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

Not Applicable

Completed

• Conditions: Abdominal Pain; Hunger; Lethargy; Thirst; Fatigue; Depression; Anxiety; Vomiting
• Interventions: Other: Nestle Preload; Other: Water

• Registration Number: NCT05342116
• Lead Sponsor: Tan Tock Seng Hospital

Brief Summary

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

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.

Study Timeline

• Study Start: 2019-04-04
• Study First Submitted: 2022-04-11
• Study First Submitted QC: 2022-04-18
• Study First Posted: 2022-04-22
• Primary Completion: 2023-11-30
• Study Completion: 2023-11-30
• Status Verified: 2024-04
• Last Update Submitted: 2024-04-08
• Last Update Posted: 2024-04-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 300

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
CHO Arm	Nestle Preload	Patient will drink 400 ml of Preload 2 to 4 hours prior to endoscopy
Water Arm	Water	Patient will drink 400 ml of water 2 to 4 hours prior to endoscopy

Primary Outcome Measures

Name	Time	Method
Evaluate if Carbohydrate rich drink (CHO) pre-endoscopy improves patients' overall satisfaction.	Questionnaire to be completed 30 to 60 minutes before endoscopy.	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.

Secondary Outcome Measures

Name	Time	Method
Evaluate if Carbohydrate rich drink (CHO) pre-endoscopy is safe for patients	Endoscopist Questionnaire will be completed within 60 minutes post endoscopy.	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.
Evaluate if Carbohydrate rich drink (CHO) pre-endoscopy affects the quality of gastric preparation	Endoscopist Questionnaire will be completed within 60 minutes post endoscopy.	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.

Trial Locations

Locations (1)

Tan Tock Seng Hospital; 🇸🇬 Singapore, Singapore