Volatile Anaesthesia and Perioperative Outcomes Related to Cancer Feasibility Study

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Volatile Anaesthesia and Perioperative Outcomes Related to Cancer (VAPOR-C): A Feasibility Study

Conditions
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Cancer, Breast, Cancer Colorectal, Cancer Prostate, Cancer, Lung, Cancer Melanoma Skin, Cancer, Other

Intervention / Treatment
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* Drug: Propofol
* Drug: isoflurane, sevoflurane or desflurane


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Propofol (TIVA)<br>Propofol-based total intravenous anaesthesia | Drug: Propofol<br>* General Anaesthesia<br>|
| Active Comparator: Volatile<br>Volatile-based (isoflurane, sevoflurane or desflurane) general anaesthesia | Drug: isoflurane, sevoflurane or desflurane<br>* General Anaesthesia<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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. | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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major surgeries lasting >2 hours