The Effect of Carbohydrate Loading on Gastric Residual Volume and Hunger Score: A Single Blind, Randomised Controlled Trial Study
Phase: NA
Conditions: Gastric Residual Volume
Sponsor: Universiti Sains Malaysia

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The effect of carbohydrate loading on 
gastric residual volume and hunger score:  
A single blind, randomised controlled 
trial study 
 
Dr Lua Bee Chen 
P-UM 0100/17 
 
Department of Surgery 
Health Campus University Science Malaysia (USM) 
 
Supervisor: 
Dr Michael Wong Pak Kai 
 
Co-supervisor: 
Dr Mohd Nizam Bin Md Hashim  
 
 
Date of document: 15th April 2019 

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The effect of carbohydrate loading on gastric residual volume and hunger 
score 
 
Introduction 
 
ERAS (enhanced recovery after surgery) protocol is a standardised perioperative care procedure which 
aim to improve patient outcome(Carmichael et al., 2017). It can be divided into preoperative, 
intraoperative and postoperative components. One of the measures in preoperative care component 
is carbohydrate loading. Carbohydrate loading is usage of carbohydrate rich beverage prior to 
operation to improve insulin resistance post operation(Faria et al., 2009). Body response to surgery 
and prolong fasting by releasing of stress hormone and inflammatory marker(Kratzing, 2011). This led 
to insulin resistance and catabolic state(Kratzing, 2011). Production of glucose via gluconeogenesis 
and inability of usage of glucose by peripheral tissues due to insulin resistance cause hyperglycaemia 
post operation(Kratzing, 2011). This catabolic state and insulin resistance are associated with 
increased morbidity and mortality postoperatively(Gustafsson et al., 202308; Tran et al., 2013). By 
giving carbohydrate loading prior operation shift body metabolic from fasted state into fed state(Tran 
et al., 2013). 
 
Recent guideline had recommended to allow solid food until 6 hours prior to and clear fluid 2 hours 
prior to operation in replace to fasting of minimum of 6 hours(Kratzing, 2011). However, most of the 
centres still practice nil by mouth for minimum of 6 hours due to worried of pulmonary aspiration. 
According to previous study, patient are at risk of develop pulmonary aspiration if the gastric 
content >25ml (>0.4ml/kg) and the pH<2.5(Dalal et al., 2010). Pulmonary aspiration is a fatal 
complication for patient undergoes general anaesthesia. It is due to aspiration of acidic gastric content 
during intubation and subsequently leads to pneumonitis(Nason, 2015). There are several normal 
physiological reflex mechanism to prevent aspiration of gastric content but they were abolished by 

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the drugs used during general anaesthesia(Robinson and Davidson, 2014). Apart from residual gastric 
volume and pH, delay gastric emptying in patient who has diabetic mellitus, dyspepsia, history upper 
gastrointestinal surgery or intestinal obstruction can predispose to pulmonary aspiration also(Asai, 
2004). 
 
According to study, amount of carbohydrate that can stimulate insulin release is 50g(Kratzing, 2011). 
Carbohydrate rich beverage contained polymer (maltodextrin) is used as carbohydrate loading 
currently because its low osmolality compared with other monomer beverage(Nygren et al., 1995). 
Low osmolality leads to increase gastric emptying rate(Nygren et al., 1995). However, absorption of 
small bowel for glucose from digested maltodextrin is rapid, which affect blood sugar level especially 
in diabetic patient(Hofman et al., 2016).  
 
There is still no proper guideline regarding usage of carbohydrate loading in diabetic mellitus patient 
prior to operation in view of possibility of delay gastric emptying and poor glycaemic control after 
loading(Gustafsson et al., 2008).  
 
Other than metabolic effect, carbohydrate loading also improve patient’s wellbeing in the aspect of 
thirst, hunger and anxiety in most of the study(Gustafsson et al., 2008; Hausel et al., 2001).  
 
Most studies conducted showed carbohydrate loading prior to operation is safe and benefit. However, 
most of studies conducted to measure gastric volume is through aspiration via nasogastric tube. This 
study conducted is to assess effect of carbohydrate loading (maltodextrin with whey protein) to gastric 
volume 2 hours after ingestion via aspiration while doing OGDS (direct visualisation) and patient’s 
wellbeing (hunger, thirst, weakness, tiredness, anxiety) for all patient planned for OGDS. 
 
 

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Literature review 
 
Enhanced recovery after surgery (ERAS) protocol is also known as fast track protocol. It is an evidence-
based protocol with multimodal perioperative care pathway(Carmichael et al., 2017). It is designed to 
improve patient outcome after treatment and care. There are several standardised practices can be 
done preoperatively, intraoperatively and postoperatively in order to achieve pain free postoperation, 
return bowel function in shorter time, improve wound healing and shorten hospitalisation(Carmichael 
et al., 2017; Noblett et al., 2006). With the ERAS protocol developed, overall complication rate and 
length of hospitalisation reduced as compared to conventional practice(Adamina et al., 2011). 
Patient’s satisfication is also improved and cost of hospitalisation is reduced(Carmichael et al., 2017; 
Kratzing, 2011). Apart from surgeon, cardio-thoracic surgeon or gynaecologist also practice according 
to this protocol(Kaska et al., 2010). 
 
