FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2024/06/068716 [Registered on: 11/06/2024] Trial Registered Prospectively
Last Modified On: 11/06/2024
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   Measurement of Stomach Volumes in children undergoing operation after intake of water or Apple juice, using ultrasound machine 
Scientific Title of Study   Assessment of Gastric Volumes in Preoperative Paediatric surgical patients with intake of water or Apple juice- 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 Lakshmegowda C A  
Designation  Junior Resident in Department of Anaesthesiology and Critical Care 
Affiliation  Vijayanagar Institute of Medical Sciences Ballari 
Address  Department of Anaesthesiology, Vijayanagar Institute of Medical Sciences, Cantonment, Ballari

Bellary
KARNATAKA
583104
India 
Phone  9108345003  
Fax    
Email  lakshmegowda10@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Lakshmegowda C A  
Designation  Junior Resident in Department of Anaesthesiology and Critical Care  
Affiliation  Vijayanagar Institute of Medical Sciences Ballari 
Address  Department of Anaesthesiology, Vijayanagar Institute of Medical Sciences,Cantonment, Ballari

Bellary
KARNATAKA
583104
India 
Phone  9108345003  
Fax    
Email  lakshmegowda10@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Bala Bhaskar S 
Designation  Professor 
Affiliation  Vijayanagar Institute of Medical Sciences  
Address  Dep of Anaesthesiology Vijayanagar Institute of Medical Sciences Ballari

Bellary
KARNATAKA
583103
India 
Phone  9880012349  
Fax    
Email  sbalabhaskar@gmail.com  
 
Source of Monetary or Material Support  
Nil 
 
Primary Sponsor  
Name  Vijayanagar Institute of Medical Sciences  
Address  Department of Anaesthesiology and Critical Care Vijayanagar Institute of Medical Sciences, Cantonment, Ballari 585104 India  
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 Lakshmegowda C A  Vijayanagar Institute of Medical Sciences  Department of Anaesthesiology and Critical Care, Major OT Complex, Cantonment, Ballari 583104
Bellary
KARNATAKA 
9108345003

lakshmegowda10@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethical Committee, Vijayanagar Institute of Medical Sciences, Ballari   Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: O||Medical and Surgical, (2) ICD-10 Condition: Z768||Persons encountering health services in other specified circumstances,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Apple group  Apple Juice at 3 ml/kg administered at 7 AM (2 hours before surgery). Gastric assessment performed at 7 AM and every 30 mins till 9 AM Total duration- 2hrs 
Comparator Agent  Water group  Water at 3 ml/kg administered at 7 AM (2 hours before surgery). Gastric assessment performed at 7 AM and every 30 mins till 9 AM Total duration - 2hrs 
 
Inclusion Criteria  
Age From  4.00 Year(s)
Age To  12.00 Year(s)
Gender  Both 
Details  1.Patients of age 4 to12 years, of either gender admitted for elective surgeries with overnight inpatient stay preoperatively and 8 hours of fasting.
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 apple juice  0 time (7 AM) every 30min for 2 hrs 
 
Secondary Outcome  
Outcome  TimePoints 
1 Basal gastric volume (gastric volume after overnight fasting) & gastric after ingestion of liquids at 30min, 60min, 90min, & 120min.
2 Gastric Antral CSA at different time intervals
3 Non - acceptability of drink by children
4 Post operative nausea & vomiting
5 Glucometric random blood sugar levels after induction 
Basal gastric volume (gastric volume after overnight fasting) & gastric after ingestion of liquids at 30min, 60min, 90min, & 120min.
At 7:00AM (Basal) serial ultrasounds every half hourly following blender coconut water consumption 7:30AM 8:00AM 8:30AM 9:00AM
7AM
6 Hours following surgery
After induction of Anaethesia 
 
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)   01/07/2024 
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   Pre operative mandatory fasting is a safety precaution intended to decrease gastric content and improve pH to protect from regurgitation and pulmonary aspiration under anaesthesia and deep sedation gastric emptying depends on type and volume of different contents as well as time duration since last intake. Perioperative pulmonary aspiration though not frequent (0.020.1%), is a serious anaesthetic complication with morbidity and mortality. Aspiration risk is especially corelated to duration of fasting in all age groups including paediatric population.

 Indian Society of Anaesthesiologists [ISA] has laid down mandatory NPO guidelines according to which 6 hours fasting for solid food and non-human milk, 4 hours for breast milk, water up to 3ml/kg body weight allowed till 1 hour prior to administration of anaesthesia and for clear liquids other than water (up to 3ml/kg) till 2 hours prior to administration of anaesthesia in paediatric population.

 American Society of Anesthesiologists [ASA] preoperative fasting guidelines for paediatric population recommends 2 hours of fasting for clear fluids, while another the recent guidelines mentions that there is insufficient evidence concerning clear liquid 1 hour prior to anaesthesia. 

 The more recent guidelines of European Society of Anaesthesiology and Critical Care for paediatric population highly recommends that healthy children be encouraged to drink clear fluids (including water with or without sugar, pulp free fruit juices, and milk free tea or coffee) up to 1 hour before anaesthesia induction for elective procedures, but with low-quality evidence.

 Undue prolongation of fasting period in children is observed due to many factors which may lead to dehydration, hypoglycaemia, patient anxiety and discomfort. 
ERAS protocols for paediatric population advise that the child consumes a preoperative carbohydrate-rich drink 2 hours prior to surgery at home or in the preoperative holding area along with other premedication with overall goal of reducing the negative effects of anaesthetic and surgical intervention so that patients can recover quickly with fewer complications and have greater satisfaction. 

A few prospective observational studies and RCTs have compared preoperative carbohydrate oral drinks and clear liquids such as apple juice and observed that residual gastric volume will be same or lesser compared to group not having clear fluids, with better patient satisfaction, overall well-being, reduced PONV, less antiemetic use, better perioperative glycemic profile without risk of pulmonary aspiration.
 Gastric sonography is a bed side non-invasive, point of care tool that can reliably provide valuable information related to both the quantitative and qualitative aspects of gastric contents.

 Study of gastric emptying with respect to Indian paediatric population is inadequate, hence this study aims to evaluate influence of preoperative water or apple juice as the clear fluid on gastric volume at 2 hour by ultrasonography as the primary objective. 
 
Close