Volatile Anaesthesia and Perioperative Outcomes Related to Cancer Feasibility Study

NCT04074460 | Completed Phase 4

• 1 other identifier: 16/144
• Study Type: interventional
• Target: 169
• Locations: 1 country
• Sites: 1

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.

Conditions

Cancer, Breast; Cancer Colorectal; Cancer Prostate; Cancer, Lung; Cancer Melanoma Skin; Cancer, Other

Keywords

major surgeries lasting >2 hours

Outcome Measures

Primary Outcomes (2)

• 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.

  18 months

• 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.

  18 months

Secondary Outcomes (2)

• 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

Study Arms (2)

Propofol (TIVA)

ACTIVE COMPARATOR

Propofol-based total intravenous anaesthesia

Drug: Propofol

Volatile

ACTIVE COMPARATOR

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

Drug: isoflurane, sevoflurane or desflurane

Interventions

Propofol DRUG

General Anaesthesia

Propofol (TIVA)

isoflurane, sevoflurane or desflurane DRUG

General Anaesthesia

Volatile

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.)

You may not qualify if:

• 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.

Sponsors & Collaborators

• Peter MacCallum Cancer Centre, Australia: lead
• M.D. Anderson Cancer Center: collaborator
• Melbourne Health: collaborator
• The Alfred: collaborator

Study Sites (1)

Peter MacCallum Cancer Centre

Melbourne, Australia

Location

MeSH Terms

Conditions

Breast Neoplasms; Colonic Neoplasms; Prostatic Neoplasms; Lung Neoplasms; Melanoma; Neoplasms

Interventions

Propofol; Isoflurane; Sevoflurane; Desflurane

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Methyl Ethers; Ethers; Hydrocarbons, Fluorinated; Hydrocarbons, Halogenated; Ethyl Ethers

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: Patients are blinded to the anaesthetic type given. Statistician also blinded.
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 15, 2019
• First Posted: August 30, 2019
• Study Start: August 27, 2017
• Primary Completion: October 31, 2019
• Study Completion: June 30, 2020
• Last Updated: June 9, 2022

Record last verified: 2022-06

Data Sharing

• IPD Sharing: Will not share

Locations

AU (1)