Trial Review

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial registered on ANZCTR


Registration number
ACTRN12617000810314
Ethics application status
Approved
Date submitted
28/05/2017
Date registered
2/06/2017
Date last updated
21/05/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
A Taste Test of Two Carbohydrate rich drinks for reducing preoperative starvation
Scientific title
A Taste Test of Two Carbohydrate rich drinks (PreOp and Dex) for reducing preoperative starvation in patients attending a pre-anaesthetic clinic.
Secondary ID [1] 292033 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Pre-Operative starvation 303473 0
Condition category
Condition code
Anaesthesiology 302884 302884 0 0
Anaesthetics

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Patients attending the pre- Anaesthetic clinic will be asked to taste two carbohydrate rich drinks used to reduce starvation before an anaesthetic and asked which one they prefer.
40 mls of either Drink A or B will be give and the patient in turn and they will be asked to rate the taste and if they will be asked if they think they could drink a full recommended volume of approx. 400mls.
They will then be given water to rinse the taste from their mouth.
40mls of the second drink will then be given to the patient and the same questions asked relating to the second drink.
The drinks are a 12.5% carbohydrate solution so a full 400ml drink is a load of 50g. The 40mls will therefore be a total of 5g of carbohydrate.
Intervention code [1] 298202 0
Prevention
Comparator / control treatment
Patients will be given both drinks to try and asked which one they prefer.
The order in which the drinks will be tasted will be randomised.
Control group
Active

Outcomes
Primary outcome [1] 302272 0
Patients will rate the taste on the 9-point Hedonic scale.
Timepoint [1] 302272 0
Rating will be asked immediately after tasting each drink.
Primary outcome [2] 302306 0
They will also be asked if they think they could drink a full 400ml "dose" - Yes or No
Timepoint [2] 302306 0
Immediately after drinking each drink
Primary outcome [3] 302307 0
The final question will ask which drink they prefer. A or B
Timepoint [3] 302307 0
Immediately after tasting both drinks
Secondary outcome [1] 335332 0
None
Timepoint [1] 335332 0
N/A

Eligibility
Key inclusion criteria
All patients attending the Pre-Anaesthetic clinic at Armidale Rural Referral Hospital during the trial period
Minimum age
10 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Communication difficulties that would mean the patient could not answer the questions posed.

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)
Sealed envelopes
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Randomisation done by coin toss and concealed envelopes.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
Intervention assignment
Crossover
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
19/06/2017
Actual
19/06/2017
Date of last participant enrolment
Anticipated
23/06/2017
Actual
26/06/2017
Date of last data collection
Anticipated
23/06/2017
Actual
26/06/2017
Sample size
Target
50
Accrual to date
Final
44
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 8199 0
Armidale Rural Referral Hospital - Armidale
Recruitment postcode(s) [1] 16258 0
2350 - Armidale

Funding & Sponsors
Funding source category [1] 296565 0
Hospital
Name [1] 296565 0
Armidale Rural Referral Hospital
Country [1] 296565 0
Australia
Primary sponsor type
Individual
Name
David Rowe
Address
Anaesthetic Department
Armidale Rural referral Hospital
Rusden Street
Armidale, NSW 2350
Country
Australia
Secondary sponsor category [1] 295554 0
None
Name [1] 295554 0
Address [1] 295554 0
Country [1] 295554 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 297782 0
Hunter New England Research Ethics & Governance Unit
Ethics committee address [1] 297782 0
Locked bag 1, New Lambton, NSW, 2305
Ethics committee country [1] 297782 0
Australia
Date submitted for ethics approval [1] 297782 0
27/01/2017
Approval date [1] 297782 0
26/04/2017
Ethics approval number [1] 297782 0
17/02/15/4.02

Summary
Brief summary
Carbohydrate rich clear fluids were added to the pre-operation fasting guidelines at our hospital in January 2015 to reduce the time from last calorie intake prior to surgery. 20% of patients indicated they did not like the drinks during an internal audit after the introduction of the drink. A new drink was launched in 2016 and we plan to ask our patients which drink they prefer with a view to increasing compliance.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 75094 0
Dr David Rowe
Address 75094 0
Anaesthetic Department
Armidale Rural referral Hospital
Rusden Street
Armidale, NSW 2350
Country 75094 0
Australia
Phone 75094 0
+61467677300
Fax 75094 0
Email 75094 0
[email protected]
Contact person for public queries
Name 75095 0
Dr David Rowe
Address 75095 0
Anaesthetic Department
Armidale Rural referral Hospital
Rusden Street
Armidale, NSW 2350
Country 75095 0
Australia
Phone 75095 0
+61467677300
Fax 75095 0
Email 75095 0
[email protected]
Contact person for scientific queries
Name 75096 0
Dr David Rowe
Address 75096 0
Anaesthetic Department
Armidale Rural referral Hospital
Rusden Street
Armidale, NSW 2350
Country 75096 0
Australia
Phone 75096 0
+61467677300
Fax 75096 0
Email 75096 0
[email protected]

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.