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

Phase 3

Completed

• Conditions: cancer; Cancer - Any cancer; Anaesthesiology - Anaesthetics

• Registration Number: ACTRN12617001065381
• Lead Sponsor: Peter MacCallum Cancer Centre Office of Cancer Research

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2017-07-21
• Study Completion: 2020-08-21
• Last Update Posted: 30 May 2022

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 169

Inclusion Criteria

1. Male or female
2. Age 18-80 years.
3. Elective surgery
4. 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, or
Other major cancer surgeries (e.g. oesophagectomy, head and neck cancer, etc.)

Exclusion Criteria

1. Palliative surgery for end-stage disease with no curative intent
2. Emergency surgery
3. Extensive co-morbid disease, i.e. ASA >4
4. Refusal or inability to provide valid informed consent
5. Risk of severe postoperative nausea and vomiting (PONV risk score >3)
6. Previous allergy or contraindication to either anaesthetic medication
7. Indication for gas induction of anaesthesia

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To measure the ability to successfully deliver each of the two anaesthetic techniques (volatile-based general anaesthesia and TIVA-based anaesthesia) according to the research protocol. <br>Criteria: The study protocol will be assessed as feasible if a successful delivery rate of at least 90% is achieved. <br>'Successful delivery' is defined as delivery of the anaesthetic as per treatment arm for the entire operation, without limitation by correct equipment, or perioperative event indicating change from one anaesthetic technique to the other'.<br>[Primary endpoint will be measured at 6 months, or once all patients have been recruited, which ever occurs first.];To measure the ability to recruit eligible patients into the study. Criteria: The study protocol will be assessed as feasible if a recruitment rate of at least 75% is achieved.<br><br>[Primary endpoint will be measured at 6 months, or once all patients have been recruited, which ever occurs first.]