| CTRI Number |
CTRI/2025/02/080843 [Registered on: 18/02/2025] Trial Registered Prospectively |
| Last Modified On: |
09/02/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
To find out relation between preoperative fasting duration and gastric volume using ultrasound machine in patients undergoing elective surgery. |
|
Scientific Title of Study
|
A study to evaluate actual preoperative fasting duration and its correlation with gastric volume as assessed by ultrasonography |
| 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 Susheela Taxak |
| Designation |
Senior Professor |
| Affiliation |
Pt.B.D.Sharma PGIMS Rohtak |
| Address |
Department of Anaesthesiology and critical care,Pt.B.D.Sharma
PGIMS,Rohtak
Department of Anaesthesiology and critical care,Pt.B.D.Sharma
PGIMS,Rohtak
Rohtak
HARYANA
124001
India |
| Phone |
9896067416 |
| Fax |
|
| Email |
susheelataxak@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Preeti |
| Designation |
Junior Resident |
| Affiliation |
Pt.B.D.Sharma PGIMS Rohtak |
| Address |
Department of Anaesthesiology and critical care,Pt.B.D.Sharma
PGIMS,Rohtak
Department of Anaesthesiology and critical care,Pt.B.D.Sharma
PGIMS,Rohtak
Rohtak
HARYANA
124001
India |
| Phone |
9992092678 |
| Fax |
|
| Email |
Preetiyadav4474@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Preeti |
| Designation |
Junior Resident |
| Affiliation |
Pt.B.D.Sharma PGIMS Rohtak |
| Address |
Department of Anaesthesiology and critical care,Pt.B.D.Sharma
PGIMS,Rohtak
Department of Anaesthesiology and critical care,Pt.B.D.Sharma
PGIMS,Rohtak
HARYANA
124001
India |
| Phone |
9992092678 |
| Fax |
|
| Email |
Preetiyadav4474@gmail.com |
|
|
Source of Monetary or Material Support
|
| Institutional, Pt B D Sharma University of Health Science PGIMS Rohtak Haryana |
|
|
Primary Sponsor
|
| Name |
Pt B D Sharma University of Health Science PGIMS Rohtak Haryana |
| Address |
Pt B D Sharma University of Health Science PGIMS Rohtak,124001, Haryana |
| 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 Preeti |
Pt B D Sharma, PGIMS, Rohtak |
Resident room,Department of Anaesthesiologist and critical care, PGIMS
Rohtak
HARYANA |
9992092678
preetiyadav4474@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 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
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Patients belonging to American Society Of Anaesthesiologist Physical status I,II Scheduled for elective surgery |
|
| ExclusionCriteria |
| Details |
Refusal to consent
Chronic hepatic and renal disease
Previous history of esophageal and gastric surgery
ASA grade III or more
Esophageal reflux disorder
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Assessed fasting time in patient posted for elective surgery |
Assessed fasting time in patient posted for elective surgery |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Assesses qualitative and quantitative information about gastric volume and gastric content. |
Patient discomfort measured using thirst score and hunger score. |
|
|
Target Sample Size
|
Total Sample Size="300"
Sample Size from India="300"
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)
|
10/03/2025 |
| 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="1"
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
|
This study aim to evaluate preoperative fasting and its correlation with gastric volume and gastric content using ultrasound . This study include 300 patient of either sex, age 18 to 60 years belonging to ASA I and II scheduled for elective surgery. Gasric volume and gastic content are measured using Ultrasonography in right lateral decubitus and semi sitting position And patient discomfort is measured using thirst score and hunger score. |