| CTRI Number |
CTRI/2024/03/064458 [Registered on: 19/03/2024] Trial Registered Prospectively |
| Last Modified On: |
13/03/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
prospective randomised, single blinded |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
comparison of contents and volume of stomach content in diabetic and non-diabetic patients before surgery |
|
Scientific Title of Study
|
To compare gastric content and volume in diabetic and non-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 Shashi Kiran |
| Designation |
Senior Professor |
| Affiliation |
Pt BD Sharma PGIMS, Rohtak |
| Address |
Department of Anaesthesiology and critical care, Pt BD Sharma PGIMS, Rohtak
Rohtak
HARYANA
124001
India |
| Phone |
9416763899 |
| Fax |
|
| Email |
drshashi64@rediffmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Rahul N |
| Designation |
Junior Resident |
| Affiliation |
Pt BD Sharma PGIMS, Rohtak |
| Address |
Department of Anaesthesiology and critical care, Pt BD Sharma PGIMS, Rohtak
Rohtak
HARYANA
124001
India |
| Phone |
7204099625 |
| Fax |
|
| Email |
rahuljune1997@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Rahul N |
| Designation |
Junior Resident |
| Affiliation |
Pt BD Sharma PGIMS, Rohtak |
| Address |
Department of Anaesthesiology and critical care, Pt BD Sharma PGIMS, Rohtak
Rohtak
HARYANA
124001
India |
| Phone |
7204099625 |
| Fax |
|
| Email |
rahuljune1997@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Anaesthesiology and critical care, Pt BD Sharma PGIMS, Rohtak |
|
|
Primary Sponsor
|
| Name |
Pt BD Sharma PGIMS, Rohtak |
| Address |
Department of Anaesthesiology and critical care, Pt BD Sharma PGIMS, Rohtak |
| 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 |
| Dr Rahul N |
Pt BD Sharma PGIMS Rohtak |
Department of Anaesthesiology and Critical Care, Pt BD Sharma PGIMS Rohtak Haryana
Rohtak
HARYANA |
7204099625
rahuljune1997@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Biomedical research ethics committee Pt. B.D. Sharma PGIMS/UHS, Rohtak |
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 |
| Comparator Agent |
Comparing Diabetic and non diabetic patients |
comparison of the gastric volume and content will be done in diabetic and non-diabetic patients |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
85.00 Year(s) |
| Gender |
Both |
| Details |
Patients of ASA grade (I - III) posted for elective surgery |
|
| ExclusionCriteria |
| Details |
Patients undergoing emergency surgeries, pregnancy, gastroesophageal reflux disease, having hiatus hernia, BMI more than 35, undergoing Gl surgery |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To assess qualitative information about gastric content and volume preoperatively in diabetic and nondiabetic patients preoperatively undergoing elective surgery |
8-12hrs after fasting |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To assess quantitative information about gastric content & volume preoperatively in diabetic & nondiabetic patients preoperatively undergoing elective surgery |
8-12hrs after fasting |
|
|
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)
|
15/04/2024 |
| 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="3"
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
|
The present observational study will be conducted in Department of Anaesthesia and critical care, PGIMS , Rohtak. Anteroposterior and Craniocaudal diameter will be calculated using ultrasound, Gastric volume will be calculated using standard formula. The gatsric content and volume will be compared in diabetic and non diabetic patients. Data will be compiled and analysed with appropriate statistical tests. |