The Effect of A Newly Formulated Preoperative Oral Carbohydrate Solution on Gastric Emptying, Postoperative Nausea and Vomiting and Stress Response
Phase: NA
Conditions: Vomit Aspiration, Anxiety
Sponsor: Bezmialem Vakif University

 
KLİNİK ARAŞTIRMALAR ETİK KURULU 
 ÇALIŞMA PROTOKOLÜ 
Doküman Kodu: ÜNV-KAEK-DYD-005 
Yayın Tarihi: 30.03.2022 
Revizyon No: 01 
Revizyon Tarihi: 01.06.2022 
Sayfa 1 / 5 
 
STUDY PROTOCOL      
 
1. Date: 01.01.2023 
2. Official Title: 
THE EFFECT OF A NEWLY FORMULATED PREOPERATIVE ORAL CARBONHYDRATE 
SOLUTION ON GASTRIC EMPTYING, POSTOPERATIVE NAUSEA AND VOMITING AND 
STRESS RESPONSE   
 
3. Method: 
 
109 patients who underwent elective laparoscopic cholecystectomy, aged 18-65 years and ASA physical 
state 1-2 were included in the study. The patients were divided into 3 groups: Group A, who would not eat 
anything 6-8 hours before the operation, Group S, who drank 400 ml of water 2 hours before the operation, 
and Group K, which drank 400 ml preoperative oral carbohydrate solution (PreOKH) 2 hours before the 
operation. Before induction of anesthesia (T1), patients antral gastric cross-sectional area (GKA) and 
gastric volume (GV) were evaluated by gastric ultrasound. The preoperative anxiety level of the patients 
was determined by the State-Trait Anxiety Inventory (STAl) before the operation (T1), and the symptoms 
affecting the preoperative patient comfort parameters (thirst, hunger, dry mouth, fatigue) were measured 2 
hours before the operation (T0) and before the induction (T1) evaluated with the visual analog scale (VAS). 
Postoperative nausea and vomiting (PONV) and postoperative pain levels were recorded. Blood glucose, 
insulin and cortisol levels of the patients were measured 2 hours before the operation (T0), before induction 
(T1) and postoperative 2nd hour (T3). 
 
  Descriptive statistics of qualitative variables in the study will be given as number and percentage, and 
descriptive statistics of quantitative variables will be given as mean, median, standard deviation, minimum 
and maximum.  Pearson chi-square and Fisher's exact chi-square tests will be used to compare the 
distribution of the relevant variables between the groups.  The conformity of quantitative variables to 
normal distribution will be examined by Shapiro Wilk test. For normally distributed variables, one-way 
analysis of variance will be used to compare the means of more than two groups. Tukey test will be used as 
a posthoc test for pairwise comparisons. For non-normally distributed variables, Kruskall Wallis test will 
be used in the mean comparison of more than two groups and pairwise comparisons will be examined with 
Dunn test. Paired t test will be used for the mean comparison of two dependent groups and Wilcoxon 
signed-rank test will be used for median comparisons. Repeated measures analysis of variance method will 
be used for mean comparisons of more than two dependent groups and Friedman test will be used for 
median comparisons. Statistical significance level will be taken as 0.05 and SPSS (Version 28) package 
program will be used for calculations.  For the gastric volume value, at the 95% confidence level, when the 
significance of a mean difference of 18.18 with 80% power is attributed (means 67.22 and 49.04 with 
standard deviations 29.49 and 15.4), a minimum of 28 people should be included in the study in each 
group. [1] Therefore, we planned the number of patients in the study groups as 30 for each group.1 
                                                
 
 
 
 
 
 
 
 
 
 
 
 
 

 
KLİNİK ARAŞTIRMALAR ETİK KURULU 
 ÇALIŞMA PROTOKOLÜ 
Doküman Kodu: ÜNV-KAEK-DYD-005 
Yayın Tarihi: 30.03.2022 
Revizyon No: 01 
Revizyon Tarihi: 01.06.2022 
Sayfa 2 / 5 
 
 
 
 
 
 
Inclusion Criteria: 
 
1. Between the ages of 18-65 
2. Elective laparoscopic cholecystectomy planned under general anesthesia 
3. American Society of Anesthesiologists (ASA) class I-II physical condition 
 
Exclusion Criteria: 
 
