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

Primary Purpose

Cancer, Breast, Cancer Colorectal, Cancer Prostate

Status
Completed
Phase
Phase 4
Locations
Australia
Study Type
Interventional
Intervention
Propofol
isoflurane, sevoflurane or desflurane
Sponsored by
Peter MacCallum Cancer Centre, Australia
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Cancer, Breast focused on measuring major surgeries lasting >2 hours

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Peter MacCallum Cancer Centre

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Propofol (TIVA)

Volatile

Arm Description

Propofol-based total intravenous anaesthesia

Volatile-based (isoflurane, sevoflurane or desflurane) general anaesthesia

Outcomes

Primary Outcome Measures

To measure the ability to recruit eligible patients into the study.
The study protocol will be assessed as feasible if a recruitment rate of at least 75% is achieved.
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.
The study protocol will be assessed as feasible if a successful delivery rate of at least 90% is achieved.

Secondary Outcome Measures

To identify that all sites can capture data within the electronic case report form (eCRF) and utilize the electronic data capturing system (REDCap).
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.
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.

Full Information

First Posted
August 15, 2019
Last Updated
June 8, 2022
Sponsor
Peter MacCallum Cancer Centre, Australia
Collaborators
M.D. Anderson Cancer Center, Melbourne Health, The Alfred
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1. Study Identification

Unique Protocol Identification Number
NCT04074460
Brief Title
Volatile Anaesthesia and Perioperative Outcomes Related to Cancer Feasibility Study
Acronym
VAPOR-C
Official Title
Volatile Anaesthesia and Perioperative Outcomes Related to Cancer (VAPOR-C): A Feasibility Study
Study Type
Interventional

2. Study Status

Record Verification Date
June 2022
Overall Recruitment Status
Completed
Study Start Date
August 27, 2017 (Actual)
Primary Completion Date
October 31, 2019 (Actual)
Study Completion Date
June 30, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Peter MacCallum Cancer Centre, Australia
Collaborators
M.D. Anderson Cancer Center, Melbourne Health, The Alfred

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cancer, Breast, Cancer Colorectal, Cancer Prostate, Cancer, Lung, Cancer Melanoma Skin, Cancer, Other
Keywords
major surgeries lasting >2 hours

7. Study Design

Primary Purpose
Other
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Masking Description
Patients are blinded to the anaesthetic type given. Statistician also blinded.
Allocation
Randomized
Enrollment
169 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Propofol (TIVA)
Arm Type
Active Comparator
Arm Description
Propofol-based total intravenous anaesthesia
Arm Title
Volatile
Arm Type
Active Comparator
Arm Description
Volatile-based (isoflurane, sevoflurane or desflurane) general anaesthesia
Intervention Type
Drug
Intervention Name(s)
Propofol
Intervention Description
General Anaesthesia
Intervention Type
Drug
Intervention Name(s)
isoflurane, sevoflurane or desflurane
Intervention Description
General Anaesthesia
Primary Outcome Measure Information:
Title
To measure the ability to recruit eligible patients into the study.
Description
The study protocol will be assessed as feasible if a recruitment rate of at least 75% is achieved.
Time Frame
18 months
Title
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.
Description
The study protocol will be assessed as feasible if a successful delivery rate of at least 90% is achieved.
Time Frame
18 months
Secondary Outcome Measure Information:
Title
To identify that all sites can capture data within the electronic case report form (eCRF) and utilize the electronic data capturing system (REDCap).
Description
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.
Time Frame
18 months
Title
To test the efficiency of the centralized patient enrolment and computer randomization system.
Description
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.
Time Frame
18 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
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.
Facility Information:
Facility Name
Peter MacCallum Cancer Centre
City
Melbourne
Country
Australia

12. IPD Sharing Statement

Plan to Share IPD
No

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Volatile Anaesthesia and Perioperative Outcomes Related to Cancer Feasibility Study

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