Organ Protection for Coronary Artery Bypass Graft (CABG): Propofol Versus Desflurane

NCT00400790 | Completed

• 1 other identifier: 0608121
• Study Type: interventional
• Target: 182
• Locations: 1 country
• Sites: 1

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.

Conditions

Coronary Artery Bypass; Delirium; Dementia; Amnesia; Cognition Disorders; Morbidity

Keywords

neurocognitive decline; coronary artery bypass surgery; composite morbidity; postoperative care cost

Outcome Measures

Primary Outcomes (1)

• Postoperative cognitive decline

  3 months

Secondary Outcomes (3)

• 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

Interventions

propofol DRUG

Propofol used as the primary anaesthetic agent

desflurane DRUG

Desflurane used as the primary anaesthetic

Eligibility Criteria

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

You may qualify if:

• Coronary artery bypass surgery

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Melbourne: lead
• Baxter Healthcare Corporation: collaborator

Study Sites (1)

Royal Melbourne Hospital

Melbourne, Victoria, 3050, Australia

Location

MeSH Terms

Conditions

Delirium; Dementia; Amnesia; Cognition Disorders

Interventions

Propofol; Desflurane

Condition Hierarchy (Ancestors)

Confusion; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Neurocognitive Disorders; Mental Disorders; Brain Diseases; Central Nervous System Diseases; Memory Disorders

Intervention Hierarchy (Ancestors)

Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Ethyl Ethers; Ethers; Methyl Ethers; Hydrocarbons, Fluorinated; Hydrocarbons, Halogenated

Study Officials

• Colin F Royse, MBBS, MD

  Melbourne Health and University of Melbourne

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: November 16, 2006
• First Posted: November 17, 2006
• Study Start: September 1, 2007
• Primary Completion: January 1, 2010
• Study Completion: January 1, 2010
• Last Updated: June 29, 2010

Record last verified: 2010-01

Locations

AU (1)