Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12605000796684
Ethics application status
Approved
Date submitted
13/12/2005
Date registered
16/12/2005
Date last updated
19/01/2006
Type of registration
Prospectively registered

Titles & IDs
Public title
Effect of TIVA versus Sevoflurane on the incidence of post operative nausea and vomiting following day case gynaecology surgery
Scientific title
Effect of TIVA versus Sevoflurane on the incidence of post operative nausea and vomiting following day case gynaecology surgery
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Post operative nausea and vomiting 955 0
Condition category
Condition code
Reproductive Health and Childbirth 1024 1024 0 0
Other surgery

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Total intravenous anaesthetic.

Prospective randomised trial.
Patients stratified into high and low risk.
The trial is to run over approximately 12 months.
Intervention code [1] 801 0
None
Comparator / control treatment
Sevoflurane/dolasetron.

Prospective randomised trial.
Patients stratified into high and low risk.
The trial is to run over approximately 12 months.
Control group
Active

Outcomes
Primary outcome [1] 1373 0
Nausea
Timepoint [1] 1373 0
Primary outcome [2] 1374 0
Vomiting
Timepoint [2] 1374 0
Secondary outcome [1] 2434 0
Anaesthetic time
Timepoint [1] 2434 0
Secondary outcome [2] 2435 0
Time in recovery and to discharge home
Timepoint [2] 2435 0
Secondary outcome [3] 2436 0
Time to first oral intake
Timepoint [3] 2436 0
Secondary outcome [4] 2437 0
Unplanned admissions
Timepoint [4] 2437 0

Eligibility
Key inclusion criteria
General anaesthetic. Day case gynaecology surgery.
Minimum age
18 Years
Maximum age
Not stated
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
ASA IV or V, allergies to study medication, pregnancy, breast feeding, psychiatric illness, epidurals, planned admission.

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Opaque concealed sequencially numbered envelope
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Computer generated random sequence
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
1/11/2006
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
130
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 1127 0
Self funded/Unfunded
Name [1] 1127 0
Country [1] 1127 0
Primary sponsor type
Individual
Name
Hayden White
Address
Country
Secondary sponsor category [1] 984 0
None
Name [1] 984 0
none
Address [1] 984 0
Country [1] 984 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 2443 0
QE II Hospita
Ethics committee address [1] 2443 0
Kessels Rd Coopers Plain QLD 4108
Ethics committee country [1] 2443 0
Australia
Date submitted for ethics approval [1] 2443 0
Approval date [1] 2443 0
Ethics approval number [1] 2443 0

Summary
Brief summary
Rational for project

Many studies have investigated the treatment of post operative nausea and vomiting (PONV)

However, there is disagreement on both the incidence of PONV and how to prevent it

Few studies have investigated the period post discharge

Day case gynaecological surgery patients are particularly at risk of PONV

There is evidence that total intravenous anaethesia may decrease the incidence of PONV

This study sets out to investigate a specific subgroup of high risk patients. This will allow for specific recommendations to be made regarding the management of this subgroup of patients.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 35570 0
Address 35570 0
Country 35570 0
Phone 35570 0
Fax 35570 0
Email 35570 0
Contact person for public queries
Name 9990 0
Hayden White
Address 9990 0
2 Avinia Place
Westlake QLD 4074
Country 9990 0
Australia
Phone 9990 0
+61 415658824
Fax 9990 0
Email 9990 0
hayden_white@health.qld.gov.au
Contact person for scientific queries
Name 918 0
Hayden White
Address 918 0
2 Avinia Place
Westlake QLD 4074
Country 918 0
Australia
Phone 918 0
+61 415658824
Fax 918 0
Email 918 0
hayden_white@health.qld.gov.au

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.