Gastric Emptying Clinical Trial
— GETEAMOfficial title:
Gastric Emptying of Tea With Milk, Compared With Tea Without Milk. Does Milk Delay Gastric Emptying?
Most pre-operative fasting regimes dictate that if there is any milk added to tea or coffee, the preoperative fasting time should be extended from 2 to 6 hours. The purpose of this study is to demonstrate whether there is really a delay in gastric emptying time associated with the inclusion of milk in a cup of tea.
Status | Completed |
Enrollment | 10 |
Est. completion date | March 2012 |
Est. primary completion date | January 2012 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Both |
Age group | 18 Years to 40 Years |
Eligibility |
Inclusion Criteria: - Healthy non-pregnant volunteers Exclusion Criteria: - medical conditions with a predisposition to delayed gastric emptying (e.g. diabetes or gastric disease) - ingestion of paracetamol within the previous 24 hours - ingestion of solids or non-clear liquids in the previous six hours - ingestion of clear liquids in the previous two hours. |
Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Single Blind (Investigator), Primary Purpose: Basic Science
Country | Name | City | State |
---|---|---|---|
United Kingdom | St Thomas' Hospital | London |
Lead Sponsor | Collaborator |
---|---|
Guy's and St Thomas' NHS Foundation Trust |
United Kingdom,
Darwiche G, Almér LO, Björgell O, Cederholm C, Nilsson P. Measurement of gastric emptying by standardized real-time ultrasonography in healthy subjects and diabetic patients. J Ultrasound Med. 1999 Oct;18(10):673-82. — View Citation
Smith I, Kranke P, Murat I, Smith A, O'Sullivan G, Søreide E, Spies C, in't Veld B; European Society of Anaesthesiology. Perioperative fasting in adults and children: guidelines from the European Society of Anaesthesiology. Eur J Anaesthesiol. 2011 Aug;28(8):556-69. doi: 10.1097/EJA.0b013e3283495ba1. Review. — View Citation
Wong CA, Loffredi M, Ganchiff JN, Zhao J, Wang Z, Avram MJ. Gastric emptying of water in term pregnancy. Anesthesiology. 2002 Jun;96(6):1395-400. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Tmax | tmax = the time taken to reach peak paracetamol concentration. The blood samples were analysed for the level of paracetamol, from which the time taken to reach peak paracetamol concentration was subsequently calculated. Blood samples were taken at the same time points as the ultrasound measurements. | Blood samples taken every 10 minutes for 1 hour and then 30 minute intervals until 150 minutes had elapsed. Each participant spent approximately 3 hours for each arm of the trial separated by no less than 24 hours | No |
Secondary | T½ | T½ = time from baseline to the time the cross-sectional surface area (CSA) of the gastric antrum, measured using realtime ultrasound, returned to half the maximal value (CSA½max ). CSA ½ max calculated as below: CSA½max = CSAmax - [(CSAmax - CSAbaseline)/2] |
Measurments taken every 10 minutes for 1 hour and then 30 minute intervals until 150 minutes had elapsed. Each participant spent approximately 3 hours for each arm of the trial separated by no less than 24 hours. | No |
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