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

This study has been completed.
Sponsor:
Collaborator:
Baxter Healthcare Corporation
Information provided by:
University of Melbourne
ClinicalTrials.gov Identifier:
NCT00400790
First received: November 16, 2006
Last updated: June 28, 2010
Last verified: January 2010
  Purpose

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.


Condition Intervention
Coronary Artery Bypass
Delirium
Dementia
Amnesia
Cognition Disorders
Morbidity
Drug: propofol
Drug: desflurane

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Randomised Controlled Study of Organ Protection Comparing Desflurane and Propofol in Adult Patients Undergoing Coronary Artery Surgery With Cardiopulmonary Bypass

Resource links provided by NLM:


Further study details as provided by University of Melbourne:

Primary Outcome Measures:
  • Postoperative cognitive decline [ Time Frame: 3 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Delirium as defined using the Confusion Assessment Method [ Time Frame: 24 hours ] [ Designated as safety issue: No ]
  • Composite Morbidity [ Time Frame: in hospital (average time 6-7 days) ] [ Designated as safety issue: No ]
  • Cost of postoperative care [ Time Frame: in hospital ] [ Designated as safety issue: No ]

Enrollment: 182
Study Start Date: September 2007
Study Completion Date: January 2010
Primary Completion Date: January 2010 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: propofol
    Propofol used as the primary anaesthetic agent
    Drug: desflurane
    Desflurane used as the primary anaesthetic
  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00400790

Locations
Australia, Victoria
Royal Melbourne Hospital
Melbourne, Victoria, Australia, 3050
Sponsors and Collaborators
University of Melbourne
Baxter Healthcare Corporation
Investigators
Principal Investigator: Colin F Royse, MBBS, MD Melbourne Health and University of Melbourne
  More Information

No publications provided

Responsible Party: Colin Royse, University of Melbourne
ClinicalTrials.gov Identifier: NCT00400790     History of Changes
Other Study ID Numbers: 0608121
Study First Received: November 16, 2006
Last Updated: June 28, 2010
Health Authority: Australia: Department of Health and Ageing Therapeutic Goods Administration

Keywords provided by University of Melbourne:
neurocognitive decline
coronary artery bypass surgery
composite morbidity
postoperative care cost

Additional relevant MeSH terms:
Amnesia
Cognition Disorders
Delirium
Dementia
Memory Disorders
Neurobehavioral Manifestations
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Delirium, Dementia, Amnestic, Cognitive Disorders
Mental Disorders
Confusion
Brain Diseases
Central Nervous System Diseases
Propofol
Desflurane
Hypnotics and Sedatives
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Anesthetics, Intravenous
Anesthetics, General
Anesthetics
Anesthetics, Inhalation

ClinicalTrials.gov processed this record on August 20, 2014