Post-Operative Creatinine Changes In Patients With Pre-Existing Renal Impairment After Low-Flow Isoflurane Or Sevoflurane: A Randomised Clinical Trial
试验速览
- 阶段
- 4 期
- 状态
- 终止
- 入组人数
- 270
- 试验地点
- 2
- 主要终点
- Change in creatinine in first three postoperative days
研究概览
简要总结
The purpose of this study is to determine if isoflurane and sevoflurane have similar effects on the kidneys of people with impaired kidneys when the drugs administered with low gas flow into anaesthetic machines.
详细描述
Study Protocol Post-Operative Creatinine Changes In Patients With Pre-Existing Renal Impairment After Low-Flow Isoflurane Or Sevoflurane: A Randomised Clinical Trial
Introduction
Sevoflurane is a volatile anaesthetic agent available for clinical use in most countries including Australia, the United States, the United Kingdom, and Canada. Since the first clinical use of sevoflurane in Japan during the 1980s, millions of anaesthetics have been given with sevoflurane. Sevoflurane has a number of advantages over other agents for general anaesthesia, particularly isoflurane. The benefits to patients and the environment include:
- A lower blood and tissue solubility allows patients to wake up faster after anaesthesia 1, 2.
- The lower blood solubility allows faster titration during surgery.
- Heart rate is more stable during increases in inspired concentration.
- Airway resistance is lower than with other volatile agents.
- A pleasant smell allows gas induction
- There is less nausea and vomiting than with isoflurane
- It is a fluorocarbon rather than a chlorofluorocarbon and does not worsen the atmospheric ozone hole.
The most important concern about sevoflurane is its effect on renal function due to breakdown products. When sevoflurane is exposed to the carbon dioxide absorbents soda lime and baralyme a vinyl breakdown product called Compound-A is formed. High dose exposure to Compound-A alters kidney histology in rats. Some, but not all, studies have found that Compound-A produces increases urinary secretion of renal tubule enzymes in humans. The clinical importance of enzyme secretion is unclear.
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
- Single
入排标准
- 年龄范围
- 18 Years 至 —(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult patients for elective surgery who will:
- •Need to stay at least one night, and
- •Need general anaesthesia, and
- •Have a pre-operative serum creatinine concentration greater than 130 umol/l.
排除标准
- •The patient refuses.
- •The patient is less than 18 years of age.
- •The patient is on pre-operative dialysis
- •The anaesthetist plans to use only regional or total intravenous anaesthesia.
- •Specific types of surgery: craniotomy, carotid, and cardiac.
结局指标
主要结局
Change in creatinine in first three postoperative days
次要结局
未报告次要终点
