None listed
Conditions
Brief summary
Anaesthesia is largely standardised for cardiac patients undergoing surgery in the Green Lane Cardiac Unit at Auckland City Hospital. Anaesthesia is normally induced with either etomidate or propofol with relatively standardised use of co-induction agents such as midazolam and fentanyl. Currently there are approximately equal numbers of patients receiving propofol and etomidate. Etomidate is thought to be more stable for blood pressure than propofol in some patients. However, we do not know whether this is true. We wish to determine whether etomidate or propofol is the better drug to give for anaesthesia in cardiac patients, in terms of haemodynamic stability.
Interventions
Cardiac patients at our centre currently receive either iv propofol or intravenous (iv) etomidate for anaesthetic induction, depending on their anaesthetist's preference. We will randomise 152 study participants (stratified by attending anaesthetist) to receive either iv propofol (n=76) or iv etomidate (n=76) for anaesthetic induction. All operating room (OR) staff and postoperative care staff will be blinded to the randomisation. The study will be conducted in two phases.
Phase 1: During phase
Cardiac patients at our centre currently receive either iv propofol or intravenous (iv) etomidate for anaesthetic induction, depending on their anaesthetist's preference. We will randomise 152 study participants (stratified by attending anaesthetist) to receive either iv propofol (n=76) or iv etomidate (n=76) for anaesthetic induction. All operating room (OR) staff and postoperative care staff will be blinded to the randomisation. The study will be conducted in two phases. Phase 1: During phase 1, the anaesthetist will be aware of the study drug allocation (38 propofol, 38 etomidate, total n=76). Phase 2: During phase 2, the anaesthetist will also be blinded to the study drug allocation (38 propofol, 38 etomidate, total n=76). This study design will allow us to assess whether blinding the anaesthetist to the study drug in itself impacts our study outcome. All aspects of patient care, with the exception of the choice of induction drug, will be according to standard practice. Data will be collected directly from the patient notes, and extracted from the anaesthetic machine which automatically compiles physiological and dosing data during the anaesthetic.
Sponsors
The University of Auckland
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Males and females, age 18 years and over 2. ASA physical status II to IV undergoing cardiac surgery at the study site 3. Written, informed consent
Exclusion criteria
1. Known contraindication to etomidate or propofol 2. Poor (English) language comprehension and lack of an appropriate interpreter 3. Undergoing transplant surgery 4. Pregnancy
Outcome results
None listed