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CTRI Number  CTRI/2024/05/067692 [Registered on: 20/05/2024] Trial Registered Prospectively
Last Modified On: 20/05/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Surgical/Anesthesia
Diagnostic 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   Measurements of stomach volumes in children posted for operations after intake of water or tender coconut water using Ultrasound 
Scientific Title of Study   Assessment of Gastric Volumes in Preoperative Paediatric Surgical Patients with intake of water or tender coconut water – An ultrasound based randomised controlled study 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Bindu Madhava Datta V 
Designation  Post Graduate in Department of Anaesthesiology  
Affiliation  Vijayanagar Institute of Medical Sciences, Rajiv Gandhi University of Health Sciences. 
Address  Department of Anaesthesiology, Vijayanagar Institute of Medical Sciences, Cantonment, Ballari.

Bellary
KARNATAKA
583104
India 
Phone  8660225703  
Fax    
Email  datta388@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Bindu Madhava Datta V 
Designation  Post Graduate in Department of Anaesthesiology  
Affiliation  Vijayanagar Institute of Medical Sciences, Rajiv Gandhi University of Health Sciences. 
Address  Department of Anaesthesiology, Vijayanagar Institute of Medical Sciences, Cantonment, Ballari.

Bellary
KARNATAKA
583104
India 
Phone  8660225703  
Fax    
Email  datta388@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Bala Bhaskar S 
Designation  Professor and Head, Department of Anaesthesiology 
Affiliation  Vijayanagar Institute of Medical Sciences, Rajiv Gandhi University of Health Sciences. 
Address  Department of Anaesthesiology, Vijayanagar Institute of Medical Sciences, Cantonment, Ballari.

Bellary
KARNATAKA
583104
India 
Phone  9880012349  
Fax    
Email  sbalabhaskar@gmail.com  
 
Source of Monetary or Material Support  
NIL 
 
Primary Sponsor  
Name  Vijayanagar Institute of Medical Sciences 
Address  Cantonment, Ballari, Karnataka, India 583104 
Type of Sponsor  Government medical college 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Bindu Madhava Datta V   Vijayanagar Institute of Medical Sciences  Department of Anaesthesiology Major OT Complex,Cantonment, Ballari, 583104
Bellary
KARNATAKA 
8660225703

datta388@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee, VIMS  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: 4||Measurement and Monitoring,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Tender Coconut water Group   Tender coconut water at 3ml/kg body weight administrated 2 hours prior to surgery (7AM). Gastric volume assessed at 7.00 AM followed by every 30 mins till 9.00AM 
Comparator Agent  Water group  Water at 3ml/kg body weight administrated 2 hours prior to surgery (7AM). Gastric volume assessed at 7.00 AM followed by every 30 mins till 9.00AM 
 
Inclusion Criteria  
Age From  4.00 Year(s)
Age To  12.00 Year(s)
Gender  Both 
Details  1. Patients of age 4 to 12 years of either gender admitted for elective surgeries with over night inpatient stay preoperatively.
2. ASA Physical Status I and II 
 
ExclusionCriteria 
Details  1. Patient / parent /LAR refusal for procedure.
2. Deviation from proposed fasting guidelines or oral intake advise.
3. Subjects with gastric motility disorders.
4. Subjects prone for aspiration.
5. Subjects on drugs that might affect gastric emptying 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
Gastric volume at 2 hours after intake of water or tender coconut water.  0 time (7 AM) every 30 min for 2 hours 
 
Secondary Outcome  
Outcome  TimePoints 
Basal gastric volume (gastric volume after overnight fasting) and gastric volume after
ingestion of liquids at 30 min, 60 min, 90 min and 120 min. 
Basal gastric volume (gastric volume after overnight fasting) and gastric volume after
ingestion of liquids at 30 min, 60 min, 90 min and 120 min. 
Gastric Antral CSA at different time intervals.  At 7.00AM(Basal) serial ultrasounds every half hourly following blender coconut water consumption 7.30AM 8.00AM 8.30 AM 9.00AM 
Non- acceptability of drink by children  7 AM 
Post operative nausea and vomiting.  6 hours following surgery  
Glucometric random blood sugar levels after induction.  After induction of Anaesthesia  
 
Target Sample Size   Total Sample Size="92"
Sample Size from India="92" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   N/A 
Date of First Enrollment (India)   03/06/2024 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="1"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary  
Thorough preoperative evaluation and necessary investigations are carried out and informed consent of patients / parents / assent of 4-12 years of age of either gender scheduled for elective surgeries are taken.

