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Trial registered on ANZCTR


Registration number
Help: Registration number
ACTRN12625001245482
Ethics application status
Help: Ethics application status
Approved
Date submitted
Help: Date submitted
26/10/2025
Date registered
Help: Date registered
7/11/2025
Date last updated
Help: Date last updated
14/10/2026
Date data sharing statement initially provided
Help: Data sharing statement date
7/11/2025
Type of registration
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Prospectively registered

Titles & IDs
Public title
Fast-track cardiac anaesthesia in adults undergoing elective cardiac surgery
Scientific title
Fast-track cardiac anaesthesia and early extubation pathway versus usual care for adults undergoing coronary artery bypass graft surgery: a two-centre pilot randomised controlled feasibility trial in Victoria, Australia
Additional trial identifiers [1] 315710 0
None
Universal Trial Number (UTN)
U1111-1330-5101
Trial acronym
Related trial records

Health condition
Health condition(s) studied:
Coronary artery disease 339412 0
Condition category
Condition code
Cardiovascular 335659 335659 0 0
Coronary heart disease
Cardiovascular 335660 335660 0 0
Diseases of the vasculature and circulation including the lymphatic system
Surgery 335661 335661 0 0
Surgical techniques
Anaesthesiology 335662 335662 0 0
Pain management
Anaesthesiology 335665 335665 0 0
Other anaesthesiology

Intervention/exposure
Study type
Interventional
Description of the intervention or exposure
This is a prospective randomised multicentre clinical trial of patients who are undergoing primary coronary artery bypass grafting (CABG) surgery via midline sternotomy.

The attending anaesthetist caring for the patient will administer all medications during the surgery. Medications will continue throughout surgery (expected duration 4-5 hours).

All medications, including doses) will be prescribed on the patients intraoperative anaesthesia chart. Adherence to the intervention will be conducted by a review of the anaesthetic chart,

The interventional group (Fastrack group) will receive the following medications:

No preoperative premedications.

At induction of anaesthesia:

1. Methadone - intravenously at induction of anaesthesia (0.1- 0.2 mg/kg IV)
2. Remifentanil (1-2 mcg/kg) for induction
3. Neuromuscular blocking agent: rocuronium (1 mg/kg) or vecuronium (0.1 mg/kg)

Maintenance anaesthesia/analgesia:

1.Dexmedetomidine IV 0.5 mcg/kg load over 30 minutes
2. Dexmedetomidine infusion 0.5 mcg/kg/h
3. Remifentanil infusion (0.1-0.3 mcg/kg/min or target control infusion at 3-6 ng/mL)
4. Propofol target controlled infusion (1-3 m/mL)
5. Maintenance of a patient state index (PSI) < 50 or bispectral index (BIS) < 60

Anaesthesia during cardio-pulmonary bypass (CPB):

1. Continue intraoperative remifentanil and dexmedetomidine infusions
2. Propofol or volatile anaesthesia maintaining a state index (PSI) less than 50 or bispectral index (BIS) greater than 60

Post CPB:

1. Additional analgesia with aliquots of intravenous fentanyl (50-100 µg)
2. Stop remifentanil during insertion of sternal wires
3. Start ketamine (0.05-0.1 mg/kg/h)
4. Paracetamol (1 g IV)
5. Sugammadex (200-400 mg IV) for reversal of neuromuscular blockade

At completion of surgery: the anaesthesia agents will be ceased and a spontaneous breathing trial will be initiated.

Tracheal extubation will occur either on the operating table or the patient will be transferred on propofol infusion (20-40 mg/h) to ICU for continuation of spontaneous breathing trial and extubation in ICU within 4 post-operative hours.
Intervention code [1] 332325 0
Treatment: Drugs
Description of the comparator or control
Patients randomised to the control group will receive all aspects of intraoperative care based on the discretion of treating anaesthetist.

At completion of surgery: the anaesthesia agents will be ceased and a spontaneous breathing trial will be initiated.