Body response towards injury or surgical trauma can be divided into ebb and flow phase(Faria et al., 
2009). Ebb phase is response of body in order to maintain hemodynamic stability. After ebb phase, 
body enter flow phase, where catabolic state started. This response is mediated by stress hormone 
and release of cytokines(Kratzing, 2011). Stress hormones and cytokines cause consumption of 
glycogen reservoir, increase gluconeogenesis and insulin resistance of peripheral tissues(Faria et al., 
2009). All of these contribute to hyperglycaemic after injury.  Peripheral insulin resistance also leads 
to proteolysis, inability to utilise glucose as source of energy and subsequently reduced muscle 
function(Kratzing, 2011). All of these happened even after minor operation(Helminen et al., 2009) and 
the condition worsen if added prolonged fasting(Faria et al., 2009; Weledji et al., 2017). 
Hyperglycaemia and insulin resistance are associated with post operation complication. Intensive 
insulin therapy had shown to give a better outcome(Kratzing, 2011).  
 

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Carbohydrate loading is recommended as preoperation measure in ERAS protocol because it induce 
insulin release and shift body metabolism from fasting to feed state(Tran et al., 2013). Previous study 
showed that 50g of carbohydrate is needed to produce this effect. Hence, carbohydrate loading with 
100g carbohydrate on the night before operation and 50g of carbohydrate 2 hours prior operation 
were used (Kratzing, 2011).  
 
Traditionally, adequate fasting time with a minimum of 6 hours is required before operation in order 
to prevent pulmonary aspiration during general anaesthesia. Lately, allow clear fluid for up to 2 hours 
prior operation is recommended as it improve patient’s wellbeing and it is safe(Kratzing, 2011). 
However, not all solution is safe to be used as carbohydrate loading. Type of food (solid or fluid), the 
volume of fluid, particle size and composition of the fluid can affect gastric emptying rate (Dalal et al., 
2010; Nygren et al., 1995). With the presence of carbohydrate and protein, gastric emptying rate is 
shorter than fluid contain fat or cellulose(Dalal et al., 2010). Polymer carbohydrate such as 
maltodextrin has low osmolality which cause rapidly passage of fluid through stomach if compare with 
monomer fluid(Nygren et al., 1995). According to previous study, 400cc of carbohydrate rich solution 
(12.0% carbohydrate, maltodextrin) was used and it took about 90minutes to pass through stomach 
(Nygren et al., 1995). Hence, carbohydrate loading with polymer is recommended in order to provide 
large dose of carbohydrate which able to stimulate insulin release and not produce significant gastric 
residual volume prior to anaesthesia.  
 
Kaska et al. (2010) conducted a randomized, prospective and blinded clinical trial, in which patients 
were randomized into three groups: overnight fasting group as control group, intravenous administer 
glucose preoperatively and preoperative oral consumption of 400cc a specifically composed solution 
(principally maltodextrin and electrolytes). Gastric residual volume was examined by aspiration of 
juice with the aid of a gastric tube inserted temporarily at the beginning of surgery. It showed that the 
residual volume was 5 ml in all groups without statistically significant differences. However, the values 

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of gastric residual volume perioperatively was smallest in preoperative carbohydrate drink group. 
Yagci et al. (2008) had conducted similar study, in which patient was randomized into 2 groups that 
were overnight fasting and carbohydrate drink(800cc on the evening before and 400cc 2 hours prior 
to operation), it showed no statistically significant difference between two groups with respect to 
gastric residue contents. Itou et al. (2011) conducted a study which randomized patient into 2 group 
that were fasting group and ORS group showed similar result. However, study conducted by Dalal et 
al. (2010) randomized patient into 2 groups that were fasting (group I) and water (group II). It showed 
that the gastric fluid volume was found to be lesser in Group II (5.5 ± 3.70 ml) than Group I (17.1 ± 8.2 
ml) which was statistically significant. 
 
Significant gastric residual volume can predispose to pulmonary aspiration for patient undergo general 
anaesthesia. Pulmonary aspiration is defined of inhalation of solid or liquid into respiratory 
tract(Nason, 2015). It occurs 1 in 900 to 1 in 10000 of patient underwent general 
anaesthesia(Robinson and Davidson, 2014). General anaesthesia is considered safe in most of the 
cases, but pulmonary aspiration can cause significant airway related mortality and morbidity(Nason, 
2015). Entry of acidic gastric content into lung leads to pneumonitis. The severity of the injury to lung 
parenchymal is depend on gastric volume, pH level of aspirated gastric content and content of the 
aspirated fluid which cause infection or mechanical airway obstruction(Nason, 2015). Traditionally, 
patient is considered as high risk of aspiration pneumonia if gastric volume aspirated more than 25cc 
and pH less than 2.5(Dalal et al., 2010). There are several normal physiological reflex mechanism 
presences in order to prevent aspiration which include gastroesophageal junction, upper oesophageal 
sphincter and protective laryngeal reflex(Robinson and Davidson, 2014). However, these protective 
reflexes abolished after general anaesthesia due to the drug used during anaesthesia. Apart from the 
causes above, systemic disease such as diabetic mellitus also affect gastric emptying time.(Asai, 2004) 
 

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In addition to metabolic effect due to carbohydrate loading, patient’s well being such as hunger, thirst, 
anxiety can be improved also(Hausel et al., 2001).  
 
