| CTRI Number |
CTRI/2024/11/077330 [Registered on: 25/11/2024] Trial Registered Prospectively |
| Last Modified On: |
19/08/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
A study to compare the difference between fasted gastric volumes in diabetic and non diabetic patients scheduled for elective surgery |
|
Scientific Title of Study
|
Comparision of Ultrasound Guided Fasted Gastric Residual Volume between Diabetic and Non-Diabetic Patients Scheduled for Elective Surgeries- An Analytical 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 |
Dungala Sampreeti |
| Designation |
Junior Resident |
| Affiliation |
NKP salve institute of medical sciences and research centre and Lata Mangeshkar Hospital |
| Address |
Department of Anaesthesiology, NKP Salve institute of Medical Sciences and Research Centre and Lata Mangeshkar Hospital, Digdoh Hills, Hingna Road, Nagpur
Nagpur
MAHARASHTRA
440019
India |
| Phone |
9550097711 |
| Fax |
|
| Email |
sampreethi1093@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Ketaki Marodkar |
| Designation |
Professor, Department of Anaesthesiology |
| Affiliation |
NKP salve institute of medical sciences and research centre and Lata Mangeshkar Hospital |
| Address |
Department of Anaesthesiology, NKP Salve institute of Medical Sciences and Research Centre and Lata Mangeshkar Hospital, Digdoh Hills, Hingna Road, Nagpur
Nagpur
MAHARASHTRA
440019
India |
| Phone |
7498515646 |
| Fax |
|
| Email |
drketaki_didolkar@yahoo.co.in |
|
Details of Contact Person
Public Query
|
| Name |
Dungala Sampreeti |
| Designation |
Junior Resident |
| Affiliation |
NKP Salve Institute of Medical Sciences and Research Centre and Lata Mangeshkar Hospital |
| Address |
Department of Anaesthesiology, NKP Salve institute of Medical Sciences and Research Centre and Lata Mangeshkar Hospital, Digdoh Hills, Hingna Road, Nagpur
Nagpur
MAHARASHTRA
440019
India |
| Phone |
9550097711 |
| Fax |
|
| Email |
sampreethi1093@gmail.com |
|
|
Source of Monetary or Material Support
|
| NKP Salve institute of Medical Sciences and Research Centre and Lata Mangeshkar Hospital |
|
|
Primary Sponsor
|
| Name |
NKP Salve Institute of Medical Sciences and Research Centre and Lata Mangeshkar Hospital |
| Address |
Department of Anaesthesiology, NKP Salve institute of Medical Sciences and Research Centre and Lata Mangeshkar Hospital, Digdoh Hills, Hingna Road, Nagpur |
| 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 |
| Dungala Sampreeti |
NKP Salve Institute of Medical Sciences and Research Centre and Lata Mangeshkar Hospital |
Department of Anaesthesiology, NKP Salve institute of Medical Sciences and Research Centre and Lata Mangeshkar Hospital, Digdoh Hills, Hingna Road, Nagpur
Nagpur
MAHARASHTRA |
9550097711
sampreethi1093@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, N.K.P Salve Institute of Medical Sciences and Research Centre and Lata Mangeshkar Hospital |
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 |
| Intervention |
Nil |
Nil |
| Comparator Agent |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
INCLUSION CRITERIA FOR DIABETIC PATIENTS:
1. American Society of Anesthesiology (ASA) physical status II, III scheduled for elective surgery.
2. Patients of both sexes aged more than 18 years.
3. Patients with diabetic history of more than 5 years .
4. Body mass index [BMI] less than 35 kg/m2
INCLUSION CRITERIA FOR NON- DIABETIC PATIENTS
1. American Society of Anesthesiology (ASA) physical status I, II, III scheduled for elective surgery
2. Patients of both sexes aged more than 18 years .
3. Body mass index [BMI] less than 35 kg/m2 |
|
| ExclusionCriteria |
| Details |
1. Patient on medication of upper gastrointestinal symptoms .
2. Gastroesophageal reflux disease .
3. Previous gastrointestinal surgery .
4. Recent abdominal trauma .
5. Chronic kidney disease .
6. Pregnant patients . |
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To compare fasted gastric residual volume between diabetic and non- diabetic patients scheduled for elective surgeries by estimating antral cross sectional area by using ultrasound. |
This will be done preoperatively |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To find association between ultrasound-guided fasted gastric residual volume and duration of diabetes in patients scheduled for elective surgeries. |
This will be done preoperatively |
| To find association between ultrasound-guided fasted gastric residual volume and body mass index (BMI) in patients scheduled for elective surgery. |
This will be done preoperatively |
|
|
Target Sample Size
|
Total Sample Size="112"
Sample Size from India="112"
Final Enrollment numbers achieved (Total)= "112"
Final Enrollment numbers achieved (India)="112" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
04/12/2024 |
| Date of Study Completion (India) |
30/06/2025 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
30/06/2025 |
|
Estimated Duration of Trial
|
Years="1"
Months="6"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
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
|
Aspiration of gastric contents during perioperative period is one of the most feared complications with high fatality rate in anaesthesia. • Overall incidence of gastric content aspiration ranges between <0.1% and 19% and [1] ,[2] aspiration pneumonia accounts for 9% of all anaesthesia related mortality. • Patients with long-standing diabetes have a higher incidence of autonomic dysfunction causing gastropathy and delayed gastric emptying which predisposes [3] them to increased risk of aspiration, than non-diabetic fasted population. • American Society of Anesthesiologists (ASA) in 2017 came up with the conclusion that patients with concomitant diseases like obesity , diabetes mellitus, obstetric patients, critically ill patients have prolonged stomach emptying time, so it requires increasing the standard nil per oral (NPO) • Gastric ultrasound (GUS) is an emerging point of care diagnostic tool to examine stomach contents, determine the gastric residual volume and pulmonary aspiration risk at the bedside. • This is also helpful in guiding the anesthesiologist in airway management in the acute care setting , when nil per oral(NPO) status is doubtful or unknown or patient has conditions or comorbidities like diabetes mellitus(DM) that effect gastric emptying. • Studies have shown an association of gastroparesis with duration of diabetes mellitus(DM) and other factors such as age and body mass index (BMI). [2] . • Therefore we planned this analytical cross sectional study with an aim to compare gastric volume between diabetic and non-diabetic patients using gastric ultrasound in fasted state |