Status:
COMPLETED
Volatile Anaesthesia and Perioperative Outcomes Related to Cancer Feasibility Study
Lead Sponsor:
Peter MacCallum Cancer Centre, Australia
Collaborating Sponsors:
M.D. Anderson Cancer Center
Melbourne Health
Conditions:
Cancer, Breast
Cancer Colorectal
Eligibility:
All Genders
18-80 years
Phase:
PHASE4
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 lo...
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 pa...
Eligibility Criteria
Inclusion
- 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.
Exclusion
Key Trial Info
Start Date :
August 27 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 30 2020
Estimated Enrollment :
169 Patients enrolled
Trial Details
Trial ID
NCT04074460
Start Date
August 27 2017
End Date
June 30 2020
Last Update
June 9 2022
Active Locations (1)
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1
Peter MacCallum Cancer Centre
Melbourne, Australia