Hausel et al. (2001) consucted a randomised control trial. 252 elective abdominal surgery patients 
were randomized to preparation with a 12.5% carbohydrate drink (CHO), placebo (flavored water), or 
overnight fasting. The CHO and Placebo groups were double-blinded and were given 800 mL to drink 
on the evening before and 400 mL on the morning of surgery. 11 different discomfort variables(anxiety, 
depression, hunger, inability to concentrate, malaise, nausea, pain, thirst, tiredness, unfitness, and 
weakness) were scored via Visual analog scales. During the waiting period before surgery, the CHO-
treated group was less hungry and less anxious than both the other groups (P ≤ 0.05). CHO reduced 
thirst as effectively as placebo (P < 0.0001 versus Fasted). Trend analysis showed consistently 
decreasing thirst, hunger, anxiety, malaise, and unfitness in the CHO group (P< 0.05). The Placebo 
group experienced decreasing unfitness and malaise, whereas nausea, tiredness, and inability to 
concentrate increased (P < 0.05). In the Fasted group, hunger, thirst, tiredness, weakness, and inability 
to concentrate increased (P < 0.05). 
 
Helminen et al. (2009) conducted a prospective, randomized study, in which 210 patients undergoing 
general or gastrointestinal surgery were randomly assigned to three groups: overnight intravenous 5% 
glucose infusion (1000 ml), carbohydrate-rich drink (400 ml) at 6–7 a.m., or overnight fasting. Visual 
analogue scale was used to assess the subjective feelings of thirst, hunger, mouth dryness, weakness, 
tiredness, anxiety, headache and pain preoperatively. During the waiting period before surgery, the 
carbohydrate-rich drink group was less hungry than the fasting group (P=0.011). No other differences 
were seen in visual analogue scale scores among the study groups. Trend analysis showed increasing 
thirst, mouth dryness and anxiety in the intravenous glucose group (P<0.05). The carbohydrate-rich 

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drink group experienced decreasing thirst but increasing hunger and mouth dryness (P<0.05). In the 
fasting group, thirst, hunger, mouth dryness, weakness, tiredness and anxiety increased (P<0.05). 
 
Glucose from maltodextrin is rapidly reabsorb by intestine and cause elevation of blood glucose 
rapidly(Hofman et al., 2016). It may impair blood glucose level in diabetic mellitus patient. There is a 
study about use of carbohydrate loading in diabetic mellitus patient, which showed higher peak 
glucose level which occur later and take longer time for blood glucose to return to baseline if compare 
to healthy subject(Gustafsson et al., 2008).  Because of the possibility impair blood surgar and delay 
gastric emptying in diabetic mellitus patietn, use of carbohydrate loading in diabetic mellitus paitent 
still debate. 
 
Product detail 
Resource 
Description 
Fruit flavoured beverage designed for dietary management in malnutrition and peri-operative to 
enhance outcomes and recovery. It is lactose and gluten free 
 
Age 
≥4 years old 
 
Feature 
100% high quality whey protein 
Fat free 
Clear fluid 
Low residue 
 
Indications 
carbohydrate loading for peri-operative management 
fat intolerance/ malabsorption 

9 
 
clear liquid diet 
fat free diet 
cancer with treatment 
 
Usage 
Oral/tube feeding 
 
Caloric density 
1.05kcal/ml 
 
Osmolality 
77OmOsm/kg H2O 
 
Flavour 
Fruit flavoured 
 
Nutritional information 
Per 100ml 
Per 237ml 
Energy 
105 kcal 
250 kcal 
Protein 
3.8 g 
9.0  g 
Fat-total 
0 g 
0.0  g 
Carbohydrate 
22.6 g 
53.6  g 
    - Sugars 
145 g 
34.4 g 
Dietary Fibre 
0 g 
0 g 
Sodium 
32 mg 
76 mg 
potassium 
- 
- 
phosphorous 
72 mg 
171 mg 
Calcium  
- 
- 
iron 
1.3 mg 
3.1 mg 
 
Preparation per serving 
237ml 
 
Pack size 
237ml 

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Conceptual framework  
 
 
 
 
 
 
 
 
 
 
Subject planned for OGDS in HUSM will be randomised into 2 group. Plain water is given to group1 of 
subject and carbohydrate loading is given to group 2 subjects 2 hours prior to OGDS. Residual gastric 
volume is measure through aspiration via OGDS and subject’s wellbeing are assessed for both group 
of subject prior and after clear fluid have given.  
 
Problem statement & Study rationale 
 
There are a lot of study were conducted to look for the effect of carbohydrate loading worldwide. 
However, there is limited data about used of carbohydrate and protein as carbohydrate loading. This 
study conducted by using maltodextrin with whey protein as carbohydrate loading. Method to 
measure gastric residual volume is via aspiration from direct visualisation with OGDS. This study also 
assesses effect of carbohydrate loading (polymer+ whey protein) to patient’s well being. 
All patient planned for OGDS in 
husm 
Plain water 
Carbohydrate loading  
Residual gastric volume (aspiration 
through OGDS) 
Subject’s wellbeing 
 

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Research Question(s) 
 
1. What is gastric residual volume 2 hours after carbohydrate loading group and control group? 
2. What is the effect of carbohydrate loading and control group on subject’s wellbeing? 
 
