None listed
Conditions
Brief summary
The need for a period of fasting (not eating or drinking) before having a general anaesthetic is well known and accepted by the community. This measure is necessary to prevent patients from regurgitating and inhaling stomach contents, a phenomenon known as pulmonary aspiration. Many people find fasting an unpleasant experience with hunger, thirst and dry mouth common complaints. Some individuals find chewing gum while fasting helps with these symptoms, however, currently there is no significant medical evidence to either support or refute the safety of chewing gum in this period. Our group proposes to conduct a study in patients who are booked by their gastroenterologist for a gastroscopy (an inspection of the inside of their stomach with a telescope). We intend to randomly divide people into two groups, the first group will fast before their procedure as per the current normal instructions. The second group will also fast, but will be asked to chew gum during their period of fasting before the endoscopy. Both groups of patients will undergo their gastroscopy under a general anaesthetic. After insertion of the telescope the stomach will be inspected and then drained of any fluid by sucking it out through the suction channel of the telescope under direct vision by the gastroenterologist. It is normal for all people to a have a small volume (usually 20-30ml) of fluid in their stomach despite not eating or drinking due to swallowing saliva and the stomach producing its own secretions. The volume of the fluid sucked is then measured and recorded for each patient. The data collected during the course of the study will be collated and analysed statistically looking for any differences between the two study groups. Once completed, the results of the study will be published in the medical literature. The investigators postulate that chewing gum will make no significant difference in the amount of fluid in the stomach of a patient fasting before an operation. In fact, the action of chewing gum may actually be beneficial in stimulating the stomach to empty its normal residual volume of fluid. The information gained from this study will be valuable to all anaesthetists in streamlining pre-operative fasting guidelines for their patients to ensure safety as well as potentially improving comfort while they are fasting.
Interventions
The intervention for assessment is pre-operative use of chewing gum outside of the usually applied fasting guidelines limits. Fasting otherwise will be six hours for food and two hours for clear fluids. Participants in the intervention group will be provided with Sugar-free mint flavoured chewing gum (posted out in a participant information pack) and given both verbal and written instructions on how it may be used. Verbal information will be provided by a research assistant, by phone and accord
The intervention for assessment is pre-operative use of chewing gum outside of the usually applied fasting guidelines limits. Fasting otherwise will be six hours for food and two hours for clear fluids. Participants in the intervention group will be provided with Sugar-free mint flavoured chewing gum (posted out in a participant information pack) and given both verbal and written instructions on how it may be used. Verbal information will be provided by a research assistant, by phone and according to a scripted instruction pro-forma and at the time phone consent for participation is obtained. Written information will be included in the mailed participant pack. Instructions to participants will include to start chewing sugar-free chewing gum from the time of fasting from food. A packet of commonly used mint flavoured sugar-free gum will be sent out in the post with the study paperwork. Participants will be instructed to keep chewing gum right up until the nurses at Calvary Endoscopy to tell them to stop (when the nurses start preparing them for gastroscopy). Participants will be asked to take note of what time they start chewing the gum and how many pieces of gum are used out of the packet.
Sponsors
Gregg Best
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Prevention
Masking
Blinded (masking used) (Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Adult patients aged greater than 18 years, who after being booked for an elective gastroscopy by their treating gastroenterologist at the specialist’s rooms, will be asked to take part in the trial.
Exclusion criteria
i. Age less than 18 years ii. Patient declines to be recruited as a participant in the trial iii. Patient has a past history of upper gastrointestinal surgery including but not limited to : total or partial gastrectomy, operations involving gastroenterostomy (eg Whipples procedure), gastric lap band, laparoscopic sleeve gastrectomy, Nissen fundoplication, gastric pyeloplasty iv. Past history of achalasia, severe oesophageal stricture, oesophageal carcinoma or other swallowing disorder v. Past history of scleroderma or other disease causing gastroparesis vi. Chronic oral opioid use or other medication causing delayed gastric emptying vii. Patient deemed not competent to consent to the trial or competent to follow instructions required by the trial
Outcome results
None listed