The Depth of Anaesthesia Associated With the Use of 2.5% Isoflurane During Cardiopulmonary Bypass
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 22
- 试验地点
- 1
- 主要终点
- Depth of anesthesia according to BIS
研究概览
简要总结
There is no clinical way of assessing the depth of anaesthesia while patients are on the heart-lung machine. A new method of measuring the depth of anaesthesia using brainwaves called the Bispectral index (BIS) has been developed and its use in cardiac surgery is now widespread. However BIS is also altered by patients body temperature. As cooling is common during heart surgery the use of BIS to measure the depth of anaesthesia during heart-lung bypass remains controversial. This study aims to find out what depth of anaesthesia is produced according to BIS during heart lung bypass using a standard anaesthetic technique that utilises the anaesthetic isoflurane.
详细描述
There is no clinical way of assessing patients' depth of anaesthesia on the heart-lung machine. For this reason, the amount of volatile anaesthetic agent like isoflurane, that is administered has traditionally been determined by anaesthetists' clinical experience. Recently, a device that assesses depth of anaesthesia by analysing the electrical brain waves called the Bispectral index (BIS) has been introduced. The study aims to determine whether the level of anaesthesia produced by isoflurane using the traditional approach is more than required simply to maintain unconsciousness according to BIS. In addition, the study will determine whether the concentration of isoflurane in exhaust gases from the heart-lung machine can be used as an estimate arterial blood concentration and so, depth of anaesthesia.
The study will recruit patients who are scheduled for heart surgery using a heart-lung machine. Patients will be anaesthetised using a long established balanced technique including the administration of isoflurane 2.5% whilst supported on the heart-lung machine. Measurements of exhaust gas concentration of isoflurane from the heart-lung machine and level of BIS will be recorded at three time points. Simultaneously, three arterial blood samples will be taken and the isoflurane concentration measured in these samples. The BIS levels will be averaged and the proportion of patients with a BIS below 40 (lower limit of normal) will be calculated. Concentrations of isoflurane in the exhaust gas of the heart-lung machine will be compared with blood concentrations of isoflurane and the both concentrations will be compared with the level of BIS to establish whether they can be used to assess depth of anaesthesia.
If this study finds that a large proportion of patients have more than adequate levels of anaesthesia, then future studies could explore whether administering lower concentrations of isoflurane improves outcome whilst maintaining anaesthesia.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •Participants over the age of 18
- •Scheduled for elective cardiac surgery under the care of trial anaesthetists
- •Patient has provided informed consent to participate
排除标准
- •Patients presenting for emergency cardiac surgery
- •Patients who will have cardiac surgery that does not require cardiopulmonary bypass
- •Unwilling/unable to provide informed consent
- •Patients under the age of 18
- •Anaesthesia undertaken by anaesthetists not involved in trial
结局指标
主要结局
Depth of anesthesia according to BIS
时间窗: Intraoperative
BIS reading will be recorded at three time points during cardiopulmonary bypass
次要结局
- Comparison of blood isoflurane concentration and BIS score(Intraoperative)
- Comparison of exhaust gas and blood concentration of isoflurane(Intraoperative)
- Comparison of exhaust isoflurane Concentration and BIS score(Intraoperative)