Objectives 
General: 
- 
To assess effect of carbohydrate loading in patient planned for OGDS in HUSM 
Specific: 
- 
to determine residual gastric volume 2 hours after carbohydrate loading and plain water 
group 
- 
to explore patient’s wellbeing after carbohydrate loading and control 
 
Research hypothesis 
 
First Hypothesis  
 
H1: There is significant association between carbohydrate loading with residual gastric volume 
H0: there is no significant association between carbohydrate loading with gastric residual volume 
 
Second hypothesis 
 
H1: there is significant association between carbohydrate loading with subject’s wellbeing 
H0: there is no significant association between carbohydrate loading with subject’s wellbeing 
 

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Methodology 
 
Research design 
This is a stratified (female, male) with balanced randomisation (1:1), single-blind (blind endoscopist, 
researcher enrolling and assessing participants), placebo-controlled, parallel-group study 
 
Study area 
This study will be conducted in endoscopy room in Hospital University Sains Malaysia in Kubang Kerian 
 
Operative definition 
- 
 
Study population 
Reference population: 
- 
patient who has planned for OGDS 
Source population 
- 
Patient planned for OGDS and attend endoscopy room in HUSM 
Study population 
- 
Patient planned for OGDS, attend endoscopy room for in HUSM, fulfilled inclusion criteria and 
exclusion criteria from April 2019 until December 2019 
 
Subject criteria 
Inclusion criteria 
- 
Patient more than 18 years old 
 
Exclusion criteria 

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- 
History of upper gastrointestinal surgery  
- 
Intestinal obstruction 
- 
Patient with vomiting 
- 
Mentally disable or who cannot give an informed consent 
 
End points 
Primary end point 
- 
Amount of gastric residual volume (ml) that has been aspirated via OGDS 2 hours after plain 
water or carbohydrate loading group 
Secondary end point 
- 
Score (mm) of each parameter from visual analogue scale (VAS) before drink and before OGDS 
for plain water and carbohydrate loading group 
 
Sample size estimation 
Sample size is calculated for all the objectives. However, the one that yield the biggest number is taken 
as the sample size. 
 
objective 1 is to identify the gastric residual volume between subject with plain water (group A) and 
carbohydrate loading (group B). Sample size was calculated using comparing two means formula. 
Sample size is calculate using http://www.openepi.com/SampleSize/SSMean.htm. The ratio between 
group A and group B was set as 1. According to article, standard deviation was 18.46. Means difference 
was set as 12.5.sample size for objective 1 is 35 per group. 
 
Objective 2 is to determined patient’s well being for group A and group B. sample size was calculate 
using 
comparing 
paired 
difference 
formula. 
Sample 
size 
calculate 
using 
http://statulator.com/SampleSize/ss2PM.html#.  Expected standard deviation of the paired 

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differences is set as 2 times the expected mean of the paired differences. The sample size is 34 per 
group 
 
For all sample size calculation, type I error was set at 5% (two tailed), Type 2 error was 20% (to achieve 
80% power of study). 
 
Corrected sample size is calculated after included 10% of dropout rate. Corrected sample size = 
calculated sample size/ (1-anticipated drop out rate).  
 
After considering both objective, 1st objective give biggest number of sample size. Hence, 35 subject 
per group with a total number of 70 subjects are needed to study both objectives. after consider 
dropout rate, minimum sample size in this study is 39 subjects per group with a total number of 78 
subjects.  
  
Sampling method and subject recruitment 
Patient scheduled for elective OGDS in HUSM from April 2019 to December 2019 with the complaint 
of one or more of the following symptoms: Bothersome postprandial fullness, early satiation, 
Epigastric pain or Epigastric burning are eligible to participate in the study. Patients who fulfilled 
exclusion criteria (History of upper gastrointestinal surgery, intestinal obstruction, patient with 
vomiting or mentally disable or who cannot give an informed consent) are ineligible.  
 
If a patient fulfils the inclusion criteria, a suitable medical officer will discuss the trial with patient while 
reviewing patient in surgical outpatient clinic prior to OGDS. Patient will be approached again on the 
day of OGDS, if patient agree to participate in study, a written consent will be obtained. If patient 
refuse to participate in study, appropriate treatment and care still will be provided to patient.  The 
consent form will provide information about the purpose of the study, the procedures to be followed, 

15 
 
risks and benefits of participation. If patient agree to participate in the trial, subject will be enrolled in 
the study. Method of recruitment in this study is direct recruitment of potential study participants. 
 
Stratified permuted block randomization was used. Randomization sequence was created using 
https://www.sealedenvelope.com/simple-randomiser/v1/lists and is stratified by gender (female and 
male) with 1:1 allocation. Random block sizes of 6 is used. Subjects are randomized into either 
preprocedure plain water (group A) or preprocedure carbohydrate loading group (group B). Patients 
randomized into group A consume 250ml plain water and patients in group B consume 1 packet of 
resource (237ml, 53.6g carbohydrate and 9g whey protein). Both groups of patients consume the drink 
over 10 minutes. 2 hours after that, OGDS will be carried out. 
 
