| CTRI Number |
CTRI/2024/08/072668 [Registered on: 19/08/2024] Trial Registered Prospectively |
| Last Modified On: |
18/08/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Follow Up Study |
| Study Design |
Other |
|
Public Title of Study
|
Assessment of abdominal contents in diabetic and non-diabetic patients using ultrasonography before surgery |
|
Scientific Title of Study
|
Assessment of gastric residual volume using ultrasonography in diabetic and non-diabetic patients undergoing elective surgery: an observational 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 |
Nijila K N |
| Designation |
Anaesthesia Resident |
| Affiliation |
Sardar Patel Medical College, Bikaner, Rajasthan |
| Address |
Department of Anaesthesia,
Sardar Patel Medical College
Bikaner
RAJASTHAN
334001
India |
| Phone |
6282885748 |
| Fax |
|
| Email |
knnijila@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Kiwi Mantan |
| Designation |
Associate Professor |
| Affiliation |
Sardar Patel Medical College, Bikaner, Rajasthan |
| Address |
Department of Anaesthesia,
Sardar Patel Medical College
Bikaner
RAJASTHAN
334001
India |
| Phone |
9929092702 |
| Fax |
|
| Email |
kiwivyas@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Kiwi Mantan |
| Designation |
Associate Professor |
| Affiliation |
Sardar Patel Medical College, Bikaner, Rajasthan |
| Address |
Department of Anaesthesia,
Sardar Patel Medical College
RAJASTHAN
334001
India |
| Phone |
9929092702 |
| Fax |
|
| Email |
kiwivyas@gmail.com |
|
|
Source of Monetary or Material Support
|
| Sardar Patel Medical College, Bikaner, Rajasthan, India - 334003 |
|
|
Primary Sponsor
|
| Name |
Sardar Patel Medical College, Bikaner, Rajasthan |
| Address |
Department of Anaesthesiology, Sardar Patel Medical College, Bikaner, Rajasthan |
| 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 |
| DrNijila K N |
Sardar Patel Medical College, Bikaner |
Department of Anaesthesia
Bikaner
RAJASTHAN |
6282885748
knnijila@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical and Research Board, Sardar Patel Medical College, Bikaner |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: E00-E89||Endocrine, nutritional and metabolic diseases, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
USG guided gastric residual volume calculation |
Gastric residual volume will be calculated using USG in diabetic patients undergoing elective surgery who have fasted for 6 hours for solids and 2 hours for clear fluids. |
| Comparator Agent |
USG guided gastric residual volume calculation |
Gastric residual volume will be calculated using USG in non-diabetic patients undergoing elective surgery who have fasted for 6 hours for solids and 2 hours for clear liquids. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Patients with age 18-65 years.
Patients belonging to ASA physical status I to III.
Patients with 6 hours fasting for solids and 2 hours fasting for liquids.
Patients with BMI 18-30. |
|
| ExclusionCriteria |
| Details |
Pregnant women.
Patients with morbid obesity.
Patients who are unable to lie on right lateral position.
Patients with history of upper GIT diseases or surgeries.
Patients who are on drugs that may delay gastric emptying.
Patients with hypothyroidism. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To assess the nature and volume of gastric content in fasting diabetic and non-diabetic patients posted for elective surgeries. |
After 6 hours fasting for solids and 2 hours fasting for liquids |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To correlate fasting gastric content and volume with age, BMI, duration and control of diabetes. |
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)
|
30/08/2024 |
| 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="6"
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
|
Our aim is to compare the gastric residual volume in diabetic and non-diabetic patients undergoing elective surgery using ultrasonography, who have fasted 6 hours for solids and 2 hours for clear liquids. This may help us to take extra measures in diabetic patients to prevent pulmonary aspiration of gastric contents, which is one of the most feared complication of anaesthesia. |