Carbohydrate Rich Drink Reduces Pre-endoscopic Discomfort for Patients Going for Elective Endoscopic Procedures

Study Overview
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Brief Summary
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The study is a randomised controlled trial that aims to evaluate whether carbohydrate loading pre-endoscopy can improve patients' overall satisfaction and is not associated with negative impact on endoscopic quality or increased complications. A questionnaire will be completed by participants prior to endoscopy.

Detailed Description
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Currently, the evidence of usage of CHO is mainly for pre-operative patients and has never been evaluated for use in patients before endoscopic procedures which would also require them to fast substantially. Using the same principles of perioperative care, the aim of this a pilot study is to evaluate if Preload usage prior to endoscopic procedures will minimise patient discomfort secondary to fasting with alleviation of preprocedural thirst, hunger and anxiety symptoms. As a result, it may also reduce the urge for patients to drink and ingest prior to endoscopy, which may translate to last minute cancellation of procedures and wastage of precious resources. We believe it will improve overall patient experience and compliance to preprocedural fasting, without significant risks for patients or affecting the quality of endoscopy.

Official Title
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Carbohydrate Rich Drink Reduces Pre-endoscopic Discomfort for Patients Going for Elective Endoscopic Procedures

Conditions
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Depression, Anxiety, Hunger, Vomiting, Abdominal Pain, Thirst, Fatigue, Lethargy

Intervention / Treatment
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* Other: Nestle Preload
* Other: Water


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Planned for elective gastroscopy. Able to communicate to give informed consent and complete the questionnaire 21 to 80 year old ASA physical status I-II Exclusion Criteria: Medications that might impair gastrointestinal motility Conditions that may impair gastrointestinal motility, gastroesophageal reflux, pregnancy Potential for difficult airway management. Diabetic patients. American Society of Anesthesiology (ASA) physical status III or more Unable to communicate to give informed consent or complete the questionnaire

Ages Eligible for Study
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Minimum Age: 21 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: A randomised controlled trial with 3 arms: (1) Fasting 6 hours prior to endoscopy, (2) Allow up to 400ml of water up to 2 hours before endoscopy, (3) Carbohydrate loading with Preload 400ml at least 2-4 hours before endoscopy.
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Fasting Arm<br>Patient will fast at least 6 hours prior to endoscopy | |
| Active Comparator: Water Arm<br>Patient will drink 400 ml of water 2 to 4 hours prior to endoscopy | Other: Water<br>* 400ml of water to be consumed 2 to 4 hours prior to the endoscopy.<br>|
| Experimental: CHO Arm<br>Patient will drink 400 ml of Preload 2 to 4 hours prior to endoscopy | Other: Nestle Preload<br>* 1 sachet of Preload (50g) diluted with 400ml of water, to be consumed 2 to 4 hours prior to the endoscopy.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluate if Carbohydrate rich drink (CHO) pre-endoscopy improves patients' overall satisfaction. | To evaluate if Carbohydrate rich drink pre-endoscopy helps to reduce discomfort experienced by patients during fasting, with lesser thirst, hunger, pain and anxiety, resulting in better overall satisfaction for endoscopic procedures. Participants will be asked to complete a Satisfaction Questionnaire prior to the endoscopy. | Questionnaire to be completed 30 to 60 minutes before endoscopy. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluate if Carbohydrate rich drink (CHO) pre-endoscopy is safe for patients | Most endoscopy centres require patients to fast for 6 to 8 hours prior to endoscopy (fasting arm) or may allow clear fluids up till 2 hours prior to endoscopy (water arm). We aim to evaluate if Carbohydrate rich drink (CHO) has the same safety profile (in terms of risk of aspiration pneumonia and patient discomfort), compared to the conventional fasting arm and water arm. Endoscopist performing the gastroscopy will complete an Endoscopist Questionnaire, which will record if there were any periprocedural complications. | Endoscopist Questionnaire will be completed within 60 minutes post endoscopy. | 
| Evaluate if Carbohydrate rich drink (CHO) pre-endoscopy affects the quality of gastric preparation | Most endoscopy centres require patients to fast for 6 to 8 hours prior to endoscopy (fasting arm) or may allow clear fluids up till 2 hours prior to endoscopy (water arm). We aim to evaluate if Carbohydrate rich drink (CHO) affects the quality of gastric preparation (in terms of good endoscopic views during gastroscopy), compared to the conventional fasting arm and water arm. Endoscopist performing the gastroscopy will complete an Endoscopist Questionnaire, which will record if there were good endoscopic views during the gastroscopy. | Endoscopist Questionnaire will be completed within 60 minutes post endoscopy. |