- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04074460
Volatile Anaesthesia and Perioperative Outcomes Related to Cancer Feasibility Study (VAPOR-C)
Volatile Anaesthesia and Perioperative Outcomes Related to Cancer (VAPOR-C): A Feasibility Study
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Actual)
Phase
- Phase 4
Contacts and Locations
Study Locations
-
-
-
Melbourne, Australia
- Peter MacCallum Cancer Centre
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Propofol (TIVA)
Propofol-based total intravenous anaesthesia
|
General Anaesthesia
|
Active Comparator: Volatile
Volatile-based (isoflurane, sevoflurane or desflurane) general anaesthesia
|
General Anaesthesia
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
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.
Time Frame: 18 months
|
The study protocol will be assessed as feasible if a successful delivery rate of at least 90% is achieved.
|
18 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
18 months
|
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.
|
18 months
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Skin Diseases
- Respiratory Tract Diseases
- Neoplasms
- Lung Diseases
- Neoplasms by Site
- Breast Diseases
- Respiratory Tract Neoplasms
- Thoracic Neoplasms
- Breast Neoplasms
- Lung Neoplasms
- Physiological Effects of Drugs
- Central Nervous System Depressants
- Anesthetics, Intravenous
- Anesthetics, General
- Anesthetics
- Platelet Aggregation Inhibitors
- Hypnotics and Sedatives
- Anesthetics, Inhalation
- Propofol
- Desflurane
- Sevoflurane
- Isoflurane
Other Study ID Numbers
- 16/144
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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