Volatile Anaesthesia and Perioperative Outcomes Related to Cancer Feasibility Study

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

169 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-08-27

Study Completion Date

2020-06-30

Brief Summary

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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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Detailed Description

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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.

Conditions

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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

DOUBLE

Participants Outcome Assessors

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

Study Groups

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Propofol (TIVA)

Propofol-based total intravenous anaesthesia

Group Type ACTIVE_COMPARATOR

Propofol

Intervention Type DRUG

General Anaesthesia

Volatile

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

Group Type ACTIVE_COMPARATOR

isoflurane, sevoflurane or desflurane

Intervention Type DRUG

General Anaesthesia

Interventions

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Propofol

General Anaesthesia

Intervention Type DRUG

isoflurane, sevoflurane or desflurane

General Anaesthesia

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No