Children are randomly allotted to one of the 2 groups, to receive either plain water (Group A) or tender coconut water (Group B) by computer generated randomization via Research Randomizer software (www.randomizer.org). The allocation concealment is ensured using sequentially numbered opaque sealed envelope (SNOSE) technique. Only the investigator monitoring the patient postoperatively is blinded for the group allotment.

Nil per oral for both solids and liquids will be advised from 11PM- 7 AM on the day of scheduled surgery. During the preoperative evaluation, the patient will undergo gastric ultra sound examination in the ‘preinduction room’, to develop acquaintance with the patient and to reduce the anxiety of newer environment to the child on the day of surgery (the Preinduction room being about 50 feet from the sterile zone of the operating theater). No specific sedation is advised for the patients.

At 7 AM all the patients will undergo gastric ultrasound evaluation with SONOSITE-SII using high frequency paediatric linear probe (13 MHz- 6 MHz) (L25) or low frequency curve-linear probe (5 MHz- 2 MHz) (C60) (whichever provides best images). The basal gastric parameters will be noted in 2 groups (Group A and Group B). Intravenous fluid is not administered for the next 2 hours. The group A children receives plain water and group B children receive tender coconut water, both at 3ml/kg body weight. Ultrasonography assessment is next performed at 7.30 AM, 8.00AM, 8.30 AM and 9.00AM and gastric volumes and contents are noted.

Patient will be first scanned in a supine position, followed by right lateral position (RLP). In both positions, the gastric antrum will be identified. The ultrasonographic examination will be done by the post graduate under the supervision of the guide. The post graduate would have performed at least 50 examinations (10 patients) under guidance of the experienced guide in the pilot testing before actual recruitment of patients. A qualitative assessment will also be performed to identify material in the stomach (solid or liquid) and gastric antral grading, as described by Perlas et al as follows:

Grade 0= Absence of fluid in both supine and RLP;
Grade 1=fluid in RLP only;
Grade 2=fluid in both supine/semi recumbent and RLP;

Quantitative assessment will be performed by measuring antral cross-section area (CSA) and antral volume. The antral CSA will be calculated by measuring two perpendicular diameters. In longitudinal (D1) and anteroposterior (D2) plane from serosa to serosa and using the formula:      
CSA=π[D1×D2]/4.

Four measurements of gastric antral CSA will be obtained for each patient, supine position and three in RLD (averaged to obtain a mean value). The following mathematical model will be used to calculate the volume of gastric contents and to determine the volume in ml/kg.

Volume=27.0+ (14.6×CSA) - (1.28×Age)

The random blood glucose (RBS) will be checked with glucometer (ONE TOUCH SELECT) immediately on induction and time noted.

Data Management and Statistics: 
The data will be entered in MS Excel Sheet, cleaned, and the averages / means, proportions / percentages, gradings (descriptive statistics) are noted. The continuous variables related to the gastric volumes at different intervals (values in ml and as ml per Kg) are expressed in Mean Standard deviation (SD), and so will be the CSA (cm2). The Perla’s gastric antral grading – the ordered categorical variable will be expressed as proportion / percentages and so will be the grouping of patients based on different levels of gastric volume per kg and others related to the patient characteristics such as age, as necessary. The data will be checked for uniformity of distribution and if not, subjected to ‘goodness of fit’ tests for normalcy. For numerical data, for parametric data, Paired T test will be used within group and Student’s T test for 2 group comparison. For non-parametric data even after logarithmic correction, Wilcoxon signed rank test and Wilcoxon rank sum tests will be used for within group and unrelated samples respectively. For categorical variables, McNemar or Chi square test will be used for related or unrelated samples. The p values at <0.05 will be taken as significant for the purpose of the inferential statistical tests.
 
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