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

NCT05342116 | Completed

• 1 other identifier: 2017/00872
• Study Type: interventional
• Target: 300
• Locations: 1 country
• Sites: 1

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.

Conditions

Hunger; Depression; Anxiety; Vomiting; Abdominal Pain; Thirst; Fatigue; Lethargy

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Evaluate if Carbohydrate rich drink (CHO) pre-endoscopy is safe for patients

  Endoscopist Questionnaire will be completed within 60 minutes post endoscopy.

• Evaluate if Carbohydrate rich drink (CHO) pre-endoscopy affects the quality of gastric preparation

  Endoscopist Questionnaire will be completed within 60 minutes post endoscopy.

Study Arms (3)

Fasting Arm

NO INTERVENTION

Patient will fast at least 6 hours prior to endoscopy

Water Arm

ACTIVE COMPARATOR

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

Other: Water

CHO Arm

EXPERIMENTAL

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

Other: Nestle Preload

Interventions

Nestle Preload OTHER

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

CHO Arm

Water OTHER

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

Water Arm

Eligibility Criteria

• Age: 21 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Planned for elective gastroscopy.
• Able to communicate to give informed consent and complete the questionnaire
• to 80 year old
• ASA physical status I-II

You may not qualify if:

• 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

Sponsors & Collaborators

• Tan Tock Seng Hospital: lead

Study Sites (1)

Tan Tock Seng Hospital

Singapore, 308433, Singapore

Location

Related Publications (5)

• Gustafsson UO, Hausel J, Thorell A, Ljungqvist O, Soop M, Nygren J; Enhanced Recovery After Surgery Study Group. Adherence to the enhanced recovery after surgery protocol and outcomes after colorectal cancer surgery. Arch Surg. 2011 May;146(5):571-7. doi: 10.1001/archsurg.2010.309. Epub 2011 Jan 17.

  PMID: 21242424 BACKGROUND

• Hausel J, Nygren J, Lagerkranser M, Hellstrom PM, Hammarqvist F, Almstrom C, Lindh A, Thorell A, Ljungqvist O. A carbohydrate-rich drink reduces preoperative discomfort in elective surgery patients. Anesth Analg. 2001 Nov;93(5):1344-50. doi: 10.1097/00000539-200111000-00063.

  PMID: 11682427 BACKGROUND

• Practice Guidelines for Preoperative Fasting and the Use of Pharmacologic Agents to Reduce the Risk of Pulmonary Aspiration: Application to Healthy Patients Undergoing Elective Procedures: An Updated Report by the American Society of Anesthesiologists Task Force on Preoperative Fasting and the Use of Pharmacologic Agents to Reduce the Risk of Pulmonary Aspiration. Anesthesiology. 2017 Mar;126(3):376-393. doi: 10.1097/ALN.0000000000001452. No abstract available.

  PMID: 28045707 BACKGROUND

• Brady M, Kinn S, Stuart P. Preoperative fasting for adults to prevent perioperative complications. Cochrane Database Syst Rev. 2003;(4):CD004423. doi: 10.1002/14651858.CD004423.

  PMID: 14584013 BACKGROUND

• Nygren J, Thorell A, Jacobsson H, Larsson S, Schnell PO, Hylen L, Ljungqvist O. Preoperative gastric emptying. Effects of anxiety and oral carbohydrate administration. Ann Surg. 1995 Dec;222(6):728-34. doi: 10.1097/00000658-199512000-00006.

  PMID: 8526579 BACKGROUND

MeSH Terms

Conditions

Depression; Anxiety Disorders; Vomiting; Abdominal Pain; Fatigue; Lethargy

Interventions

Water

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior; Mental Disorders; Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Neurobehavioral Manifestations; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Hydroxides; Alkalies; Inorganic Chemicals; Anions; Ions; Electrolytes; Oxides; Oxygen Compounds

Study Officials

• Doris Ng, MBBS

  Tan Tock Seng Hospital

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Endoscopists will be blinded to the patients' assigned arm.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Consultant

Model Details: 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.

Study Record Dates

• First Submitted: April 11, 2022
• First Posted: April 22, 2022
• Study Start: April 4, 2019
• Primary Completion: November 30, 2023
• Study Completion: November 30, 2023
• Last Updated: April 10, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

SG (1)