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Completed

NCT Number: NCT05342116

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

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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Key information

Conditions

Hunger Abdominal Pain Anxiety Anxiety Disorders Behavior Behavioral Symptoms Depression Fatigue Lethargy Mental Disorders Nervous System Diseases Neurobehavioral Manifestations Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms Signs and Symptoms, Digestive Thirst Vomiting

Age range

21 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Tan Tock Seng Hospital

Singapore, 308433

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Nestle Preload

Other

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

Water

Other

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

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

  2. 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.

Sponsors and collaborators

Lead sponsor

Tan Tock Seng Hospital

Other

Registry information

Important dates

Study start
2019
Primary completion
2023
Study completion
2023
First posted
Apr 22, 2022
Registry last updated
Apr 10, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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