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Trial registered on ANZCTR


Registration number
ACTRN12612000231842
Ethics application status
Approved
Date submitted
22/02/2012
Date registered
23/02/2012
Date last updated
23/02/2012
Type of registration
Prospectively registered

Titles & IDs
Public title
Effect of Fasting Time for Water on the Acidity and Volume of Stomach Content
Scientific title
Effect of Fasting Time for Water on Gastric pH and Volume in adult patients scheduled for elective gastroscopy
Secondary ID [1] 280016 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Fasting times for water before induction of anaesthesia 285927 0
Condition category
Condition code
Oral and Gastrointestinal 286115 286115 0 0
Normal oral and gastrointestinal development and function
Anaesthesiology 286118 286118 0 0
Anaesthetics

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Comparison of pH and volume of gastric content following two fasting protocols for water before anaesthesia

Arm 1: Standard fasting protocol (fasting for solids for 6 hours, fasting for clear fluids for 2 hours), 200ml water consumption at 45-60 mins prior to anaesthesia

Arm 2: Standard fasting protocol (fasting for solids for 6 hours, fasting for clear fluids for 2 hours), 200 ml water consumption at 90-150 mins prior to anaesthesia

Test water volume: 200ml (standard volume of drinking cup in hospital setting)
Intervention code [1] 284337 0
Treatment: Other
Intervention code [2] 284340 0
Prevention
Comparator / control treatment
Arm 2 is the control group whereby subjects follow a routine fasting protocol for water which is a minimum of 90 mins before anaesthesia.
Control group
Active

Outcomes
Primary outcome [1] 286589 0
Primary Endpoint 1: pH of gastric content
Timepoint [1] 286589 0
Upon aspiration of gastric content via gastroscope following induction of anaesthesia
Primary outcome [2] 286590 0
Primary Endpoint 2: Volume of gastric content
Timepoint [2] 286590 0
Upon aspiration of gastric content via gastroscope following induction of anaesthesia
Secondary outcome [1] 296223 0
Nil
Timepoint [1] 296223 0
Nil

Eligibility
Key inclusion criteria
Adult patients scheduled for elective gastrocopy
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Patients who
i) are under 18 years of age
ii) are not competent in English
iii) are pregnant
iv) have active upper gastrointestinal haemorrhage
v) have achalasia or gastric outlet obstruction
vi) have Insulin requiring Diabetes Mellitus
vii) has had previous gastric surgery

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)
Allocation concealment procedure si done by sealed opaque envelopes
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation by using a randomization table created by a computer software (i.e. computerised sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Safety
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/04/2012
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
90
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 284768 0
Self funded/Unfunded
Name [1] 284768 0
Country [1] 284768 0
Australia
Primary sponsor type
Hospital
Name
Monash Medical Centre
Address
246 Clayton Road
Clayton
VIC 3168
Country
Australia
Secondary sponsor category [1] 283659 0
None
Name [1] 283659 0
Nil
Address [1] 283659 0
Nil
Country [1] 283659 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 286763 0
Southern Health
Ethics committee address [1] 286763 0
246 Clayton Road
Clayton 3168
VIC
Ethics committee country [1] 286763 0
Australia
Date submitted for ethics approval [1] 286763 0
Approval date [1] 286763 0
09/02/2012
Ethics approval number [1] 286763 0
12011A

Summary
Brief summary
Fasting of solids and fluids before general anaesthesia is essential to patient safety in order to reduce the risk of the pulmonary aspiration. The high acidity of stomach contents upon aspiration can cause significant damage to lung tissue. The estimated incidence of pulmonary aspiration is low, ranging between 1/2000 to 1/14000 with morbidity relating to aspiration even lower ranging between 1/4000 to 1/99000.

Current fasting guidelines according to American Society of Anesthesiologists recommend a 2-hour fast for clear fluids before general anaesthesia. However, clear scientific evidence supporting this recommendation is lacking and the ideal fasting time and maximal permissible volume for water have yet to be determined.

New evidence suggests that water up to 450mls can be safely consumed up to 90 minutes before induction of anaesthesia and that stomach volumes are lower in those who had consumed preoperative water than those who had a fast of 6 hours. Others have demonstrated that preoperative water consumption can also decrease patient thirst and anxiety without adverse effects.

The proposed project aims to investigate the effect on stomach contents as measured by level of acidity and volume, following consumption of 200 ml of water up to 45 minutes before general anaesthesia.

For this pilot study, approximately 90 elective adult patients scheduled for gastroscopy will be recruited. Patients will be randomly allocated into 2 groups. Both groups will be fasted for solids and clear fluids as per standard guidelines (6 hours for solids and 2 hours for clear fluid) but they will then be randomized to drink 200 ml (standard drinking cup) at 90-150 minutes or 45-60 minutes prior to their procedure respectively.

Immediately post induction, gastric content is suctioned and emptied under direct vision via the gastroscope to assess for its volume and pH.

This will strengthen the body of evidence that water consumption before general anesthesia up to 45 minutes before anaesthesia has minimal effect on gastric contents and may be potentially beneficial to patients.
Trial website
Nil
Trial related presentations / publications
Nil
Public notes

Contacts
Principal investigator
Name 33826 0
Address 33826 0
Country 33826 0
Phone 33826 0
Fax 33826 0
Email 33826 0
Contact person for public queries
Name 17073 0
Lyndon Siu
Address 17073 0
Monash Medical Centre - Department of Anaesthesia
246 Clayton Road
Clayton
VIC 3168
Country 17073 0
Australia
Phone 17073 0
+61 3 95943283
Fax 17073 0
Email 17073 0
[email protected]
Contact person for scientific queries
Name 8001 0
Lyndon Siu
Address 8001 0
Monash Medical Centre - Department of Anaesthesia
246 Clayton Road
Clayton
VIC 3168
Country 8001 0
Australia
Phone 8001 0
+61 3 95943283
Fax 8001 0
Email 8001 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

Documents added automatically
No additional documents have been identified.