| CTRI Number |
CTRI/2026/02/104127 [Registered on: 17/02/2026] Trial Registered Prospectively |
| Last Modified On: |
11/02/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cohort Study |
| Study Design |
Other |
|
Public Title of Study
|
A prospective study to compare preoperative fasting volume of gastric contents by using ultrasonography in diabetic and non diabetic patients posted for elective surgery. |
|
Scientific Title of Study
|
A prospective study to compare preoperative fasting volume of gastric contents by using ultrasonography in diabetic and non diabetic patients posted for elective 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 |
Swati Deka |
| Designation |
Junior Resident |
| Affiliation |
Kokilaben Dhirubhai Ambani Hospital and Medical Research Institute |
| Address |
Kokilaben Dhirubhai Ambani Hospital and Medical Research Institute Rao Saheb Achutrao Patwardhan Marg Four Bunglows Andheri West Mumbai Maharashtra 400053
Kokilaben Dhirubhai Ambani Hospital and Medical Research Institute Rao Saheb Achutrao Patwardhan Marg Four Bunglows Andheri West Mumbai Maharashtra 400053
Mumbai
MAHARASHTRA
400053
India |
| Phone |
7896023367 |
| Fax |
|
| Email |
swatideka11@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Hemlata Kapoor |
| Designation |
Senior Consultant |
| Affiliation |
Kokilaben Dhirubhai Ambani Hospital and Medical Research Institute |
| Address |
Kokilaben Dhirubhai Ambani Hospital and Medical Research Institute Rao Saheb Achutrao Patwardhan Marg Four Bunglows Andheri West Mumbai Maharashtra 400053
Kokilaben Dhirubhai Ambani Hospital and Medical Research Institute Rao Saheb Achutrao Patwardhan Marg Four Bunglows Andheri West Mumbai Maharashtra 400053
Mumbai
MAHARASHTRA
400053
India |
| Phone |
7896023367 |
| Fax |
|
| Email |
HEMA.KAPOOR@kokilabenhospitals.com |
|
Details of Contact Person
Public Query
|
| Name |
Swati Deka |
| Designation |
DNB Resident |
| Affiliation |
Kokilaben Dhirubhai Ambani Hospital and Medical Research Institute |
| Address |
Kokilaben Dhirubhai Ambani Hospital and Medical Research Institute Rao Saheb Achutrao Patwardhan Marg Four Bunglows Andheri West Mumbai Maharashtra 400053
Kokilaben Dhirubhai Ambani Hospital and Medical Research Institute Rao Saheb Achutrao Patwardhan Marg Four Bunglows Andheri West Mumbai Maharashtra 400053
Mumbai
MAHARASHTRA
400053
India |
| Phone |
7896023367 |
| Fax |
|
| Email |
swatideka11@gmail.com |
|
|
Source of Monetary or Material Support
|
| Kokilaben Dhirubhai Ambani Hospital and Medical Research Institute |
|
|
Primary Sponsor
|
| Name |
Kokilaben Dhirubhai Ambani Hospital and medical research Institute |
| Address |
Kokilaben Dhirubhai Ambani Hospital and Medical Research Institute Rao Saheb Achutrao Patwardhan Marg Four Bunglows, Andheri West Mumbai Maharashtra 400053 |
| 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 Swati Deka |
Kokilaben Dhirubhai Ambani Hospital |
2nd floor IEC Kokilaben Dhirubhai Ambani Hospital and Medical Research Institute Rao Saheb Achutrao Patwardhan Marg Four Bunglows, Andheri West Mumbai Maharashtra 400053
Mumbai (Suburban)
MAHARASHTRA |
07896023367
swatideka11@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| KDAH-IEC |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: E119||Type 2 diabetes mellitus without complications, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
1 all patients of age group 18 years and above
2 Physical status ASA I II
3 Patients who have given voluntary written informed consent
4 All patients posted for elective surgeries |
|
| ExclusionCriteria |
| Details |
1 Patients less than 18 years and more than 80 years
2 ASA III IV
3 Gastro intestinal malignancy
4 Chronic renal disease
5 Connective tissue disease affecting gut motility
6 Obese patient with BMI more than 30
7 Pregnant women
8 Prior abdominal and esophageal surgery |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Due to delayed gastric emptying seen in diabetic patients the risk of aspiration of gastric contents increases after adequate fasting of 8 hours as compared to non diabetics. |
before the patient is shifted inside the OT for surgery |
|
|
Secondary Outcome
|
|
|
Target Sample Size
|
Total Sample Size="80"
Sample Size from India="80"
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)
|
23/02/2026 |
| 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="1"
Months="6"
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
|
Perioperative aspiration of gastric contents can cause significant morbidity and mortality The lower esophageal tone and upper airway reflexes decrease during general anaesthesia making the patient more susceptible to aspiration Diabetic patients have delayed gastric emptying predisposing them to increased risk of aspiration As per practice guidelines of American Society of Anaesthesiologists alight meal can be ingested for upto 6 hours and a heavy meal upto8 hours before anaesthesia Point of care gastric ultrasonography prior to induction of anaesthesia can play an important role in assessment of gastric contents Gastric ultrasound examination can identify the nature of the gastric contents whether clear fluids or solids and can also quantify the same In this study we use the point of care ultrasonography to compare the gastric volume in diabetic and non diabetic patients undergoing elective surgery who have been starving for at least 8 hours |