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NCT Number: NCT04074460

Volatile Anaesthesia and Perioperative Outcomes Related to Cancer Feasibility Study

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.

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Key information

Conditions

Cancer, Breast Breast Diseases Breast Neoplasms Cancer Colorectal Cancer Melanoma Skin Cancer Prostate Cancer, Lung Cancer, Other Colonic Diseases Colonic Neoplasms Colorectal Neoplasms Digestive System Diseases Digestive System Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms Genital Diseases Genital Diseases, Male Genital Neoplasms, Male Intestinal Diseases Intestinal Neoplasms Lung Diseases Lung Neoplasms Male Urogenital Diseases Melanoma Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Germ Cell and Embryonal Neoplasms, Nerve Tissue Neuroectodermal Tumors Neuroendocrine Tumors Nevi and Melanomas Prostatic Diseases Prostatic Neoplasms Respiratory Tract Diseases Respiratory Tract Neoplasms Skin Diseases Skin Neoplasms Skin and Connective Tissue Diseases Thoracic Neoplasms Urogenital Diseases Urogenital Neoplasms

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Peter MacCallum Cancer Centre

Melbourne, Australia

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Propofol

Drug

General Anaesthesia

isoflurane, sevoflurane or desflurane

Drug

General Anaesthesia

Primary outcomes

  1. 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.

  2. 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.

Secondary outcomes

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

    Time frame: 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.

  2. To test the efficiency of the centralized patient enrolment and computer randomization system.

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Peter MacCallum Cancer Centre, Australia

Other

Collaborators

  • M.D. Anderson Cancer Center
  • Melbourne Health
  • The Alfred

Registry information

Official study title

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

Acronym: VAPOR-C

Important dates

Study start
2017
Primary completion
2019
Study completion
2020
First posted
Aug 30, 2019
Registry last updated
Jun 9, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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