| CTRI Number |
CTRI/2025/02/080580 [Registered on: 14/02/2025] Trial Registered Prospectively |
| Last Modified On: |
16/03/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Change of volume of stomach in children before and after surgery |
|
Scientific Title of Study
|
Pre-operative and end-operative gastric volumes in paediatric age group patients undergoing elective and emergency surgeries: An Observational Cross-Sectional Study |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Kartik Karan |
| Designation |
Post Graduate Resident |
| Affiliation |
AIIMS, Bilaspur |
| Address |
4th Floor, Block D, OT Complex, Department of Anaesthesiology and Critical Care, AIIMS Bilaspur
Bilaspur
HIMACHAL PRADESH
174001
India |
| Phone |
|
| Fax |
|
| Email |
kartikkaran1111@outlook.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Vijayalakshmi Sivapurapu |
| Designation |
Additional Professor and HOD |
| Affiliation |
AIIMS, Bilaspur |
| Address |
OT Complex 1, 4th Floor, Block D, AIIMS, Bilaspur
Bilaspur
HIMACHAL PRADESH
174001
India |
| Phone |
9442176549 |
| Fax |
|
| Email |
prerana1010@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Vijayalakshmi Sivapurapu |
| Designation |
Additional Professor and HOD |
| Affiliation |
AIIMS, Bilaspur |
| Address |
OT Complex 1, 4th Floor, Block D, AIIMS, Bilaspur
Bilaspur
HIMACHAL PRADESH
174001
India |
| Phone |
9442176549 |
| Fax |
|
| Email |
prerana1010@gmail.com |
|
|
Source of Monetary or Material Support
|
| AIIMS Bilaspur
Bilaspur 174001
Himachal Pradesh, India |
|
|
Primary Sponsor
|
| Name |
AIIMS Bilaspur |
| Address |
AIIMS Kothipura, Bilaspur, 174001 |
| Type of Sponsor |
Government 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 Kartik Karan |
AIIMS Bilaspur |
Department of Anaesthesiology and Critical Care, OT Complex, 4th Floor, Block D, AIIMS, Bilaspur
Bilaspur
HIMACHAL PRADESH |
8376994751
kartikkaran1111@outlook.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institute Ethics Committee (Biomedical & Health Research) |
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
Modification(s)
|
| Type |
Name |
Details |
| Intervention |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
2.00 Year(s) |
| Age To |
18.00 Year(s) |
| Gender |
Both |
| Details |
(1) Paediatric patients of age group (2 years to 18 years) undergoing elective or emergency
surgeries
(2) Male or Female gender
(3) ASA physical status I-II |
|
| ExclusionCriteria |
| Details |
(1) Patient with known abnormal upper gastrointestinal anatomy or prior upper
gastrointestinal surgery or currently undergoing upper GI surgery
(2) Patients with history of GERD, diabetes mellitus, renal disease
(3) Patient who had vomited since most recent oral intake or upto 4hrs prior to
surgery
(4) Patients with wounds of the epigastrium precluding probe placement
(5) Patients who will be unable to tolerate USG positioning
(6) Patients who are deemed critically ill by the treating team
(7) Patients whose parents refused to give consent
(8) Non cooperative patient |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To correlate pre-operative gastric volumes with preoperative fasting times |
Before the initiation of induction of anaesthesia in the pre-op area and before reversal or arousal from anaesthesia |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
I. To correlate pre-operative with the end-operative values of gastric volume in adequately
fasted vs non-fasted patients.
II. To compare the average end-operative gastric volumes in patients who underwent
intravenous versus inhalational induction and to correlate the total duration of surgery
with the end-operative gastric volumes and end-operative gastric volumes with presence
or absence of PONV (upto 6 hours post-op)
III. To correlate iGel secretions volume with the gastric volumes, total fentanyl usage, BM
V duration and surgery duration
|
Pre op and End op |
|
|
Target Sample Size
|
Total Sample Size="107"
Sample Size from India="107"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="0" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
23/02/2025 |
| Date of Study Completion (India) |
22/10/2025 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
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
|
After obtaining parental consent, a brief history of the child (age, gender, height, weight, BMI, complaints, medical history, allergies, and recent oral intake) will be recorded. The primary investigator, guided by a supervisor, will perform gastric ultrasounds before and after surgery. An IV line will be placed either in the pre-op area or after induction in the operating room. Using a high-frequency ultrasound probe, gastric ultrasonography will be done in two phases: - Pre-op (first reading) in the holding area.
- End-op (second reading) in the operating room.
In the pre-op phase, the child will be placed in a supine position for ultrasound imaging of the gastric antrum to check for contents (empty, clear liquid, or solid). The child will then be turned to the right lateral decubitus (RLD) position, and the gastric volume will be measured three times using cross-sectional area (CSA) and averaged using the Perlas equation. During the imaging, one image in the supine and RLD positions, along with one live clip in RLD.. The same process will be repeated during the end-op period. Post-surgery, the child will be monitored in the recovery ward for up to 6 hours. Any occurrence of postoperative nausea or vomiting will be treated with ondansetron, and the event will be documented. |