| CTRI Number |
CTRI/2025/09/095047 [Registered on: 18/09/2025] Trial Registered Prospectively |
| Last Modified On: |
17/09/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Medical Device |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
To compare the amount of stomach content in patients who have been fasting for 8hrs and those who have taken 200ml clear fluids 2hrs prior surgery |
|
Scientific Title of Study
|
QUALITATIVE AND QUANTITATIVE
ESTIMATION OF EFFECT OF CLEAR FLUIDS
ON
GASTRIC VOLUME USING
ULTRASONOGRAPHY IN A TERTIARY CARE
CENTRE A COMPARITIVE 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 Mangala C Patil |
| Designation |
Junior Resident |
| Affiliation |
Sapthagiri Institute Of Medical Sciences And Research Centre |
| Address |
Anesthesia Department, Ground Floor, Sapthagiri Institute of Medical
Sciences and Research Centre, Navy Layout, Hesaraghatta Main
Road, Chikkabanavara, Bangalore,
Bangalore
KARNATAKA
560090
India |
| Phone |
8971851827 |
| Fax |
|
| Email |
p.mangala75@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Nikila D G |
| Designation |
Associate Professor |
| Affiliation |
Sapthagiri Institute Of Medical Sciences And Research Centre |
| Address |
Anesthesia Department, Ground Floor, Sapthagiri Institute of Medical
Sciences and Research Centre, Navy Layout, Hesaraghatta Main
Road, Chikkabanavara, Bangalore,
Bangalore
KARNATAKA
560090
India |
| Phone |
9535243669 |
| Fax |
|
| Email |
nikiladg@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Nikila D G |
| Designation |
Associate Professor |
| Affiliation |
Sapthagiri Institute Of Medical Sciences And Research Centre |
| Address |
Anesthesia Department, Ground Floor, Sapthagiri Institute of Medical
Sciences and Research Centre, Navy Layout, Hesaraghatta Main
Road, Chikkabanavara, Bangalore,
Bangalore
KARNATAKA
560090
India |
| Phone |
9535243669 |
| Fax |
|
| Email |
nikiladg@gmail.com |
|
|
Source of Monetary or Material Support
|
| Sapthagiri Institute of Medical Sciences and Research Centre Department of Anasthesiology Ground Floor OT Complex Navya Layout Hesarghatta road Chikkabanavara Banglore Karnataka 560090 |
|
|
Primary Sponsor
|
| Name |
Sapthagiri Institute of Medical Sciences and Research Centre |
| Address |
Navya layout Hesarghatta road Chikkabanavara Banglore Karnataka 560090 |
| 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 Nikila D G |
Sapthagiri Institute of Medical Sciences and Research Centre |
Department of
Anaesthesiology
Ground Floor OT
Complex, #15
Hesarghatta Main
Road, Chikkabanavara
Bangalore
KARNATAKA
Bangalore
KARNATAKA |
9535243669
nikiladg@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Sapthagiri Institute of Medical Sciences and Research Centre |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: 4||Measurement and Monitoring, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Group A patients |
patients fasting for 8hrs ultrasonography of the stomach done to look for gastric volume before surgery |
| Comparator Agent |
Group B patients |
200ml of water given to patients 2hrs prior surgery later ultrasonography of the stomach done to look for gastric volume before surgery |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
a)BMI between 18-28kg/m2
b)ASA physical status – I and II
c)Patient willing to give informed consent.
d)Patients posted for elective surgery
|
|
| ExclusionCriteria |
| Details |
a)Patients undergoing GI surgeries.
b)Patients with diabetes mellitus,CKD, gastroesophageal reflux,pregnancy,hiatal hernia, gastric tumors.
c)Medications affecting gastric emptying.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To estimate and compare gastric volume in patients who have consumed 200ml of clear fluids 2hrs prior to surgery, after 8hrs of fasting, to those who have not consumed using ultrasonography. |
2hr prior to surgery |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| nil |
nil |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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)
|
28/09/2025 |
| 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="3"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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
|
To estimate and compare gastric volume in patients who have consumed 200ml of clear fluids 2hrs prior to surgery, after 8hrs of fasting, to those who have not consumed using ultrasonography. We are trying to see in our study of there is any residual volume of water present which could be high risk for aspiration |