparison between the different groups.
Change in serum creatinine levels
时间窗: 24 hours
Changes in serum creatinine levels during anesthesia, in postoperative care and in the ward unit. Changes will be assessed with AKIN RIFLE and by comparison between the different groups.
Change in creatinine clearance
时间窗: 24 hours
Creatinine clearance changes during anesthesia, in postoperative care and in the ward unit. Changes will be assessed with AKIN RIFLE and by comparison between the different groups.
次要结局
- Changes in electrolytes(24 hours)
- Changes in hormone levels(24 hours)
研究者
Robert Frithiof
MD PhD
Uppsala University