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| Name | Class |
|---|---|
| M.D. Anderson Cancer Center | OTHER |
| Melbourne Health | OTHER |
| The Alfred | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Propofol (TIVA) | Active Comparator | Propofol-based total intravenous anaesthesia |
|
| Volatile | Active Comparator | Volatile-based (isoflurane, sevoflurane or desflurane) general anaesthesia |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Propofol | Drug | General Anaesthesia |
| |
| isoflurane, sevoflurane or desflurane |
| Measure | Description | Time Frame |
|---|---|---|
| To measure the ability to recruit eligible patients into the study. | The study protocol will be assessed as feasible if a recruitment rate of at least 75% is achieved. | 18 months |
| 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. | The study protocol will be assessed as feasible if a successful delivery rate of at least 90% is achieved. | 18 months |
| Measure | Description | Time Frame |
|---|---|---|
| To identify that all sites can capture data within the electronic case report form (eCRF) and utilize the electronic data capturing system (REDCap). | 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. |
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Inclusion Criteria:
Exclusion Criteria
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Peter MacCallum Cancer Centre | Melbourne | Australia |
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Patients are blinded to the anaesthetic type given. Statistician also blinded.
| Drug |
General Anaesthesia |
|
| 18 months |
| To test the efficiency of the centralized patient enrolment and computer randomization system. | 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. | 18 months |
| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| D003110 | Colonic Neoplasms |
| D011471 | Prostatic Neoplasms |
| D008175 | Lung Neoplasms |
| D008545 | Melanoma |
| D009369 | Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D015179 | Colorectal Neoplasms |
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D005834 | Genital Neoplasms, Male |
| D014565 | Urogenital Neoplasms |
| D005832 | Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D011469 | Prostatic Diseases |
| D052801 | Male Urogenital Diseases |
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D018358 | Neuroendocrine Tumors |
| D017599 | Neuroectodermal Tumors |
| D009373 | Neoplasms, Germ Cell and Embryonal |
| D009370 | Neoplasms by Histologic Type |
| D009380 | Neoplasms, Nerve Tissue |
| D018326 | Nevi and Melanomas |
| D012878 | Skin Neoplasms |
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| ID | Term |
|---|---|
| D015742 | Propofol |
| D007530 | Isoflurane |
| D000077149 | Sevoflurane |
| D000077335 | Desflurane |
| ID | Term |
|---|---|
| D010636 | Phenols |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D008738 | Methyl Ethers |
| D004987 | Ethers |
| D006845 | Hydrocarbons, Fluorinated |
| D006846 | Hydrocarbons, Halogenated |
| D005019 | Ethyl Ethers |
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