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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

300 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-04-04

Study Completion Date

2023-11-30

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.

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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.

Conditions

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Hunger Depression Anxiety Vomiting Abdominal Pain Thirst Fatigue Lethargy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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.

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Outcome Assessors

Endoscopists will be blinded to the patients' assigned arm.

Study Groups

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Fasting Arm

Patient will fast at least 6 hours prior to endoscopy

Group Type NO_INTERVENTION

No interventions assigned to this group

Water Arm

Patient will drink 400 ml of water 2 to 4 hours prior to endoscopy

Group Type ACTIVE_COMPARATOR

Water

Intervention Type OTHER

400ml of water to be consumed 2 to 4 hours prior to the endoscopy.

CHO Arm

Patient will drink 400 ml of Preload 2 to 4 hours prior to endoscopy

Group Type EXPERIMENTAL

Nestle Preload

Intervention Type OTHER

1 sachet of Preload (50g) diluted with 400ml of water, to be consumed 2 to 4 hours prior to the endoscopy.

Interventions

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Nestle Preload

1 sachet of Preload (50g) diluted with 400ml of water, to be consumed 2 to 4 hours prior to the endoscopy.

Intervention Type OTHER

Water

400ml of water to be consumed 2 to 4 hours prior to the endoscopy.

Intervention Type OTHER

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

Minimum Eligible Age

21 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes