| CTRI Number |
CTRI/2024/04/065719 [Registered on: 15/04/2024] Trial Registered Prospectively |
| Last Modified On: |
15/04/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
comparative study |
| Study Design |
Other |
|
Public Title of Study
|
To check the volume of stomach in non-diabetic and diabetic patients using ultrasound before undergoing surgery. |
|
Scientific Title of Study
|
Pre-operative sonographic assessment of fasting gastric volume among non-diabetic and diabetic patients undergoing 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 |
DR K VISHNU PRIYA |
| Designation |
POST GRADUATE |
| Affiliation |
DR B R AMBEDKAR MEDICAL COLLEGE AND HOSPITAL |
| Address |
DEPARTMENT OF ANAESTHESIOLOGY,DR B R AMBEDKAR MEDICAL COLLEGE AND HOSPITAL,K G HALLI,BENGALURU
Bangalore
KARNATAKA
560045
India |
| Phone |
7022997760 |
| Fax |
|
| Email |
priyakaushi123@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DR M SALIM IQBAL |
| Designation |
PROFESSOR |
| Affiliation |
DR B R AMBEDKAR MEDICAL COLLEGE AND HOSPITAL |
| Address |
DEPARTMENT OF ANAESTHESIOLOGY,DR B R AMBEDKAR MEDICAL COLLEGE AND HOSPITAL,K G HALLI,BENGALURU
Bangalore
KARNATAKA
560045
India |
| Phone |
9964651079 |
| Fax |
|
| Email |
drsalim_iqbal@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
DR M SALIM IQBAL |
| Designation |
PROFESSOR |
| Affiliation |
DR B R AMBEDKAR MEDICAL COLLEGE AND HOSPITAL |
| Address |
DEPARTMENT OF ANAESTHESIOLOGY,DR B R AMBEDKAR MEDICAL COLLEGE AND HOSPITAL,K G HALLI,BENGALURU
Bangalore
KARNATAKA
560045
India |
| Phone |
9964651079 |
| Fax |
|
| Email |
drsalim_iqbal@yahoo.com |
|
|
Source of Monetary or Material Support
|
| DR B R AMBEDKAR MEDICAL COLLEGE AND HOSPITAL,BENGALURU |
|
|
Primary Sponsor
|
| Name |
DR K VISHNU PRIYA |
| Address |
DEPARTMENT OF ANAESTHESIOLOGY,DR B R AMBEDKAR MEDICAL COLLEGE AND HOSPITAL,BENGALURU |
| 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 |
| DR K VISHNU PRIYA |
O T COMPLEX |
DR B R AMBEDKAR MEDICAL COLLEGE AND HOSPITAL,BENGALURU-560045
Bangalore
KARNATAKA |
7022997760
priyakaushi123@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTEE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: E08-E13||Diabetes mellitus, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
19.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
1.Patients posted for elective surgeries.
2.American Society of Anaesthesiolgists physical status(ASA-PS)I-III patients. |
|
| ExclusionCriteria |
| Details |
1.Patients posted for elective surgeries.
2.Hypothyroidism.
3.Gastrointestinal obstructive diseases, previous gastrointestinal surgeries.
4.Chronic kidney disease
5.Body mass index more than 30 kg per meter square.
6.Patients with in situ nasogastric tube. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To compare the mean antral cross-sectional area of stomach after 8 hour of fasting in non-diabetic and diabetic patients undergoing elective surgery. |
After confirming nil per oral status in pre operative room. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To assess the mean gastric volume per kilogram weight after 8 hour of fasting between the two study groups. |
After confirming nil per oral status of 8 hour. |
|
|
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)
|
06/05/2024 |
| 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="1"
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
|
Perioperative aspiration of gastric contents is a serious complication and is associated with high morbidity and mortality. Diabetic patients have delayed gastric emptying due to gastroparesis, predisposing them to increased risk of aspiration as compared to non-diabetic patients. Diabetic patients are more likely to experience gastroparesis brought on by autonomic dysfunction. Gastroparesis is a medical condition which is defined as delayed gastric emptying in absence of mechanical obstruction. Despite adherence to ISA perioperative fasting and feeding guidelines , devastating aspiration can happen because we cannot quantify or rule out dangerous gastric content before anesthesia. Measures such as prokinetic agents and antacid use and rapid sequence induction are sometimes used empirically.
Point of care ultrasonography can be used for gastric volume assessment. It is readily available, simple, non-invasive and easy to perform. Aim of the study is to assess the fasting gastric volume in non-diabetic compared with diabetic patients undergoing elective surgery to minimize the risk of regurgitation and aspiration.
|