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
|
|
Primary Sponsor
|
Name |
AIIMS Jodhpur |
Address |
Basani Industrial Area, Phase II, Jodhpur. 342001 |
Type of Sponsor |
Research institution and hospital |
|
Details of Secondary Sponsor
|
|
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
|
|
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
- 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).
- What additional supporting information will be shared?
Response - Study Protocol Response - Statistical Analysis Plan Response - Informed Consent Form
- 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.
- For what types of analyses will this data be available?
Response - For individual participant data meta-analysis.
- By what mechanism will data be made available?
Response (Others) - By personal request through mail at drmsadik@gmail.com
- 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.
- 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. |