1. Patients with gastroesophageal reflux and gastrointestinal motility disorders 
2. diabetes mellitus 
3. Mental retardation, previous neurological disease symptoms (syncope, dementia, alzheimer etc.) 
4. Chronic alcoholism 
5. Difficult Intubation 
6. Patients with ASA physical status classes ≥III 
7. Patients with a body mass index of 35 and above 
8. History of meniere and motion sickness 
9. Presence of previous history of postoperative nausea and vomiting 
10. Smoking 
 
 
 
Numerik Rank Score:  
 0: no vomiting or nausea  
 1: nausea 
 2:nausea and once vomiting 
 3:twice or more vomiting 
 
VAS: 
  
 
 
Qualitative evaluation of the antrum with gastric USG: 
Grade 0: empty antrum both in the semi-sitting position and in the RLDP 
Grade 1: gastric fluid is only visible in RLDP;  
Grade 2: gastric fluid can be seen both in the semi-sitting position and in RLDP 

 
KLİNİK ARAŞTIRMALAR ETİK KURULU 
 ÇALIŞMA PROTOKOLÜ 
Doküman Kodu: ÜNV-KAEK-DYD-005 
Yayın Tarihi: 30.03.2022 
Revizyon No: 01 
Revizyon Tarihi: 01.06.2022 
Sayfa 3 / 5 
 
 

 
KLİNİK ARAŞTIRMALAR ETİK KURULU 
 ÇALIŞMA PROTOKOLÜ 
Doküman Kodu: ÜNV-KAEK-DYD-005 
Yayın Tarihi: 30.03.2022 
Revizyon No: 01 
Revizyon Tarihi: 01.06.2022 
Sayfa 4 / 5 
 
 
FOLLOW-UP FORM 
 
Gastric examination 
 
 
Gastrik USG – measurement of  CSA in RLPD 
(CSA = (LD × SD × π )/4) 
LD: 
SD: 
CSA: 
Gastric volume 
(GV = 27,0 + 14,6 × CSA ( RLDP'de ) − 1,28 × age) 
 
Qualitative evaluation score 
 
Gastiric volume (aspiration of ngs) 
 
Gastric pH 
 
 
İntraoperative vital sing 
No: 
 
Duration of operation 
 
Age-gender 
 
Fasting time 
 
BMI 
 
Anesthetic agent consumption 
Sevoflurane: 
GRUP 
 
Remifentanil: 
ASA 
 
complications: 
 
disease 
          
Antiemetic need : 
 
 
HR 
SP/DP 
MAP 
SpO2 
BİS 
Before induction 
 
 
 
 
 
İnd +1. min 
 
 
 
 
 
10.min 
 
 
 
 
 
20.  min 
 
 
 
 
 
30. min 
 
 
 
 
 
40. min 
 
 
 
 
 
50. min 
 
 
 
 
 
60. min 
 
 
 
 
 
Before extubation 
 
 
 
 
 
After extubation 
 
 
 
 
 

 
KLİNİK ARAŞTIRMALAR ETİK KURULU 
 ÇALIŞMA PROTOKOLÜ 
Doküman Kodu: ÜNV-KAEK-DYD-005 
Yayın Tarihi: 30.03.2022 
Revizyon No: 01 
Revizyon Tarihi: 01.06.2022 
Sayfa 5 / 5 
 
 
 
 
 
 
 
 
 
Koordinatör: Prof. Dr. Kazım Karaaslan 
İmza 
References 
1) Zhang Z, Wang RK, Duan B, Cheng ZG, Wang E, Guo QL, Luo H. Effects of a Preoperative 
Carbohydrate-Rich Drink Before Ambulatory Surgery: A Randomized Controlled, Double-Blinded 
Study. Med Sci Monit. 2020 Aug 28;26:e922837. doi: 10.12659/MSM.922837 
 
 
 
PACU 1. min 
 
 
 
 
 
PACU 15.min 
 
 
 
 
 
 
STAI 
VAS 
PONK 
Glucose 
Insulin  
cortisole 
Preop 2. hours 
 
 
 
 
 
 
Berofe induction 
 
 
 
 
 
 
PACU 
 
 
 
 
 
 
Postop 2. hours 
 
 
 
 
 
 
Postop 12.  hours 
 
 
 
 
 
 
discharge