Clinical trial NCT04074460: Volatile Anaesthesia and Perioperative Outcomes Related to Cancer Feasibility Study
Official title: Volatile Anaesthesia and Perioperative Outcomes Related to Cancer (VAPOR-C): A Feasibility Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Cancer, Breast
Cancer Colorectal
Cancer Prostate
Cancer, Lung
Cancer Melanoma Skin
Cancer, Other
Keywords: major surgeries lasting >2 hours
Lead sponsor: Peter MacCallum Cancer Centre, Australia
Sponsor class: OTHER
Collaborators: name: M.D. Anderson Cancer Center
name: Melbourne Health
name: The Alfred
First posted: 2019-08-30
Enrollment: 169
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: 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.

Eligibility 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.

Primary outcomes:
measure: To measure the ability to recruit eligible patients into the study.
timeFrame: 18 months
measure: 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.
timeFrame: 18 months
Secondary outcomes:
measure: To identify that all sites can capture data within the electronic case report form (eCRF) and utilize the electronic data capturing system (REDCap).
timeFrame: 18 months
measure: To test the efficiency of the centralized patient enrolment and computer randomization system.
timeFrame: 18 months
Other outcomes:
Locations:
city: Melbourne
country: Australia
facility: Peter MacCallum Cancer Centre
Study officials:
References: