A Randomised Controlled Study of Organ Protection Comparing Desflurane and Propofol in Adult Patients Undergoing Coronary Artery Surgery With Cardiopulmonary Bypass
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- University of Melbourne
- Enrollment
- 182
- Locations
- 2
- Primary Endpoint
- Postoperative cognitive decline
Study Overview
Brief Summary
Background: Different anaesthetic agents have been shown to have different protective effects upon heart, brain and renal function under ischaemic conditions (oxygen starvation). Cardiopulmonary bypass takes over the work of the heart and the lungs during heart surgery, but oxygenation of vital organs such as the brain and heart may not be perfect, and can produce brain or heart damage as a consequence. Propofol and desflurane are commonly used anaesthetic agents, and there has been recent research to suggest that anaesthetic agents may provide some protection during periods where inadequate oxygenation occurs, with the potential to reduce the degree of organ damage. Both types of anaesthetics are used for cardiac surgery with anaesthetists choosing between them largely on the basis of personal preference.
Aim: To determine whether the use of either propofol or desflurane as the primary anaesthetic agent, can lead to differences in postoperative brain function, total morbidity or cost, following coronary artery surgery with cardiopulmonary bypass.
Methods: Patients will be recruited by professional research staff and will be randomised into one of two groups (90 in each group). They will receive a standardized technique for anaesthesia, cardiopulmonary bypass and postoperative ICU treatment. The only difference between the 2 groups will be as to which anaesthetic agent they receive during the surgical period, desflurane or propofol. Measurements will involve i) brain function testing before and 3 months after surgery ( a set of 10 verbal or manual tests), ii) incidence of delirium in the immediate postoperative period (a survey form), iii) incidence of total postoperative morbidity and iv) cost of hospital stay. Data collection will be by anaesthesia and research staff and a neuropsychologist will employed for performing the brain function testing.
Anticipated timeline: Initial recruitment completed by 15-18 months following trial commencement. Follow up completed 3 month after the last enrolment. Data validation, statistical analysis and manuscript preparation completed by 24 months.
Detailed Description
Aims To investigate whether there are differences in postoperative cognitive function, total morbidity or cost, following cardiac surgery determined by the use of either propofol or desflurane as the primary anaesthetic agent.
Hypothesis
The null hypothesis is that there are no differences in postoperative cognitive function, total morbidity or economic cost based on the type of primary anaesthetic delivered.
Participants: Following human ethics committee approval, and informed written consent, 180 patients undergoing elective cardiac surgery will be randomized to receive desflurane or propofol as the primary anaesthetic agent during surgery. This will be conducted at the Royal Melbourne Hospital. Data will be collected preoperatively, intraoperatively and throughout the entire hospital stay, and including a three-month follow-up.
Eligibility criteria
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Triple (Participant, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Coronary artery bypass surgery
Exclusion Criteria
- •Off-pump cardiac surgery
- •Require surgery for acute coronary syndrome
- •Dialysis dependent renal dysfunction
- •Severe liver dysfunction as determined by liver transaminases 1.5X greater than normal.
- •Pre-existing diagnosis of schizophrenia, dementia recent stroke or cognitive disorder
- •Recent alcohol/drug abuse/intoxication
- •Re-do Coronary Artery Grafts
- •Coronary Artery Grafts plus other surgery
Outcomes
Primary Outcomes
Postoperative cognitive decline
Time Frame: 3 months
Secondary Outcomes
- Delirium as defined using the Confusion Assessment Method(24 hours)
- Composite Morbidity(in hospital (average time 6-7 days))
- Cost of postoperative care(in hospital)