Volatile Anaesthesia and Perioperative Outcomes Related to Cancer Feasibility Study (VAPOR-C)

Peter MacCallum Cancer Centre, Australia

Status and phase

Completed

Phase 4

Conditions

Cancer, Lung

Cancer Melanoma Skin

Cancer, Breast

Cancer Prostate

Cancer, Other

Cancer Colorectal

Treatments

Drug: Propofol

Drug: isoflurane, sevoflurane or desflurane

Study type

Interventional

Funder types

Other

Identifiers

NCT04074460

16/144

Details and patient eligibility

About

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.

Full 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.

Enrollment

169 patients

Sex

All

Ages

18 to 80 years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

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.