Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12614000717651
Ethics application status
Approved
Date submitted
30/04/2014
Date registered
7/07/2014
Date last updated
15/11/2019
Date data sharing statement initially provided
15/11/2019
Date results provided
15/11/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
The effect of propofol versus etomidate on blood pressure stability in cardiac patients.
Scientific title
Propofol vs. Etomidate: Is Etomidate Haemodynamically Superior for Induction of Patients Undergoing Cardiac Surgery: a randomised, controlled trial
Secondary ID [1] 284504 0
None
Universal Trial Number (UTN)
Trial acronym
PET 1
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Haemodynamic stability during the first 10 minutes of aneathesia for cardiac surgery. 291764 0
Condition category
Condition code
Anaesthesiology 292122 292122 0 0
Other anaesthesiology

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
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.
Intervention code [1] 289263 0
Treatment: Drugs
Comparator / control treatment
Active control - propofol, standard alternative treatment to etomidate.
Control group
Active

Outcomes
Primary outcome [1] 292002 0
The area below the baseline pre-induction mean arterial blood pressure (MAP), i.e. the area between the MAP curve and the line of pre-induction MAP, over the first 10 min following induction. Baseline MAP is defined as the average pre-induction MAP taken over a 3 min period immediately prior to induction. MAP will be continuously measured via an intra-arterial catheter from time of insertion (normal practice, inserted at the start of case before induction) throughout each case, and compiled automatically (every 30 s) by the SaferSLEEP system (Safer Sleep LLC, Tennessee), which is used for all anaesthetics in our hospital.
Timepoint [1] 292002 0
The first 10 mins of the anaesthetic.
Secondary outcome [1] 307982 0
Key secondary outcome: The number of administrations of vasopressor agent over the first 10 minutes of surgery.
Timepoint [1] 307982 0
The first 10 minutes of the anaesthetic.
Secondary outcome [2] 307983 0
The effect of blinding of the induction agents on the above endpoints (primary and key secondary).
Timepoint [2] 307983 0
This outcome relates to the data collected for the primary and key secondary endpoints (which are collected over the first 10 mins of anaesthesia).

Eligibility
Key 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
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation will be concealed from the researcher at the time of screening/consenting. It will be provided post-enrolment by either an off site researcher, sealed opaque envelopes or a central randomisation computer.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Participants will be randomised in a 1:1 ratio to induction with either etomidate or propofol, with the randomisation stratified by anaesthetist and arranged in permuted blocks.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s

The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
All participants will be randomised to one or the other induction drug. All other aspects of the care will be the same (according to standard practice).
We will conduct the study in two phases.
Phase 1: all staff will be blinded to the study drug allocation, but the person administering the treatment (anaesthetist) will know the study drug allocation.
Phase 2: the study drug allocation will be concealed from all staff, including the person administering the treatment. This will allow us to assess whether the act of blinding alters the way in which anaesthetists give these drugs (and thereby potentially alter the stability of blood pressure during induction).
Phase
Phase 4
Type of endpoint/s
Pharmacodynamics
Statistical methods / analysis
The key efficacy measures (integral of MAP/time below a baseline defined by the pre-induction MAP, and use of vasoactive drugs within the first ten minutes after induction) will be compared between randomised groups with the stratification factor (anaesthetist) and whether the treatments were blinded as fixed factors. To test whether blinding alters the relative effects of the two randomised treatments, the interaction term (blinded treatment x randomised treatment) will be tested in the model. The MAP data will be compared between groups using a general linear model. The results will be summarised as the means difference and 95% confidence interval, derived from the general linear model. If the MAP area below pre-induction baseline is not adequately normally distributed then the data will be loge transformed prior to analysis. The use of vasoactive drugs within ten minutes of induction will be compared between groups using logistic regression. The effect will be summarised as the odds ratio with 95% confidence interval.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/08/2014
Actual
18/09/2014
Date of last participant enrolment
Anticipated
1/08/2015
Actual
16/07/2015
Date of last data collection
Anticipated
1/11/2015
Actual
25/08/2016
Sample size
Target
152
Accrual to date
Final
152
Recruitment outside Australia
Country [1] 6023 0
New Zealand
State/province [1] 6023 0
Auckland

Funding & Sponsors
Funding source category [1] 289148 0
Charities/Societies/Foundations
Name [1] 289148 0
The Green Lane Research and Educational Fund
Country [1] 289148 0
New Zealand
Primary sponsor type
University
Name
The University of Auckland
Address
Research Office
Building 620
Level 10
49 Symonds St,
Auckland, 1010
Country
New Zealand
Secondary sponsor category [1] 287814 0
Hospital
Name [1] 287814 0
Cardiothoracic Anaesthesia,
Auckland City Hospital
Address [1] 287814 0
Level 4,
Auckland City Hospital
2 Park Road,
Grafton
Auckland, 1023
Country [1] 287814 0
New Zealand

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 290921 0
Health and Disability Ethics Committees
Ethics committee address [1] 290921 0
Ethics committee country [1] 290921 0
New Zealand
Date submitted for ethics approval [1] 290921 0
12/05/2014
Approval date [1] 290921 0
28/05/2014
Ethics approval number [1] 290921 0
14/NTA/67

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 47986 0
Dr Cornelis Kruger
Address 47986 0
Cardiothoracic Anaesthesia,
Level 4,
Auckland City Hospital,
2 Park Road,
Grafton,
Auckland, 1023
Country 47986 0
New Zealand
Phone 47986 0
+64 307 4949 ext 23973
Fax 47986 0
Email 47986 0
[email protected]
Contact person for public queries
Name 47987 0
Jacqueline Hannam
Address 47987 0
Department of Anaesthesiology,
University of Auckland
Level 12, Auckland City Hospital,
2 Park Road,
Grafton,
Auckland, 1023
Country 47987 0
New Zealand
Phone 47987 0
+64 9 3737 599 ext 89308
Fax 47987 0
Email 47987 0
[email protected]
Contact person for scientific queries
Name 47988 0
Jacqueline Hannam
Address 47988 0
Department of Anaesthesiology,
University of Auckland
Level 12, Auckland City Hospital,
2 Park Road,
Grafton,
Auckland, 1023
Country 47988 0
New Zealand
Phone 47988 0
+64 9 3737 599 ext 89308
Fax 47988 0
Email 47988 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseHaemodynamic profiles of etomidate vs propofol for induction of anaesthesia: a randomised controlled trial in patients undergoing cardiac surgery.2019https://dx.doi.org/10.1016/j.bja.2018.09.027
N.B. These documents automatically identified may not have been verified by the study sponsor.