Tracheal extubation will occur either on the operating table or the patient will be transferred on propofol infusion (20-40 mg/h) to ICU for continuation of spontaneous breathing trial and extubation in ICU within 4 post-operative hours.
Control group
Active

Outcomes
Primary outcome [1] 347169 0
The primary outcome will be a composite of feasibility endpoints:
Timepoint [1] 347169 0
Immediately postoperatively, then 24 hours and 72 hours postoperatively, and through the intensive care and hospital admission. This assessment will be carried out at the conclusion of the study.
Secondary outcome [1] 453660 0
A composite of safety complications related to the study drugs:
Timepoint [1] 453660 0
Immediately postoperatively, then 24 hours and 72 hours postoperatively, and through the intensive care and hospital admission
Secondary outcome [2] 453661 0
Tracheal intubation
Timepoint [2] 453661 0
From completion of surgery to successful tracheal extubation
Secondary outcome [3] 453662 0
Post-operative ventilation time
Timepoint [3] 453662 0
From completion of surgery to discontinuation of mechanical ventilation
Secondary outcome [4] 453663 0
Tracheal Reintubation
Timepoint [4] 453663 0
From completion of surgery to 24 hours post surgery
Secondary outcome [5] 453664 0
Total consumption of opioids post-operatively
Timepoint [5] 453664 0
Measured at 24 and 48 hours postoperatively
Secondary outcome [6] 453665 0
Length of intensive care stay
Timepoint [6] 453665 0
Number of days admitted to ICU post surgery to discharge to the ward
Secondary outcome [7] 453666 0
Length of stay in hospital
Timepoint [7] 453666 0
From admission to ICU to hospital discharge.
Secondary outcome [8] 469247 0
The proportion of patients with successful tracheal extubation within 4 hours post-operatively.
Timepoint [8] 469247 0
Immediately postoperatively, then within 4 hours postoperatively. This assessment will be carried out at the conclusion of the study.
Secondary outcome [9] 469248 0
Hopsital readmission within 30 days after discharge
Timepoint [9] 469248 0
From hospital discharge to 30 days postoperatively

Eligibility
Key inclusion criteria
This key inclusion criteria will include:

1. Adult patients aged 18 years and over
2. Elective cardiac surgery
3. Undergoing primary coronary artery bypass grafting (CABG) surgery
4. Requiring sternotomy
5. Requiring cardiopulmonary bypass
6. Left ventricular ejective fraction of 50% or greater
7. EuroSCORE II less than 6%
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Healthy volunteers
No
Key exclusion criteria
The key exclusion criteria will be:

1. If methadone or dexmedetomidine will be used by the anaesthetist as part of their standard anaesthesia technique
2. Allergy to methadone or dexmedetomidine
3. Use of regional anaesthesia (i.e.. paravertebral and interscalene blocks)
4. Redo-cardiac surgery
5. Impaired left ventricular ejection function (LVEF less than 50% or New York Heart Association class (NYHA) greater than III)
6. Impaired right ventricular function (Fractional area change (FAC) less than 35%, tricuspid annular plane systolic excursion (TAPSE) less than 16mm and S' wave velocity less than 10cm/s)
7. Preoperative cardiac assist device in situ
8. Moderate pulmonary hypertension (mean pulmonary artery pressure (defined as greater than 40 mmHg)
9. Renal dysfunction (chronic kidney disease- serum creatinine ratio greater than 200 ug/L or estimated glomerular filtration rate (eGFR) less than 65 mL/min/body surface area
10. Deranged liver function tests (greater than 1..5 times the normal reference range)
11. Respiratory dysfunction (measure by respiratory function tests less than 50% of the patients predicted values)
12. History of seizure or stroke
13. Super obesity (Body Mass Index greater than 50 kg/m2)
14. Patients operated after 6 pm (due to reluctance to extubate patients at night)

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Patients will be informed about the study and consented at the preanaesthesia admission clinic 1-2 weeks prior to surgery. On the day of surgery, an independent anaesthetist or research nurse who is not a study investigator will open a sealed opaque randomisation envelope. The envelope will contain whether the patient has been randomised to the Usual Care group or the Fast-track group. A detailed page outlining the management of each group will be provided to the attending anaesthetist.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation by using a randomization table created by a computer software (i.e., computerised sequence generation) will be preformed. For each patient, an opaque envelope containing the group assignment will be prepared, sealed and sequentially numbered. On the morning of surgery the anaesthetist will open the envelope and randomised the patients into one of the two groups described above.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 3 / Phase 4
Type of endpoint/s
Efficacy
Statistical methods / analysis
Analysis will be undertaken by a statistical expert blinded to the intervention.

