Isoflurane During Cardiopulmonary Bypass

NCT02471950 | Completed

• 2 other identifiers: 15 LO 03662015/0199
• Study Type: observational
• Target: 22
• Locations: 1 country
• Sites: 1

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.

Conditions

Cardiopulmonary Bypass; Consciousness Monitors; Isoflurane

Outcome Measures

Primary Outcomes (1)

• Depth of anesthesia according to BIS

  BIS reading will be recorded at three time points during cardiopulmonary bypass

  Intraoperative

Secondary Outcomes (3)

• Comparison of exhaust gas and blood concentration of isoflurane

  Intraoperative

• Comparison of blood isoflurane concentration and BIS score

  Intraoperative

• Comparison of exhaust isoflurane Concentration and BIS score

  Intraoperative

Study Arms (1)

Elective Cardiac surgery

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

Procedure: 2.5 % Isoflurane administration

Interventions

2.5 % Isoflurane administration PROCEDURE

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

Elective Cardiac surgery

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Those patients scheduled for elective heart surgery over the age of 18 requiring cardiopulmonary bypass

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Edinburgh: lead

Study Sites (1)

Royal Infirmary of Edinburgh

Edinburgh, Scotland, EH16 4SA, United Kingdom

Location

Related Publications (1)

• 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.

  PMID: 30638148 RESULT

Biospecimen

Retention: SAMPLES WITH DNA

Arterial and venous blood samples

Study Officials

• Peter Alston, MBChB

  University of Edinburgh

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 1, 2015
• First Posted: June 15, 2015
• Study Start: April 1, 2015
• Primary Completion: January 1, 2019
• Study Completion: January 1, 2019
• Last Updated: June 21, 2021

Record last verified: 2021-06

Locations

GB (1)