NCT02471950

Isoflurane During Cardiopulmonary Bypass

The Depth of Anaesthesia Associated With the Use of 2.5% Isoflurane During Cardiopulmonary Bypass

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 22 (actual)
• Sponsor: University of Edinburgh · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Cardiopulmonary Bypass
• Consciousness Monitors
• Isoflurane

Interventions

Type	Name	Description
PROCEDURE	2.5 % Isoflurane administration	Anaesthesia maintained during cardiopulmonary bypass with 2.5% isoflurane administered via the oxygenator of the bypass circuit.

Timeline

• Start date: 2015-04-01
• Primary completion: 2019-01-01
• Completion: 2019-01-01
• First posted: 2015-06-15
• Last updated: 2021-06-21

Locations

1 site across 1 country: United Kingdom