Volatile Anaesthesia and Perioperative Outcomes Related to Cancer (VAPOR-C): A Feasibility Study
Overview
- Phase
- Phase 4
- Intervention
- Propofol
- Conditions
- Cancer, Breast
- Sponsor
- Peter MacCallum Cancer Centre, Australia
- Enrollment
- 169
- Locations
- 1
- Primary Endpoint
- 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.
- Status
- Completed
- Last Updated
- 3 years ago
Overview
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.
Investigators
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
- •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
Exclusion Criteria
- Not provided
Arms & Interventions
Propofol (TIVA)
Propofol-based total intravenous anaesthesia
Intervention: Propofol
Volatile
Volatile-based (isoflurane, sevoflurane or desflurane) general anaesthesia
Intervention: isoflurane, sevoflurane or desflurane
Outcomes
Primary Outcomes
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.
Time Frame: 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.
Time Frame: 18 months
The study protocol will be assessed as feasible if a recruitment rate of at least 75% is achieved.
Secondary Outcomes
- 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)
- To test the efficiency of the centralized patient enrolment and computer randomization system.(18 months)