跳至主要内容
临床试验/NCT02471001
NCT02471001已完成不适用

Coronary Sinus Blood Isoflurane Concentration in Patients Undergoing Heart Surgery

University of Edinburgh1 个研究点 分布在 1 个国家目标入组 23 人开始时间: 2015年9月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
23
试验地点
1
主要终点
Levels of Isoflurane in coronary sinus blood

研究概览

简要总结

In the last few years, anaesthetic agents, Isoflurane used in heart surgery have shown some benefits to reduce the risk of heart muscle damage. Many research studies have been conducted to reveal the benefit relationship between Isoflurane and the risk of heart muscle injury during heart surgery. However, there is a knowledge gap regarding the optimal level of Isoflurane concentration to confer the benefit of heart muscle-protective properties. Therefore, this study is conducted to answer that question by measuring the Isoflurane concentration in the blood vessels. It also assesses whether Isoflurane concentration in the blood is correlated to the oxygenator exhaust level of Isoflurane in the heart-lung machine.

详细描述

All patients who scheduled for an elective heart surgery in Royal Infirmary of Edinburgh using a heart-lung machine and the administration of ether-like anaesthetic, isoflurane will be recruited in this study. This is a pilot study to determine the concentration of isoflurane in heart muscle. Isaac and Michael (2005), Hill (1998), Julious (2005) have conducted survey/research to conclude that 30 sample sizes are adequate for a pilot study. Thus, investigators aim to recruit at least 30 sample sizes to allow data (standard deviation, mean etc.) used in sample size estimation for future studies.

The medical and surgical care plans for participants remain as usual in this study. In a normal practise, surgeons will insert a catheter into the blood vessels coming from the heart to deliver solution to stop the contraction of heart for heart procedure. At this moment, two blood samples of about two-teaspoonful in volume will be collected from the in-placed catheters in vein and aorta. Then, the blood samples will be sent to lab to measure the concentration of isoflurane in vein and aorta. Also, the reading of exhausted isoflurane gas on heart-lung machine are routinely monitored and recorded.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Cross Sectional

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

  • Age 18 years or older
  • Scheduled for elective cardiac surgery requiring cardiopulmonary bypass.
  • Anaesthetised using isoflurane as part of a balanced anaesthetic technique during heart-lung machine
  • Patient has consented to participate
  • Cardioplegia technique involves insertion of a coronary sinus catheter.

排除标准

  • Emergency surgery or patient with malignancy
  • Heart surgery undertaken without heart-lung machine
  • Age younger than 18 years
  • Unable or unwilling to provide informed consent
  • Cardiac surgery that does not require cardiopulmonary bypass
  • Anaesthetised using an total intravenous-based technique

结局指标

主要结局

Levels of Isoflurane in coronary sinus blood

时间窗: 1 week after blood samples taken

次要结局

  • Isoflurane level in oxygenator exhaust levels on heart-lung machine(Immediately after the heart surgery is over)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

Loading locations...

相似试验

The Levels of Anaesthetics in Heart Muscle During... | 临床试验