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

Sponsor

Peter MacCallum Cancer Centre, Australia (Other)

Overall Status

Completed

CT.gov ID

NCT04074460

Collaborator

M.D. Anderson Cancer Center (Other), Melbourne Health (Other), The Alfred (Other)

169

Enrollment

Location

Arms

34.1

Actual Duration (Months)

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Cancer, Breast Cancer Colorectal Cancer Prostate Cancer, Lung Cancer Melanoma Skin Cancer, Other	Drug: Propofol Drug: isoflurane, sevoflurane or desflurane	Phase 4

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

169 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Outcomes Assessor)

Masking Description:

Patients are blinded to the anaesthetic type given. Statistician also blinded.

Primary Purpose:

Other

Official Title:

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

Actual Study Start Date :

Aug 27, 2017

Actual Primary Completion Date :

Oct 31, 2019

Actual Study Completion Date :

Jun 30, 2020

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Propofol (TIVA) Propofol-based total intravenous anaesthesia	Drug: Propofol General Anaesthesia
Active Comparator: Volatile Volatile-based (isoflurane, sevoflurane or desflurane) general anaesthesia	Drug: isoflurane, sevoflurane or desflurane General Anaesthesia

Arm

Intervention/Treatment

Active Comparator: Propofol (TIVA)

Propofol-based total intravenous anaesthesia

Drug: Propofol

General Anaesthesia

Active Comparator: Volatile

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

Drug: isoflurane, sevoflurane or desflurane

General Anaesthesia

Outcome Measures

Primary Outcome Measures

To measure the ability to recruit eligible patients into the study. [18 months]
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. [18 months]
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). [18 months]
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. [18 months]
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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 80 Years

Sexes Eligible for Study:

All

Accepts 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.