None listed
Conditions
Brief summary
This is a randomized, multicentre, open-label, blinded-endpoint feasibility trial designed to evaluate the safety and efficacy of an anaesthetic regimen incorporating methadone in combination with magnesium, ketamine, lidocaine, and dexmedetomidine in the context of fast-track cardiac anaesthesia (FTCA). It represents the first investigation to assess this specific multimodal protocol in cardiac surgical patients. Eligible participants will be adults (>18 years) undergoing elective, low-risk cardiac surgery requiring cardiopulmonary bypass. Consenting subjects will be randomized to receive either the FTCA intervention protocol or standard anaesthetic care. The primary hypothesis is that the intraoperative administration of intravenous dexmedetomidine and methadone, as part of a multimodal anaesthetic strategy, will reduce time to postoperative tracheal extubation and shorten intensive care unit length of stay, compared with usual care. Secondary outcomes include feasibility measures and safety endpoints relevant to implementing this anaesthetic approach in a multicentre setting. Recruiting hospitals: Austin Hospital, Epworth Eastern Hospital and Warringal Private Hospitals Number of participants planned: 100
Interventions
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 conducte
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.
Sponsors
Austin Health
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Prevention
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
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%
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)
Outcome results
None listed