The Effect of Carbohydrate Loading 2 Hours Before Gastroscopy on Gastric Residual Volume and Patient's Well-being Score
NCT ID: NCT05106933
Last Updated: 2021-11-12
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
78 participants
INTERVENTIONAL
2021-01-01
2021-10-20
Brief Summary
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Detailed Description
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Methodology :
Research design :- This is a single-blind randomized controlled trial. This is a stratified (diabetes mellitus, non-diabetes mellitus) with balanced randomization (1:1), placebo-controlled study Study area :- This study will be conducted in the endoscopy room, Hospital Universiti Sains Malaysia (HUSM) in Kubang Kerian, Kelantan, Malaysia
All subjected planned for OGDS with the complaint of one or more of the following symptoms : Bothersome postprandial fullness, early satiety, epigastric pain or epigastric burning and fulfill the inclusion criteria are selected. Patients will be approached and be explained regarding the study in surgical outpatient clinic before OGDS. The patient will be approached again on the day of OGDS, if agree to participate, informed consent will be obtained. Informed consent will be obtained after explanation regarding the study and procedure again by researcher nurse.
The allocation sequence is according to computer-generated random number list, it was prepared by an investigator with no clinical involvement in the trial. The allocation sequence was concealed from researcher enrolling and assessing participants. The allocation sequence will be sealed in sequentially numbered and opaque envelopes. A manila card will be placed inside envelop to render it impermeable to intense light. To prevent subversion of the allocation sequence, the name and identification number of the participants will be written on a book together with the series number on the envelope. The details in the book will be kept confidentially.
After enrolled subject complete all the baseline assessment, the corresponding envelope will be enclosed by the trained staff (who not involved in the study) who prepare the drink. The staff need to ensure that the envelop is still sealed when receiving it. The staff will prepare the drink into an identical container according to the assignment.
The subjects are randomized into 2 groups: 1 group with 400mL plain water and another group given 1 packet carborie (400mL). Subjects need to finish the drink over 10 minutes. After that, subjects are not allowed to leave endoscope room until finish OGDS to prevent consumption of other drink or food.
2 hours after that, the subject undergoes OGDS. OGDS is performed following the standard protocol.
1. The patient lies in the left lateral position
2. Medication/lignocaine spray to numb the back of throats (spray) will be given to prevent gagging during the passage of the instrument
3. A plastic mouth guard (mouthpiece) is placed between the teeth to prevent damage to the teeth and endoscope
4. The endoscope (also called a gastroscope) will be inserted through the mouthpiece
5. A small container or yankauer suction is placed close to the mouth of a patient to collect saliva during and after the oesophagogastroduodenoscopy (OGDS)
6. The endoscope will be inserted along the middle line of the soft palate
7. Once endoscope advanced, the patient may be asked to swallow to facilitate advancement of scope
8. Throughout the procedure, no water flushing is allowed, only air inflation is allowed.
Visualized pooling of fluid in the stomach is aspirated until dry via direct visualization with the endoscope. The aspirated fluid will be collected in the suction reservoir and the fluid will be measured
Subject's well-being score is assessed via visual analogue scale (VAS) which consist of 5 parameters: hunger, thirst, anxiety, tiredness and general discomfort. This scale will be used repeatedly during this study to assess the patient's well-being. The trained staff nurse will ask the patient regarding the level of 5 parameters and subject need to mark \[X\] somewhere along the horizontal line given before drink and before OGDS procedure.
All subjects are advised to inform assessor if there is an adverse reaction. Medical personnel are available to manage any adverse events that might occur throughout the procedure.
The possible risk that may arise in the study includes injury to the gastrointestinal wall, aspiration and bleeding which is the similar risk for all patient undergoing for OGDS procedure. The small volume of the drink will not cause psychological distress to the subject, but its taste may not be palatable.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Plain water
Group A patient will be given 400cc of plain water, 2 hours prior to gastroscopy
Plain water
Measure gastric residual volume during upper endoscopic, after given plain water and carborie 2 hours prior upper endoscopy
Carborie
Group B patient will be given 400cc of carborie (carbohydrate drink), 2 hours prior to gastroscopy
Carborie
carbohydrate drink
Interventions
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Plain water
Measure gastric residual volume during upper endoscopic, after given plain water and carborie 2 hours prior upper endoscopy
Carborie
carbohydrate drink
Eligibility Criteria
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Inclusion Criteria
* Agree to participate
Exclusion Criteria
* 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
18 Years
ALL
Yes
Sponsors
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Hospital Universiti Sains Malaysia
OTHER
Responsible Party
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MOHD FIRDAUS BIN ZULKIFLI
Dr. Mohd Firdaus bin Zulkifli
Principal Investigators
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Nizam Hashim, Master
Role: STUDY_DIRECTOR
HUSM, Kubang Kerian, Malaysia
Locations
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Department of General Surgery
Kota Bharu, Kelantan, Malaysia
Countries
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References
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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.
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.
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.
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.
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.
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.
Other Identifiers
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HUSM Malaysia
Identifier Type: -
Identifier Source: org_study_id