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临床试验/NCT00144118
NCT00144118终止4 期

Post-Operative Creatinine Changes In Patients With Pre-Existing Renal Impairment After Low-Flow Isoflurane Or Sevoflurane: A Randomised Clinical Trial

Austin Health2 个研究点 分布在 1 个国家目标入组 270 人开始时间: 2002年1月最近更新:
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相关药物

试验速览

阶段
4 期
状态
终止
发起方
Austin Health
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

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

研究者

发起方
Austin Health
申办方类型
Other Gov

研究点 (2)

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