In general, descriptive statistics will be computed for all variables. Numeric variables will be described either as median and interquartile intervals 25–75% or mean and standard deviation. Categorical variables will be described as proportions. The distribution pattern of each variable will be assessed using the Kolmogorov–Smirnov test. Normally distributed continuous variables will be compared using T Student test and asymmetrically distributed variables compared using the Mann–Whitney test. Categorical variables will be analysed using chi square or Fisher’s exact test, as appropriate.

We will also perform appropriate regression to assess the association of fast-track cardiac surgery therapy with time to tracheal extubation adjusted by clinically and statistically variables. Similarly, we will conduct regression analyses to evaluate the association of FTCA adjusted for confounders. Adjusted odds ratios (ORs) with 95% confidence intervals (CIs) will be computed for all variables in all multivariable models, where appropriate. The independence of errors, presence of multicollinearity and the presence of influential assumptions will also be checked for any violations. A p value?of <?0.05 will be considered significant.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
14/11/2025
Actual
15/11/2025
Date of last participant enrolment
Anticipated
26/06/2026
Actual
16/06/2026
Date of last data collection
Anticipated
13/07/2026
Actual
14/08/2026
Sample size
Target
100
Accrual to date
Final
100
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 28741 0
Austin Health - Austin Hospital - Heidelberg
Recruitment hospital [2] 28742 0
Epworth Eastern Hospital - Box Hill
Recruitment postcode(s) [1] 44974 0
3128 - Box Hill

Funding & Sponsors
Funding source category [1] 320316 0
Hospital
Name [1] 320316 0
Austin Hospital Department of Anaesthesia Research Fund
Country [1] 320316 0
Australia
Primary sponsor type
Hospital
Name
Austin Health
Address
Country
Australia
Secondary sponsor category [1] 322890 0
None
Name [1] 322890 0
Address [1] 322890 0
Country [1] 322890 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 318864 0
Austin Health Human Research Ethics Committee
Ethics committee address [1] 318864 0
Ethics committee country [1] 318864 0
Australia
Date submitted for ethics approval [1] 318864 0
21/07/2022
Approval date [1] 318864 0
19/08/2022
Ethics approval number [1] 318864 0
HREC/86574/Austin-2022

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

Contacts
Principal investigator
Name 145486 0
Prof Laurence Weinberg
Address 145486 0
Department of Anaesthesia, Austin Hospital Studley Rd, Heidelberg Victoria, 3084, Australia
Country 145486 0
Australia
Phone 145486 0
+61 3 94943800
Fax 145486 0
Email 145486 0
[email protected]
Contact person for public queries
Name 145487 0
Professor Laurence Weinberg
Address 145487 0
Department of Anaesthesia, Austin Hospital Studley Rd, Heidelberg Victoria, 3084, Australia
Country 145487 0
Australia
Phone 145487 0
+61 3 94943800
Fax 145487 0
Email 145487 0
[email protected]
Contact person for scientific queries
Name 145488 0
Professor Laurence Weinberg
Address 145488 0
Department of Anaesthesia, Austin Hospital Studley Rd, Heidelberg Victoria, 3084, Australia
Country 145488 0
Australia
Phone 145488 0
+61 3 94943800
Fax 145488 0
Email 145488 0
[email protected]

Data sharing statement
Will the study consider sharing individual participant data?
Yes
Will there be any conditions when requesting access to individual participant data?
Persons/groups eligible to request access:
• Researchers
Conditions for requesting access:
• Yes, conditions apply:
• Requires a scientifically sound proposal or protocol
What individual participant data might be shared?
• All de-identified individual participant data
What types of analyses could be done with individual participant data?
• Systematic reviews and meta-analyses
• Studies exploring new research questions
• Health economic analyses
• Studies testing whether findings can be repeated or confirmed
When can requests for individual participant data be made (start and end dates)?
From:
After publication of main results
To:
No end date
Where can requests to access individual participant data be made, or data be obtained directly?
• Email of trial custodian, sponsor or committee: [email protected]

Are there extra considerations when requesting access to individual participant data?
No


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
No additional documents have been identified.