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

April 8, 2024 updated by: Ng Wee Khoon, Tan Tock Seng Hospital
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

300

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Singapore
      • Singapore, Singapore, 308433
        • Tan Tock Seng Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

21 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Evaluate if Carbohydrate rich drink (CHO) pre-endoscopy improves patients' overall satisfaction.
Time Frame: 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.
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
Time Frame: 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.
Endoscopist Questionnaire will be completed within 60 minutes post endoscopy.
Evaluate if Carbohydrate rich drink (CHO) pre-endoscopy affects the quality of gastric preparation
Time Frame: 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.
Endoscopist Questionnaire will be completed within 60 minutes post endoscopy.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Tan Tock Seng Hospital

Investigators

  • Study Director: Doris Ng, MBBS, Tan Tock Seng Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 4, 2019

Primary Completion (Actual)

November 30, 2023

Study Completion (Actual)

November 30, 2023

Study Registration Dates

First Submitted

April 11, 2022

First Submitted That Met QC Criteria

April 18, 2022

First Posted (Actual)

April 22, 2022

Study Record Updates

Last Update Posted (Actual)

April 10, 2024

Last Update Submitted That Met QC Criteria

April 8, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2017/00872

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

With the initial pilot study results, we intend to expand it to other endoscopic procedures.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Subscribe