Research tools 
1. Data collection pro forma 
2. Resource beverage (53.6g carbohydrate and 9g whey protein), plain water 
3. Visual analogue scale for assessment of patient well being 
- 
Each scale consisted of ungraded, horizontal lines anchored at two ends.  
- 
The left end of the scale represented “not at all” which score: 0 and the right end 
represented and “the most imaginable” which score: 100 
- 
patients mark an X somewhere along the horizontal line to complete the scale 
4. OGDS 
5. 2 Suction systems (include suction reservoir, yankauer sucker) 
 
Data collection method 
All subjected planned for OGDS with the complain of one or more of the following symptoms: 
Bothersome postprandial fullness, early satiation, Epigastric pain or Epigastric burning and fullfill 
inclusion criteria are selected. Patients will be approached and be explained regarding the study in 

16 
 
surgical outpatient clinic prior to OGDS. Patient will be approached again on the day of OGDS, if agree 
to participate, an informed consent will be obtained. Informed consent will be obtained after 
explanation regarding the study and procedure again by researcher nurse 
 
Allocation sequence is according computer generated random number list, it was prepared by an 
investigator with no clinical involvement in the trial. Allocation sequence was concealed from 
researcher enrolling and assessing participants. 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 I/C of 
the participant will be written on a book together with the series number on envelopes. The details in 
the book will be kept confidentially. After enrolled subject complete all baseline assessment, 
corresponding envelope will be enclosed by staff (who not involve in study) who prepare the drink. 
The staff need to ensure that the envelop still sealed when receive it. The staff will prepare the drink 
into identical container according to the assignment. 
 
Subjects are randomised into 2 group: 1 group with 250cc plain water and another group give 1 packet 
resource(237ml). Subjects need to finish the drink over 10minutes. After that, subjects are not allow 
to leave endoscope room before OGDS done to prevent consumption of other drink or food. 
 
2 hours after that, subject undergo OGDS. OGDS is done follow standard protocol.  
1. Patient lies in left lateral position 
2. Medication to numb the back of throats (spray) will be given to prevent gagging during the 
passage of the instrument 
3. A plastic mouth guard 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 

17 
 
5. A small container or yankauer suction is placed close to the mouth of a patient to collect saliva 
during and after the esophagogastroduodenoscopy 
6. Endoscope will be inserted along the middle line of the soft palate.  
7. Once endoscope advanced, 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 
9. visualised pooling of fluid in the stomach is aspirated until dry via direct visualization with 
endoscope. Aspirated fluid will be collected in suction reservoir and the fluid will be measured. 
 
Subject’s wellbeing is assessed via visual analogue scale (VAS) which consist of 5 parameters: hunger, 
thirst, anxiety, tiredness and weakness. This scale will be used repeatedly during this study to assess 
patient’s wellbeing. Trained staff nurse will ask patient regarding 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 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 include injury to the gastrointestinal’s wall, aspiration and 
bleeding which is the similar risk for all patient going through OGDS procedure. Small volume of the 
drink will not cause psychological distress to subject, but its taste may not be palatable. 

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Flow of study  
 
 
 
patient with dyspepsia symptoms attend endoscopy room HUSM from April 2019 to December 2019 
Fulfilled inclusion and exclusion criteria 
Block randomisation 
(block size of 6) 
Plain water 
(250ml) 
Carbohydrate loading  
(1 packet resource) 
- 
Measure gastric residual volume via aspiration with OGDS 
- 
Hunger score assessment with visual analogue scale (VAS)  
statistical analysis and report preparation 
research correction and submission of final research 
stratified by gender (male and female) 

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Data analysis 
 
The collected data will be entry and analyzed using SPSS version 24 (SPSS Inc., Chicago, IL, USA) 
 
Objective 1 is to determine and compare gastric residual volume between group A and group B 
subjects. Independent T test is used to interpret the date. 
 
Objective 2 is to determine and compare subject’s well being before and after drink in between group 
A and group B. paired t test is used to determine effect of drink on subject’s wellbeing before and 
after in each group. ANOVA is used to compare effect of the drink in both groups.   
 
 
 

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Expected result 
 
 
Assessed for eligibility (n=  ) 
Excluded (n=  ) 
 
Not meeting inclusion criteria (n=  ) 
 
Fulfilled exclusion criteria (n=  ) 
 
Decline to participate (n=  ) 
 
Other reasons (n=  ) 
Allocation to intervention (n=  ) 
 
Received allocation intervention (n=  ) 
 
Did not receive allocated intervention 
(give reasons)( n=  ) 
Allocation to intervention (n=  ) 
 
Received allocation intervention (n=  ) 
 
Did not receive allocated intervention 
(give reasons)( n=  ) 
Discontinued intervention (give reasons) (n=  ) 
Discontinued intervention (give reasons) (n=  ) 
Analysed (n=  ) 
 
Excluded from analysis (give reasons) 
(n=  ) 
Analysed (n=  ) 
 
Excluded from analysis (give reasons) 
(n=  ) 
Allocation  
Follow up 
Analysis  
Randomized (n=  ) 

21 
 
 
Patient’s characteristic 
 
Group 1 (plain water) 
(n=) 
Group 2 (resource) 
(n=) 
Age (y) 
 
 
Gender 
(female/male) 
 
 
Body mass index 
(kg/m2)  
 
 
Data presented in means (SD) or number of subject) 
 
 
Residual gastric volume in both group 
 
Group 1 (plain water) 
(n=) 
Group 2 (resource) 
(n=) 
Residual gastric volume (ml) 
 
 
Data presented in means (SD) 
 
 

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Visual analogue scale data for preprocedure discomfort variables 
VAS variable 
 
Before drink  
mm, median (IQL) 
Before OGDS 
mm, median (IQL) 
Hunger  
Group 1 
 
 
Group 2 
 
 
Thirst 
Group 1 
 
 
Group 2 
 
 
Anxiety 
Group 1 
 
 
Group 2 
 
 
Weakness  
Group 1 
 
 
Group 2 
 
 
Tiredness  
Group 1 
 
 
Group 2 
 
 
 
 
 

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Gantt chart and milestone 
 
year 
2018 
2019 
2020 
month 
J 
J 
A S O N D J 
F 
M A M J 
J 
A S O N D J 
F M A M J 
Proposal 
presentation 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Ethics 
approval 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Grant 
approval 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Data 
collection 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Data 
analysis and 
report 
presentation 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Submission 
of draft and 
revision 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Submission 
of 
final 
research 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

24 
 
Budget proposal 
Resource costs RM10 per pack. 
 
