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CTRI Number  CTRI/2021/04/032882 [Registered on: 16/04/2021] Trial Registered Prospectively
Last Modified On: 29/05/2023
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Observational 
Study Design  Other 
Public Title of Study   Comparison study between preoperative standard fasting hours and gastric aspirate pH in paediatric age group  
Scientific Title of Study   Comparative study of residual gastric volume using ultrasound following preoperative fasting regimen of 6hr-4hr-2hr in paediatric age group undergoing general anaesthesia and relation with gastric pH;A hospital based prospective, observational study 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  DrRhea Thotungal 
Designation  Academic junior resident 
Affiliation  All india institute of medical sciences,Bhopal 
Address  Aiims pg girls hostel, aiims bhopal,saketh nagar
AIIMS BHOPAL,saketh nagar,462021
Bhopal
MADHYA PRADESH
462021
India 
Phone  7225800624  
Fax    
Email  rheat1992@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Jai prakash sharma 
Designation  Professor,department of anaesthesiology and critical care 
Affiliation  AIIMS BHOPAL 
Address  AIIMS BHOPAL,SAKETH NAGAR,462020
Aiims pg girls hostel, aiims bhopal,saketh nagar
Bhopal
MADHYA PRADESH
462020
India 
Phone  9425609647  
Fax    
Email  drjpsharma100@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Jai prakash sharma 
Designation  Professor,department of anaesthesiology and critical care 
Affiliation  AIIMS BHOPAL 
Address  AIIMS BHOPAL,SAKETH NAGAR,462020
Aiims pg girls hostel, aiims bhopal,saketh nagar
Bhopal
MADHYA PRADESH
462020
India 
Phone  9425609647  
Fax    
Email  drjpsharma100@gmail.com  
 
Source of Monetary or Material Support  
Not applicable 
 
Primary Sponsor  
Name  DrJai prakash sharma 
Address  Professor,Department of Anaesthesiology,AIIMS BHOPAL 
Type of Sponsor  Government medical college 
 
Details of Secondary Sponsor  
Name  Address 
DrPoojs singh  Associate professor,department of anaesthesiology,AIIMS BHOPAL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
J p sharma  All india institute of medical sciences,bhopal  Department of anaesthesiology and critical care, modular operation theatre,2nd floor,AIIMS hospital
Bhopal
MADHYA PRADESH 
9425609647

drjpsharma100@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
IHEC-PGR, AIIMS BHOPAL  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: Q00-Q99||Congenital malformations, deformations and chromosomal abnormalities, (2) ICD-10 Condition: L00-L99||Diseases of the skin and subcutaneous tissue, (3) ICD-10 Condition: N50||Other and unspecified disorders ofmale genital organs,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Ultrasound guided gastric antrum volume assessment and gadtric ph  Ultrasound guided gastric volume assessment after following preoperative fasting of 6hr,4hr and 2hrs and once patient is given general anaesthesia gastric aspirate is taken 
 
Inclusion Criteria  
Age From  6.00 Year(s)
Age To  18.00 Year(s)
Gender  Both 
Details  Asa 1 and asa 2 patients undergoing general aneathesia 
 
ExclusionCriteria 
Details  Age less than 6yrs & more than 18yrs
Patients with gastroesophageal disease
Patients with poor GCS
Patients undergoing emergency procedure 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
To compare the residual gastric volume following preoperative fasting regimen and realtion with gastric ph  6hrs after fasting for solids
4hrs for liquids
2hrs for clear water 
 
Secondary Outcome  
Outcome  TimePoints 
To calculate residual gastric volume using ultrasonography in paediatric and adolescent age group
To find if there is any relationship between residual gastric volume and preoperative dasting hours 
6hrs after fasting for solids
4hrs after fasting for liquids
2hrs fasting for clear water 
 
Target Sample Size   Total Sample Size="60"
Sample Size from India="60" 
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="100" 
Phase of Trial   N/A 
Date of First Enrollment (India)   30/04/2021 
Date of Study Completion (India) 31/12/2021 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="0"
Months="8"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  
Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details   NA 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary   Preoperative fasting is an important  step to prevent postoperative complications like aspiration,post operative nausea,vomiting etc.Since Mendelson’s publication of the article regarding fatal consequences of aspiration of gastric contents preoperative fasting guidelines have evolved over the years.Presently the guidelines : 6hrs for solids,4hrs for liquids and 2hrs for clear fluids are followed internationally.But it is noticed that there is an excessive fasting time among patients as a result of fear of postponement of surgery,miscommunication etc.Though recent studie have shown that there is not much increase in incidence of  aspiration in children who are allowed to take fluids upto 1 hour prior to surgery the data is limited.So with this study  we are aiming to assess the gastric volume at different hours of preoperative fasting using ultrasound in prescribed age group and  to see if there is any relationship between gastric ph and gastric volume.Our hypothesis is that if there is no considerable change in the gastric ph there is provision to decrease our  standard fasting hours. 
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