Clinical trial NCT05342116: Carbohydrate Rich Drink Reduces Pre-endoscopic Discomfort for Patients Going for Elective Endoscopic Procedures
Official title: Carbohydrate Rich Drink Reduces Pre-endoscopic Discomfort for Patients Going for Elective Endoscopic Procedures
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hunger
Depression
Anxiety
Vomiting
Abdominal Pain
Thirst
Fatigue
Lethargy
Lead sponsor: Tan Tock Seng Hospital
Sponsor class: OTHER
First posted: 2022-04-22
Enrollment: 300
Sex: ALL
Minimum age (years): 21
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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 purpose: PREVENTION

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.

Eligibility criteria: 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

Primary outcomes:
measure: Evaluate if Carbohydrate rich drink (CHO) pre-endoscopy improves patients' overall satisfaction.
timeFrame: Questionnaire to be completed 30 to 60 minutes before endoscopy.
Secondary outcomes:
measure: Evaluate if Carbohydrate rich drink (CHO) pre-endoscopy is safe for patients
timeFrame: Endoscopist Questionnaire will be completed within 60 minutes post endoscopy.
measure: Evaluate if Carbohydrate rich drink (CHO) pre-endoscopy affects the quality of gastric preparation
timeFrame: Endoscopist Questionnaire will be completed within 60 minutes post endoscopy.
Other outcomes:
Locations:
city: Singapore
country: Singapore
facility: Tan Tock Seng Hospital
Study officials:
affiliation: Tan Tock Seng Hospital
name: Doris Ng, MBBS
role: STUDY_DIRECTOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.