Ethical consideration  
Approval will be obtained from the Research and Ethics committee of Universiti Sains Malaysia (USM) 
and Ministry of Health before starting the study.  
 
Declaration   
There is no conflict of interest.  
 
Privacy and confidentiality  
All forms are anonymous and will be entered SPSS software. Only research team members can access 
the data, confidentially of the data will be maintained strictly. Data will be presented as grouped data 
and the participant individually or the involved patient will not be identified.  
 
Community sensitivities and benefits   
This study finding may benefit the community by knowing the effect of carbohydrate drink before 
procedure on patient’s well being and its safety to be used in future. 
 
Honorarium and incentives  
Endoscopy procedure provide to each participant with free.  
 
Subject vulnerability 
Appropriate treatment and care still will be provided to patient who refuse to participate in study. 
Patient has the right to refuse to participate in study. 
 

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Reference 
 
Adamina, M., Kehlet, H., Tomlinson, G. A., Senagore, A. J. & Delaney, C. P. (2011). Enhanced recovery 
pathways optimize health outcomes and resource utilization: A meta-analysis of randomized 
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trials 
in 
colorectal 
surgery. 
Surgery, 
149(6), 
830-840. 
doi: 
https://doi.org/10.1016/j.surg.2010.11.003 
 
Asai, T. (2004). Editorial II: Who is at increased risk of pulmonary aspiration? BJA: British Journal of 
Anaesthesia, 93(4), 497-500. doi: 10.1093/bja/aeh234 
 
Carmichael, J. C., Keller, D. S., Baldini, G., Bordeianou, L., Weiss, E., Lee, L., Boutros, M., McClane, J., 
Steele, S. R. & Feldman, L. S. (2017). Clinical practice guideline for enhanced recovery after colon and 
rectal surgery from the American Society of Colon and Rectal Surgeons (ASCRS) and Society of 
American Gastrointestinal and Endoscopic Surgeons (SAGES). Surg Endosc, 31(9), 3412-3436. doi: 
10.1007/s00464-017-5722-7 
 
Dalal, K., Rajwade, D. & Suchak, R. (2010). "Nil per oral after midnight": Is it necessary for clear fluids? 
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Faria, M. S., de Aguilar-Nascimento, J. E., Pimenta, O. S., Alvarenga, L. C., Jr., Dock-nascimento, D. B. 
& Slhessarenko, N. (2009). Preoperative Fasting of 2 Hours Minimizes Insulin Resistance and Organic 
Response to Trauma After Video-Cholecystectomy: A Randomized, Controlled, Clinical Trial. World 
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Gustafsson, U., Nygren, J., Thorell, A., Soop, M., Hellström, P., Ljungqvist, O. & HAGSTRÖM‐TOFT, E. 
(2008). Pre ‐ operative carbohydrate loading may be used in type 2 diabetes patients. Acta 
Anaesthesiologica Scandinavica, 52(7), 946-951.  
 
Hausel, J., Nygren, J., Lagerkranser, M., Hellstrom, P. M., Hammarqvist, F., Almstrom, C., Lindh, A., 
Thorell, A. & Ljungqvist, O. (2001). A carbohydrate-rich drink reduces preoperative discomfort in 
elective surgery patients. Anesth Analg, 93(5), 1344-1350.  
 
Helminen, H., Viitanen, H. & Sajanti, J. (2009). Effect of preoperative intravenous carbohydrate loading 
on preoperative discomfort in elective surgery patients. European Journal of Anaesthesiology (EJA), 
26(2), 123-127.  
 
Hofman, D. L., van Buul, V. J. & Brouns, F. J. P. H. (2016). Nutrition, Health, and Regulatory Aspects of 
Digestible Maltodextrins. Critical Reviews in Food Science and Nutrition, 56(12), 2091-2100. doi: 
10.1080/10408398.2014.940415 
 
Kaska, M., Grosmanova, T., Havel, E., Hyspler, R., Petrova, Z., Brtko, M., Bares, P., Bares, D., 
Schusterova, B., Pyszkova, L., Tosnerova, V. & Sluka, M. (2010). The impact and safety of preoperative 
oral or intravenous carbohydrate administration versus fasting in colorectal surgery--a randomized 
controlled trial. Wien Klin Wochenschr, 122(1-2), 23-30. doi: 10.1007/s00508-009-1291-7 
 
Kratzing, C. (2011). Pre-operative nutrition and carbohydrate loading. The Proceedings of the Nutrition 
Society, 70(3), 311-315. doi: http://dx.doi.org/10.1017/S0029665111000450 
 

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Nason, K. S. (2015). Acute Intraoperative Pulmonary Aspiration. Thoracic surgery clinics, 25(3), 301-
307. doi: 10.1016/j.thorsurg.2015.04.011 
 
Noblett, S., Watson, D., Huong, H., Davison, B., Hainsworth, P. & Horgan, A. (2006). Pre‐operative oral 
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563-569.  
 
