| CTRI Number |
CTRI/2025/06/088816 [Registered on: 13/06/2025] Trial Registered Prospectively |
| Last Modified On: |
13/06/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
To evaluate if fasting a child offer any benefit in reducing stomach content of fluid before surgery |
|
Scientific Title of Study
|
Evaluation of gastric volumes after preoperative drink 2hours prior to surgery versus controls in children undergoing abdominal surgery |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Lakshmi Kumar |
| Designation |
Professor and Head |
| Affiliation |
Amrita Institute of Medical Sciences |
| Address |
Department of Anaesthesia and Critical care
Tower 6 floor 1
AIMS
Kochi
Ernakulam
KERALA
682041
India |
| Phone |
9496211333 |
| Fax |
914842852020 |
| Email |
lakshmi.k.238@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Lakshmi Kumar |
| Designation |
Professor and Head |
| Affiliation |
Amrita Institute of Medical Sciences |
| Address |
Department of Anaesthesia and Critical care
Tower 6 floor 1
AIMS
Kochi
KERALA
682041
India |
| Phone |
9496211333 |
| Fax |
914842852020 |
| Email |
lakshmi.k.238@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Athira Soman |
| Designation |
Fellow Pediatric Anaesthesia |
| Affiliation |
Amrita Institute of Medical Sciences |
| Address |
Department of Anaesthesia and Critical care
Tower 6 Floor 1 AIMS Kochi 682041
Tower 6 Floor 1
Ernakulam
KERALA
Lakshmi Kumar
India |
| Phone |
9108585416 |
| Fax |
914842852020 |
| Email |
athirasoman25@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Amrita Institute Of Medical Sciences |
| Address |
Department of Anaesthesia and Critical care
Tower 6 Floor 1
AIMS
Kochi 682041 |
| Type of Sponsor |
Private medical college |
|
|
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 Lakshmi Kumar |
Amrita Institute Of Medical Sciences |
Department of Anaesthesia and Critical care
Tower 6 Floor 1
AIMS Kochi
Ernakulam
KERALA |
9496211333
914842852020
lakshmi.k.238@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| AIMS Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O||Medical and Surgical, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Children are kept nil by mouth for 6 hours pre-operatively and gastric volume assessed after intubation |
A maintenance fluid of Isolyte P is given as per calculation from the time of fasting until surgery.After intubation gastric cross sectional area is obtained by ultrasound and gastric volume calculated by the formula
-7.8 + (3.5 x 4.88) +0.127 x age in months |
| Intervention |
Preoperative apple juice given upto 2 hours before surgery and gastric volumes are measured after intubation |
Children are instructed to take apple juice as per their thirst to a maximum of 200 ml given between 21/2 and 2 hours before surgery. After intubation , using an ultrasound the gastric cross sectional area is obtained and the residual volume calculated by the formula -7.8 + (3.5 x 4.88) +0.127 x age in months |
|
|
Inclusion Criteria
|
| Age From |
1.00 Year(s) |
| Age To |
8.00 Year(s) |
| Gender |
Both |
| Details |
Children undergoing elective abdominal surgery |
|
| ExclusionCriteria |
| Details |
1. Emergency surgeries
2. Child with outlet obstruction gastric,
duodenal, jejunal or large bowel
3. Vomiting
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Gastric volume measured after intubation by ultrasound in children given oral apple juice versus children kept nil orally for 6 hours |
2 hours after oral apple juice
or 6 hours after food |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. Comfort levels of the child at separation
2. Measurement of Ryle’s tube aspirate.
3. Blood glucose measured after intubation between both groups
|
1. 2 h after oral liquid or 6 hours after food
|
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
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)
|
30/06/2025 |
| 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="0"
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
|
Safety of clear liquids even until 1 h prior to surgery is being accepted. However, surgical specialties fear that gastric volumes may pose aspiration risks or delay their cases. This study is designed to provide actual gastric volumes to document safety even amongst surgical specialties on safety in admi nistering clear fluids to children |