| CTRI Number |
CTRI/2025/07/090816 [Registered on: 14/07/2025] Trial Registered Prospectively |
| Last Modified On: |
12/07/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Using ultrasound to check how much liquid is left in the stomach before giving general anesthesia : comparing patients who fasted for a long time with those who had clear liquids 2 or 4 hours before |
|
Scientific Title of Study
|
Point of care ultrasound to estimate of gastric residual volume before
general anaesthesia after prolonged fasting and 4hr and 2 hours fasting for clear liquids - an observational cross sectional study |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr MD SARWAR |
| Designation |
Junior resident |
| Affiliation |
Rajendra institute of medical sciences |
| Address |
Department of anesthesiology RIMS Bariatu Ranchi
Ranchi
JHARKHAND
834009
India |
| Phone |
8851768337 |
| Fax |
|
| Email |
Md.sarwar727@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Prof Dr Shio Priye |
| Designation |
Professor |
| Affiliation |
Rajendra institute of medical sciences |
| Address |
HOD, department of anaesthesiology,
Bariatu,
Ranchi
Ranchi
JHARKHAND
834009
India |
| Phone |
9986743162 |
| Fax |
|
| Email |
Shiopriye@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Saurabh Suman |
| Designation |
Assistant professor |
| Affiliation |
Rajendra institute of medical sciences |
| Address |
Department of anaesthesiology, RIMS ranchi
Ranchi
JHARKHAND
834009
India |
| Phone |
7079893536 |
| Fax |
|
| Email |
Saurabh31.7.dmch@gmail.com |
|
|
Source of Monetary or Material Support
|
| Rajendra institute of medical sciences
Bariatu, Ranchi, Jharkhand 834009 |
|
|
Primary Sponsor
|
| Name |
Rajendra institute of medical sciences |
| Address |
Department of anaesthesiology, RIMS, Bariatu, Ranchi, Jharkhand 834009 |
| 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 Md Sarwar |
Rajendra Institute of medical sciences |
Department of anaesthesiology
Department of general surgery operation theatre
Department of neurosurgery operation theatre
Department of ENT operation theatre
RIMS, Bariatu Ranchi
Ranchi
JHARKHAND |
8851768337
Md.sarwar727@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethics committee, RIMS Ranchi |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K801||Calculus of gallbladder with othercholecystitis, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Ultrasound of abdomen to look for gastric residual volume |
200 mL of water is given orally before surgery conducted under general anaesthesia then gastric residual volume is estimated using ultrasound. Each intervention takes 15min. |
| Comparator Agent |
Ultrasound of abdomen to look for gastric residual volume after ingestion of 200ml of water before 2 hrs |
200 mL of water is given orally 2hrs before surgery conducted under general anaesthesia then gastric residual volume is estimated using ultrasound. Each intervention takes 15min. |
| Comparator Agent |
Ultrasound of abdomen to look for gastric residual volume after ingestion of 200ml of water before 4 hrs |
200 mL of water is given orally 4 hrs before surgery conducted under general anaesthesia then gastric residual volume is estimated using ultrasound. Each intervention takes 15min. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1. ASA Grade 1-2
2. Patient of age group 18-60yrs posted for elective surgery under GA
3. BMI less than 35 |
|
| ExclusionCriteria |
| Details |
1. ASA Grade 3-5
2. Patient who refuses to participate in the study
3. Patientshaving history of GI surgery
4. Patients having history of GI disease
5. Patients who are bed ridden
6. Diabetic patients |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Assess the gastric residual volume in 4 hrs and 2 hrs fasting for clear liquids |
Before induction of general anaesthesia |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
a. Compare risk of aspiration
b. Look for post operative nausea omitting
c. Assess the need of Ryles tube insertion |
During induction of general anaesthesia & 6 hrs post operatively |
|
|
Target Sample Size
|
Total Sample Size="180"
Sample Size from India="180"
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)
|
25/07/2025 |
| 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="8"
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
|
The presence of gastric contents increases the risk of aspiration. As a result, practiceguidelines for preoperative fasting were developed to provide adequate time for gastric emptying in patients undergoing surgery. Point-of-care gastric ultrasound preoperative gastric ultrasound represents a feasible option that can be incorporated into standard anesthesia practice to assess the gastric antrum and, thereby, gastric volume owing to its cost-effectiveness and ease of performing at the bedside. |