Cancer, Breast, Cancer Colorectal, Cancer, Lung, Cancer Melanoma Skin, Cancer, Other, Cancer Prostate
Conditions
Keywords
major surgeries lasting >2 hours
Brief summary
A multicentre, prospective randomized, active-controlled feasibility trial of volatile-based anaesthesia vs. propofol-based total intravenous anaesthesia to investigate the impact of anaesthesia on long-term (i.e. 5-years) patient cancer outcomes in patients undergoing elective major cancer surgery.
Detailed description
This study aims to assess the feasibility of conducting a phase IV, multi-centre, single-blinded, randomized control trial (VAPOR-C (Main)). Primary aims To measure the ability to recruit eligible patients into the study. To measure the ability to successfully deliver each of the two anaesthetic techniques (volatile-based general anaesthesia and propofol-based anaesthesia) according to the research protocol.
Interventions
DRUGPropofol
General Anaesthesia
General Anaesthesia
Sponsors
M.D. Anderson Cancer Center
Melbourne Health
The Alfred
Peter MacCallum Cancer Centre, Australia
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
DOUBLE (Subject, Outcomes Assessor)
Masking description
Patients are blinded to the anaesthetic type given. Statistician also blinded.
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* Male or female * Age 18-80 years * Elective surgery * Major cancer surgery expecting to last two or more hours, for: * Breast (mastectomy or segmentectomy plus sentinel node dissection) * Colorectal * Lung * Prostate * Melanoma (excision of melanoma plus lymph node dissection AND/OR skin flap construction * Other major cancer surgeries (e.g. oesophagectomy, head and neck cancer, etc.)
Exclusion criteria
* Palliative surgery for end-stage disease with no curative intent * Emergency surgery * Extensive comorbid disease, i.e. American Society of Anesthesiologists (ASA) Score \> 4 * Age \<18 or \>80 years old * Refusal or inability to provide valid informed consent * Risk of severe postoperative nausea and vomiting (PONV risk score \>3) * Previous allergy or contraindication to either anaesthetic medication * Indication for gas induction of anaesthesia * Currently enrolled in another clinical trial unless agreed by the coordinating principal investigator and site principal investigator that co-enrolment can occur.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| To measure the ability to recruit eligible patients into the study. | 18 months | The study protocol will be assessed as feasible if a recruitment rate of at least 75% is achieved. |
| To measure the ability to successfully deliver each of the two anaesthetic techniques (volatile-based general anaesthesia and propofol-based anaesthesia) according to the research protocol. | 18 months | The study protocol will be assessed as feasible if a successful delivery rate of at least 90% is achieved. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| To identify that all sites can capture data within the electronic case report form (eCRF) and utilize the electronic data capturing system (REDCap). | 18 months | All missing data to be recorded including reason for missing data, where available. Quantitative and qualitative analysis of reasons for missing data will be analysed by : Number of fields with missing data (percentage) and reason for missing data ( qualitative descriptor). Fields with \>1 missing data point will be analysed for reasons for failure. |
| To test the efficiency of the centralized patient enrolment and computer randomization system. | 18 months | Number of events of failed randomisation will be recorded on eCRF (under 'treatment of subjects). Quantitative analysis of failed randomisation (reported as %) as well as descriptive reason for failure will be recorded and analysed. This will allow shortcomings in the use of the computer-generated centralised randomisation program to be identified and ratified. |
Countries
Australia
Outcome results
None listed