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Preoperative gastric emptying. Effects of anxiety and oral carbohydrate administration. Annals of 
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10.1093/bjaceaccp/mkt053 
 
Tran, S., Wolever, T. M., Errett, L. E., Ahn, H., Mazer, C. D. & Keith, M. (2013). Preoperative 
carbohydrate loading in patients undergoing coronary artery bypass or spinal surgery. Anesth Analg, 
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28 
 
Pro forma 
 
 
Visual analogue scale 
Please place X along the line where you think you fit 
 
Before drink 
 
1. Current level of hunger 
 
2. Current level of thirst 
 
 
 
 
 
3. Current level of anxiety 
 
 
 
 
 
4. Current level of tiredness 
 
 
 
 
 
5. Current level of weakness 
 
 
 
 
 
 
Demographic  
 
 
 
 
 
 
 
ID number 
:_______________ Randomization 
:________________ 
Age (years old) 
:______________   
Gender 
o Male  
o Female  
Weight (Kg) 
:_______________ Height (cm) 
:_________________ 
BMI (kg/m2) 
:_______________  
 
 
 
 
 
 
 
End point evaluation 
 
 
 
 
 
 
 
Time of drink given  : ____:____H 
Time of scope 
: ____:____H 
Residual gastric volume (cc) 
:______________ 
 
 
Not at all 
The most imaginable 
Not at all 
The most imaginable 
Not at all 
The most imaginable 
Not at all 
The most imaginable 
Not at all 
The most imaginable 

29 
 
Before scope 
 
1. Current level of hunger 
    
2. Current level of thirst 
 
 
 
 
 
3. Current level of anxiety 
 
 
 
 
 
4. Current level of tiredness 
 
 
 
 
 
5. Current level of weakness 
 
 
 
 
 
Not at all 
The most imaginable 
Not at all 
The most imaginable 
Not at all 
The most imaginable 
Not at all 
The most imaginable 
Not at all 
The most imaginable 

30 
 
 
 
 
 
 
 
 
                
ATTACHMENT B 
 
RESEARCH INFORMATION 
 
 
Research Title 
: The effect of carbohydrate loading on gastric residual volume   
and hunger score 
 
Name of main and co-Researcher:  
Dr. Bee Chen Lua (MPM 61885),  
Dr. Michael Wong Pak Kai ( General surgeon HUSM, MPM 45546) 
Dr. Mohd Nizam Bin Md Hashim ( General surgeon HUSM, MPM 41057) 
 
 
INTRODUCTION 
 
You are invited to take part voluntarily in a research. This research is about Effect of carbohydrate 
loading on gastric residual volume and patient’s wellbeing. 
 
It is important that you read and understand this research information before agreeing to participate in 
this study. You will receive a copy of this form to keep for your records if you agree to participate. 
 
Your participation in this study is expected to be about 3 hours.  This study is estimated to include up 
to 78 participants. 
 
 
PURPOSE OF THE STUDY 
 
The purpose of this study are to determine and compare effect of carbohydrate drink and plain water 
towards gastric residual volume and patient’s well being. 
 
 
PARTICIPANTS CRITERIA 
 
The research team members will discussed your eligibility to participate in this study.  It is important 
that you are completely truthful with the staff including your health history [if relevant ONLY].   
 
This study will include individual who are above 18 years old 
 
This study will not incude individual who had history of upper gastrointestinal surgery, symptoms of 
intestinal obstruction such as vomiting, abdominal distension and mentally disabled subject.  
 
 
STUDY PROCEDURES 
 
All subjected planned for scope of stomach (oesophagogastroduodenoscope) with the complain of 
one or more of the following symptoms: Bothersome postprandial fullness, early satiation, Epigastric 
pain or Epigastric burning and fulfil inclusion criteria are selected. Patients will be approach and invited 
to join the study. Informed consent will be obtained after explanation regarding the study and procedure. 
They are randomised into 2 group:  
- 
Group 1 will be given 250cc plain water  
- 
Group 2 will be given 237cc resource (1 pack resource). 
 
2 hours after that, subject undergo scope. Scope is done follow standard protocol. Fluid remain in the 
stomach is aspirated until dry via endoscope and residual gastric volume is measured. 
 
Subject’s wellbeing is assessed via visual analogue scale (VAS) which consist of 5 parameters: hunger, 
thirst, anxiety, tiredness and weakness. This scale will be used repeatedly during this study to assess 

31 
 
patient’s wellbeing. Subject need to mark “X” somewhere along the horizontal line given before drink 
and before scope procedure. 
 
 
RISKS 
 
The possible risk that may arise from your participation in the study include injury to the 
gastrointestinal’s wall, aspiration and bleeding which is the similar risk for all patient going through 
oesophagogastroduodenoscope procedure. 
 
REPORTING HEALTH EXPERIENCES. 
 
Please contact, at any time, the following researcher if you experience any health problem either directly 
or indirectly related to this study.     
 
Dr. Bee Chen Lua [MMC Registration No. 61885]  
at +60 127107200 
 
PARTICIPATION IN THE STUDY 
 
Your taking part in this study is entirely voluntary.  You may refuse to take part in the study or you may 
stop your participation in the study at anytime, without any penalty or loss of benefits to which you are 
otherwise entitled.  
 
Your participation also may be stopped by the research team without your consent if in any form you 
have violated the study eligibility criteria. The research team member will discussed with you if the 
matter arises. 
 
