FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2019/02/017425 [Registered on: 04/02/2019] Trial Registered Prospectively
Last Modified On: 21/05/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Surgical/Anesthesia 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   To study the effect of two different amount of clear liquid ingestion on total volume of stomach, its emptying time (rate of clearing of fluid from stomach) and remaining volume (residual volume) in children undergoing elective surgery 
Scientific Title of Study   Ultrasonographic estimation of gastric emptying and residual volume after ingestion of two different quantities of clear fluid in children. A double blinded randomised controlled study 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Sadik Mohammed 
Designation  Assistant Professor 
Affiliation  AIIMS Jodhpur 
Address  Near Mohammedi Masjid, Hanuman Ji Ki Bhakhari, Nai Sarak, Jodhpur. Rajastha
All India institute of medical sciences, HI Area Phase II, Basni, Jodhpur, Rajasthan 342005
Jodhpur
RAJASTHAN
342001
India 
Phone  9414849733  
Fax    
Email  drmsadik@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Sadik Mohammed 
Designation  Assistant Professor 
Affiliation  AIIMS Jodhpur 
Address  Near Mohammedi Masjid, Hanuman Ji Ki Bhakhari, Nai Sarak, Jodhpur. Rajastha
All India institute of medical sciences, HI Area Phase II, Basni, Jodhpur, Rajasthan 342005
Jodhpur
RAJASTHAN
342001
India 
Phone  9414849733  
Fax    
Email  drmsadik@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Sunny Taye 
Designation  PG Student 
Affiliation  AIIMS Jodhpur 
Address  452, Saraswati Nagar, Krishi Mandi Road, Near Nasrani Bioscope Cinema.
All India institute of medical sciences, HI Area Phase II, Basni, Jodhpur, Rajasthan 342005
Jodhpur
RAJASTHAN
342005
India 
Phone  08724983419  
Fax    
Email  sunnytaye91@gmail.com  
 
Source of Monetary or Material Support  
AIIMS Jodhpur 
 
Primary Sponsor  
Name  AIIMS Jodhpur 
Address  Basani Industrial Area, Phase II, Jodhpur. 342001 
Type of Sponsor  Research institution and hospital 
 
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 Sadik Mohammed  AIIMS, Jodhpur  Basni industrial Area HI Area Phase 2 Basni jodhpur
Jodhpur
RAJASTHAN 
9414849733

drmsadik@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
AIIMS Institutional Ethical Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: R638||Other symptoms and signs concerning food and fluid intake,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Group A  5% dextrose water (clear fluid) 3 ml/kg will be allowed to drink after fasting. 
Comparator Agent  Group B  5% dextrose water (clear fluid) 5 ml/kg will be allowed to drink after fasting 
 
Inclusion Criteria  
Age From  6.00 Year(s)
Age To  14.00 Year(s)
Gender  Both 
Details  belonging to ASA physical status class I or II, fasted as per guidelines and scheduled for elective surgery. 
 
ExclusionCriteria 
Details  Children with gastrointestinal disease (gastro oesophageal reflux, hiatus hernia, or gastritis), presence of any major co-existing medical illness or congenital disorder, undergoing emergency surgery, violation of the prescribed fasting times, and refusing to drink prescribed clear fluid according to the protocol. 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant and Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
To compare time taken for the gastric volume to return at baseline after ingestion of two different quantities (3 and 5 ml/kg) of clear liquid and thereby to determine gastric emptying time and residual gastric volume.  To compare time taken for the gastric volume to return at baseline after ingestion of two different quantities (3 and 5 ml/kg) of clear liquid and thereby to determine gastric emptying time and residual gastric volume. 
 
Secondary Outcome  
Outcome  TimePoints 
To compare incidence of nausea and vomiting.
To compare incidence of irritability.
To compare Postoperative Satisfaction of Parents and Children. 
AFter surgery till 24 hours 
 
Target Sample Size   Total Sample Size="44"
Sample Size from India="44" 
Final Enrollment numbers achieved (Total)= "44"
Final Enrollment numbers achieved (India)="44" 
Phase of Trial   N/A 
Date of First Enrollment (India)   11/02/2019 
Date of Study Completion (India) 30/10/2020 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="20"
Months="2"
Days="1" 
Recruitment Status of Trial (Global)
Modification(s)  
Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details
Modification(s)  
Taye S, Mohammed S, Bhatia P, Kumar M, Chhabra S, Kumar R, Kumari K. Gastric emptying time of two different quantities of clear fluids in children: A double-blinded randomized controlled study. Paediatr Anaesth. 2021 Nov;31(11):1187-1193. 
Individual Participant Data (IPD) Sharing Statement

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

Response - YES
  1. What data in particular will be shared?
    Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).

  2. What additional supporting information will be shared?
    Response -  Study Protocol
    Response -  Statistical Analysis Plan
    Response - Informed Consent Form

  3. Who will be able to view these files?
    Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.

  4. For what types of analyses will this data be available?
    Response - For individual participant data meta-analysis.

  5. By what mechanism will data be made available?
    Response (Others) -  By personal request through mail at drmsadik@gmail.com

  6. For how long will this data be available start date provided 04-07-2021 and end date provided 04-04-2026?
    Response - Beginning 9 months and ending 36 months following article publication.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NIL
Brief Summary
Modification(s)  

Background: Perioperative pulmonary aspiration risk increases with increased preoperative gastric volume; hence traditionally, patients are kept fasted overnight before surgery. Current guidelines recommend 2-hours clear fluids fasting prior to anaesthesia. However, emerging evidence favours allowing 3 mL/kg clear fluids up to 1-hour before anaesthesia. We compared the gastric volume and gastric emptying time after ingestion of 3 mL/kg and 5 mL/kg of clear fluids.

Methods: Forty-four children were enrolled after getting informed and written consent from parents. On the day of surgery, baseline gastric volume was estimated using ultrasound and patients were randomly allocated in to two groups of equal number i.e. Group 3 and Group 5 (patients received 3 mL/kg and 5 mL/kg 5% Dextrose respectively). Repeated gastric ultrasound was done at every five-minutes interval until the gastric volume reached at baseline. The primary objective of the study was to compare gastric volume and gastric emptying time while secondary objectives were occurrence of PONV, occurrence of irritability and parent’s satisfaction.

Results: The demographic profile, preoperative fasting duration and baseline gastric volume was comparable between groups. In both groups, compared to baseline the gastric volume increased significantly following fluid ingestion and then decreased exponentially to reach at baseline within 1-hour. The median (IQR) gastric emptying time and emptying t1/2 (minutes) in group 3 was 35.0 (28.75, 40.0) and 17.00 (15.73, 21.50) respectively while in group 5 it was 40.0 (28.75, 45.0) and 18.55 (15.98, 21.98) respectively (p=0.16 and p=0.44 respectively).  The occurrence of nausea, vomiting and irritability as well as parent satisfaction were comparable between the groups (p>0.05).

Conclusion: As the gastric volume returned to baseline within 1-hour even after ingesting 5 mL/kg clear fluids, the preoperative fasting time can be reduced to 1-hour and children can be safely allowed to drink up to 5 mL/kg clear fluids.

 
Close