Isoflurane During Cardiopulmonary Bypass

NCT ID: NCT02471950

Last Updated: 2021-06-21

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 22 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2015-04-30
• Study Completion Date: 2019-01-31

Brief 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

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Elective Cardiac surgery

Those patients scheduled for elective heart surgery requiring cardiopulmonary bypass who will be given 2.5% isoflurane while on bypass.

2.5 % Isoflurane administration

Intervention Type: PROCEDURE

Anaesthesia maintained during cardiopulmonary bypass with 2.5% isoflurane administered via the oxygenator of the bypass circuit.

Interventions

2.5 % Isoflurane administration

Anaesthesia maintained during cardiopulmonary bypass with 2.5% isoflurane administered via the oxygenator of the bypass circuit.

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

• Participants over the age of 18
• Scheduled for elective cardiac surgery under the care of trial anaesthetists
• Patient has provided informed consent to participate

Exclusion Criteria

• 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Edinburgh

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Peter Alston, MBChB

Role: PRINCIPAL_INVESTIGATOR

University of Edinburgh

Locations

Royal Infirmary of Edinburgh

Edinburgh, Scotland, United Kingdom

Countries

United Kingdom

References

Alston RP, Connelly M, MacKenzie C, Just G, Homer N. The depth of anaesthesia associated with the administration of isoflurane 2.5% during cardiopulmonary bypass. Perfusion. 2019 Jul;34(5):392-398. doi: 10.1177/0267659118822946. Epub 2019 Jan 12.

Reference Type: RESULT

PMID: 30638148 (View on PubMed)

Other Identifiers

2015/0199

Identifier Type: OTHER

Identifier Source: secondary_id

15 LO 0366

Identifier Type: -

Identifier Source: org_study_id