POSSIBLE BENEFITS [Benefit to Individual, Community, University] 
 
The procedure undergo in this study will be provided to you with free. You will be informed about result 
of the endoscope and treatment provided. 
 
This study finding may benefit the community by knowing the effect of carbohydrate drink before 
procedure on patient’s well being and its safety to be used in future. 
 
You will not recieve any compensation from this study.  
 
QUESTIONS 
 
If you have any question about this study or your rights, please contact; 
 
Dr Bee Chen Lua & No. MMC 61885 
Department of general surgery 
School of medicine 
USM Health Campus 
+60 127107200 
 
If you have any questions regarding the Ethical Approval or any issue / problem related to this study, 
please contact; 
 
Mr. Mohd Bazlan Hafidz Mukrim 
Secretary of Human Research Ethics Committee USM 
Division of Research & Innovation (R&I) 
USM Health Campus 
Tel. No. : 09-767 2354 / 09-767 2362 
Email : bazlan@usm.my or jepem@usm.my 
 

32 
 
 
 
CONFIDENTIALITY 
 
Your information will be kept confidential by the researchers and will not be made publicly available 
unless disclosure is required by law. 
 
Data obtained from this study that does not identify you individually will be published for knowledge 
purposes. 
 
Your original records may be reviewed by the researcher, the Ethical Review Board for this study, and 
regulatory authorities for the purpose of verifying the study procedures and/or data.  Your information 
may be held and processed on a computer. Only research team members are authorized to access 
your information. 
 
By signing this consent form, you authorize the record review, information storage and data process 
described above. 
 
 
SIGNATURES 
 
To be entered into the study, you or a legal representative must sign and data the signature page 
[ATTACHMENT S and ATTACHMENT P] 

33 
 
 
 
 
 
ATTACHMENT S 
 
 
Subject Information and Consent Form 
(Signature Page) 
 
Research Title: 
The effect of carbohydrate loading on gastric residual volume   and 
hunger score 
Researcher’s Name:  Dr. Bee Chen Lua (MPM 61885), Dr. Michael Wong Pak Kai ( General 
surgeon HUSM, MPM 45546), Dr. Mohd Nizam Bin Md Hashim ( General 
surgeon HUSM, MPM 41057) 
 
To become a part this study, you or your legal representative must sign this page. By signing this page, 
I am confirming the following: 
 
▪ 
I have read all of the information in this Patient Information and Consent 
Form including any information regarding the risk in this study and 
I have had time to think about it.  
▪ 
All of m y questions have been answered to my satisfaction.  
▪ 
I voluntarily agree to be part of this research study, to follow the study 
procedures, and to provide necessary information to the doctor, nurses, 
or other staff members, as requested.  
▪ 
I may freely choose to stop being a part o f this study at anytime. 
▪ 
I have received a copy of this Participant Information and Consent Form 
to keep for m yself. 
 
 
 
 
Participant Name  
 
 
 
 
 
 
 
 
 
Participant I.C No 
 
 
 
 
 
 
 
 
 
Signature of Participant or Legal Representative 
 
 
Date (dd/MM/yy) 
 
 
 
Name of Individual  
Conducting Consent Discussion 
 
 
 
 
Signature of Individual  
 
 
 
 
 
Date (dd/MM/yy) 
Conducting Consent Discussion  
 
 
 
 
Name & Signature of Witness  
 
            
 
Date (dd/MM/yy) 
 
 
 
Note:  
i) 
All participants who are involved in this study will not be covered by insurance. 

34 
 
ATTACHMENT P 
 
 
Participant’s Material Publication Consent Form 
Signature Page 
 
Research Title: 
The effect of carbohydrate loading on gastric residual volume   and 
hunger score 
Researcher’s Name:  Dr. Bee Chen Lua (MPM 61885), Dr. Michael Wong Pak Kai ( General 
surgeon HUSM, MPM 45546), Dr. Mohd Nizam Bin Md Hashim ( General 
surgeon HUSM, MPM 41057) 
 
To become a part this study, you or your legal representative must sign this page.  
 
By signing this page, I am confirming the following: 
 
▪ 
I understood that my name will not appear on the materials published 
and there has been efforts to make sure that the privacy of my name is 
kept 
confidential 
although 
the 
confidentiality 
is 
not 
completely 
guaranteed due to unexpected circumstances.  
 
▪ 
I have read the materials or general description of what the material contains 
and reviewed all photographs and figures in which I am included that could 
be published.  
 
▪ 
I have been offered the opportunity to read the manuscript and to see all 
materials in which I am included, but have waived my right to do so.   
 
▪ 
All the published materials will be shared among the medical 
practitioners, scientists and journalist world wide.  
 
▪ 
The materials will also be used in local publications, book publications 
and accessed by many local and international doctors world wide.  
 
▪ 
I hereby agree and allow the materials to be used in other publications 
required by other publishers with these conditions:  
 
▪ 
The materials will not be used as advertisement purposes nor as 
packaging materials. 
 
▪ 
The materials will not be used out of contex – i.e.: Sample pictures will 
not be used in an article which is unrelated subject to the picture.  
 
 
 
 
Participant Name 
 
 
 
 
 
 
 
 
Participant I.C No. 
 
Participant’s Signature 
Date (dd/MM/yy) 
 
 
 
Name and Signature of Individual  
 
 
 
Date (dd/MM/yy) 
Conducting Consent Discussion  
 
Note:  
i) 
All participants who are involved in this study will not be covered by insurance.