The Effect of Carbohydrate Loading 2 Hours Before Gastroscopy on Gastric Residual Volume and Patient's Well-being Score

NCT05106933 | Completed DMC

• 1 other identifier: HUSM Malaysia
• Study Type: interventional
• Target: 78
• Locations: 1 country
• Sites: 1

Brief Summary

This is a single-blind randomized controlled trial with a stratified (diabetes mellitus, non-diabetes mellitus), balanced randomization (1:1), placebo-controlled study regarding the effect of carbohydrate loading 2 hours prior to the outpatient upper endoscopic procedure. All patients who were assigned for outpatient oesophagogastroduodenoscopy (OGDS) were invited to join in this study voluntarily from January 2021 until August 2021. This study was conducted in the Endoscopy Unit, Hospital Universiti Sains Malaysia, Kubang Kerian, Malaysia. The endoscopists that performed this procedure were blinded and there was trained staff who was not involved in the study to assess the well-being score. The study protocol had been approved by the Human Research Ethics Committee of Universiti Sains Malaysia (JEPeM) with the assigned protocol code USM/JEPeM/20080414.

Conditions

Gastric Residual Volume; Upper Endoscopy

Keywords

GRV

Outcome Measures

Primary Outcomes (1)

• To compare the gastric residual volume 2 hours after carbohydrate loading (intervention group) and plain water group (control group)

  Patients will be randomised into control group and intervention group. Those in intervention group will have to drink clear water containing carbohydrate (carborie) 2 hours prior to gastroscopy. Endoscopist will measure patient's gastric residual volume. Residual gastric fluid will be aspirated into the container, final volume will be measured.

  2 hour before OGDS

Secondary Outcomes (1)

• To compare the patient's well-being after ingestion of carbohydrate loading (intervention group) and plain water (control group)

  2 hours

Other Outcomes (1)

• To assess the effect of carbohydrate loading in patient planned for OGDS in HUSM

  2 hours prior OGDS

Study Arms (2)

Plain water

PLACEBO COMPARATOR

Group A patient will be given 400cc of plain water, 2 hours prior to gastroscopy

Other: Plain water

Carborie

EXPERIMENTAL

Group B patient will be given 400cc of carborie (carbohydrate drink), 2 hours prior to gastroscopy

Other: Carborie

Interventions

Plain water OTHER

Measure gastric residual volume during upper endoscopic, after given plain water and carborie 2 hours prior upper endoscopy

Plain water

Carborie OTHER

carbohydrate drink

Carborie

Eligibility Criteria

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

You may qualify if:

• Patient 18 years old and above
• Agree to participate

You may not qualify if:

• History of upper gastrointestinal surgery
• Patient with active gastrointestinal bleeding
• Unstable clinical condition
• Mentally disable or who cannot give an informed consent
• Patient on the nasogastric feeding tube
• Pregnant patient
• American Society of Anesthesiologists classification of physical status grade 3 or above
• Insulin dependent Diabetes Mellitus more than 10 years
• Patient who is carbohydrate intolerance

Sponsors & Collaborators

• Hospital Universiti Sains Malaysia: lead

Study Sites (1)

Department of General Surgery

Kota Bharu, Kelantan, 15200, Malaysia

Location

Related Publications (6)

• Qureshi WA, Zuckerman MJ, Adler DG, Davila RE, Egan JV, Gan SI, Lichtenstein DR, Rajan E, Shen B, Fanelli RD, Van Guilder T, Baron TH; Standards of Practice Committee, American Society for Gastrointestinal Endoscopy. ASGE guideline: modifications in endoscopic practice for the elderly. Gastrointest Endosc. 2006 Apr;63(4):566-9. doi: 10.1016/j.gie.2006.02.001. No abstract available.

  PMID: 16564853 RESULT

• De Silva AP, Amarasiri L, Liyanage MN, Kottachchi D, Dassanayake AS, de Silva HJ. One-hour fast for water and six-hour fast for solids prior to endoscopy provides good endoscopic vision and results in minimum patient discomfort. J Gastroenterol Hepatol. 2009 Jun;24(6):1095-7. doi: 10.1111/j.1440-1746.2009.05782.x. Epub 2009 Feb 12.

  PMID: 19220672 RESULT

• Sabry R, Hasanin A, Refaat S, Abdel Raouf S, Abdallah AS, Helmy N. Evaluation of gastric residual volume in fasting diabetic patients using gastric ultrasound. Acta Anaesthesiol Scand. 2019 May;63(5):615-619. doi: 10.1111/aas.13315. Epub 2019 Jan 4.

  PMID: 30609007 RESULT

• Spada C, McNamara D, Despott EJ, Adler S, Cash BD, Fernandez-Urien I, Ivekovic H, Keuchel M, McAlindon M, Saurin JC, Panter S, Bellisario C, Minozzi S, Senore C, Bennett C, Bretthauer M, Dinis-Ribeiro M, Domagk D, Hassan C, Kaminski MF, Rees CJ, Valori R, Bisschops R, Rutter MD. Performance measures for small-bowel endoscopy: A European Society of Gastrointestinal Endoscopy (ESGE) Quality Improvement Initiative. United European Gastroenterol J. 2019 Jun;7(5):614-641. doi: 10.1177/2050640619850365. Epub 2019 May 15.

  PMID: 31210941 RESULT

• American Society of Anesthesiologists Committee. 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 Committee on Standards and Practice Parameters. Anesthesiology. 2011 Mar;114(3):495-511. doi: 10.1097/ALN.0b013e3181fcbfd9. No abstract available.

  PMID: 21307770 RESULT

• Zulkifli MF, Md Hashim MN, Zahari Z, Wong MP, Syed Abd Aziz SH, Yahya MM, Wan Zain WZ, Zakaria AD, Ramely R, Jien Yen S, Othman MF. The effect of pre-endoscopy maltodextrin beverage on gastric residual volume and patient's well-being: a randomised controlled trial. Sci Rep. 2023 Nov 16;13(1):20078. doi: 10.1038/s41598-023-47357-5.

  PMID: 37973795 DERIVED

Study Officials

• Nizam Hashim, Master

  HUSM, Kubang Kerian, Malaysia

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr. Mohd Firdaus bin Zulkifli

Model Details: Carbohydrate loading vs Clear water

Study Record Dates

• First Submitted: October 9, 2021
• First Posted: November 4, 2021
• Study Start: January 1, 2021
• Primary Completion: August 31, 2021
• Study Completion: October 20, 2021
• Last Updated: November 12, 2021

Record last verified: 2021-11

Data Sharing

• IPD Sharing: Will not share

Locations

MY (1)