Volatile Anaesthesia and Perioperative Outcomes Related to Cancer Feasibility Study

Phase 4

Completed

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

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.

Recruitment & Eligibility

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.

Arm && Interventions

Group	Intervention	Description
Volatile	isoflurane, sevoflurane or desflurane	Volatile-based (isoflurane, sevoflurane or desflurane) general anaesthesia
Propofol (TIVA)	Propofol	Propofol-based total intravenous anaesthesia

Primary Outcome Measures

Name	Time	Method
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.
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.

Secondary Outcome Measures

Name	Time	Method
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.