| CTRI Number |
CTRI/2025/07/091410 [Registered on: 22/07/2025] Trial Registered Prospectively |
| Last Modified On: |
22/07/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [carbohydrate rich drink] |
| Study Design |
Other |
|
Public Title of Study
|
Correlation of Ultrasonographically measured Stomach Residual Volume with Body Mass Index after Carbohydrate drink given 2 hours before surgery |
|
Scientific Title of Study
|
Correlation of Ultrasonically measured Gastric Residual Volume with Body Mass Index after Preoperative Carbohydrate- rich Drink |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Isha yadav |
| Designation |
Assistant professor |
| Affiliation |
UCMS and GTB Hospital |
| Address |
Department of Anaesthesiology and critical care,UCMS and GTB Hospital,Dilshad Garden ,Shahdara
East Delhi
110095
india
New Delhi
DELHI
110095
India |
| Phone |
7042300316 |
| Fax |
|
| Email |
ishayada@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Isha Yadav |
| Designation |
Assistant professor |
| Affiliation |
UCMS and GTB Hospital |
| Address |
department of Anaesthesiology and critical care,UCMS and GTB Hospital,Dilshad Garden ,Shahdara
East Delhi
110095
india
DELHI
110095
India |
| Phone |
7042300316 |
| Fax |
|
| Email |
ishayada@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Shreya garg |
| Designation |
postgraduate student |
| Affiliation |
UCMS and GTB Hospital |
| Address |
Department of Anaesthesiology and critical care,UCMS and GTB Hospital,Dilshad Garden,Shahdara
East Delhi
110095
india
New Delhi
DELHI
110095
India |
| Phone |
8168935805 |
| Fax |
|
| Email |
shreyagarg2564@gmail.com |
|
|
Source of Monetary or Material Support
|
| University college of medical sciences and GTB Hospital |
|
|
Primary Sponsor
|
| Name |
University college of medical sciences and GTB Hospital |
| Address |
Dilshad garden, Shahdara |
| 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 |
| shreya garg |
university college of medical sciences and GTB Hospital |
Anaesthesia office room,2nd floor,OT Block ,department of Anaesthesia and critical care, university college of medical sciences and GTB Hospital,dIlshad garden,shahdara
New Delhi
DELHI |
8168935805
shreyagarg2564@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITEE -HUMAN RESEARCH ,UNIVERSITY COLLEGE OF MEDICAL SCIENCES,UNIVERSITY OF DELHI,DELHI |
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 |
CARBOHYDRATE RICH PREOPERATIVE DRINK |
GIVEN 2 HOURS PRIOR TO THE SURGERY |
|
|
Inclusion Criteria
|
| Age From |
18.00 Day(s) |
| Age To |
65.00 Day(s) |
| Gender |
Both |
| Details |
Consenting ASA grade I,II,III patients aged 18-65 years with BMI ranging from 18.5 -35 kg/m2 undergoing elective surgery willing to give consent for antral scan |
|
| ExclusionCriteria |
| Details |
1.patients with a history of gastrointestinal surgery, evidence of gastroesophageal reflux, gastrointestinal obstruction, hiatal hernia or related medical history
2.patients with diabetes
3.parturients |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To evaluate correlation of POCUS derived RGV with patients BMI,2 hours after standardised preoperative oral carbohydrate rich drink |
2 hours after standardised preoperative oral carbohydrate rich drink |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| to evaluate correlation of POCUS derived RGV with patients BMI |
2 HOURS after preoperative carbohydrate rich drink |
|
|
Target Sample Size
|
Total Sample Size="75"
Sample Size from India="75"
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)
|
05/08/2025 |
| 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="4"
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
|
my aim is to To evaluate the correlation of POCUS derived residual gastric volume with BMI after a preoperative oral carbohydrate rich fluid. Primary Objectives are to evaluate correlation of POCUS derived RGV with the patients BMI 2 hours after a standardized preoperative oral carbohydrate rich drink
Written informed consent will be taken and the study is Prospective Interventional Pilot Study with Patients in the age group of 18 to 65 kg with ASA 1,2,3 having BMI 18.5 to 35 kg per m2 for elective surgery will be taken ,Patients with prior gastrointestinal surgery and parturients will be excluded from the present study. Gastric antrum will be measured using POCUS in the immediate preoperative period, and 2 hours after 50 grams of Energizer,Neon, the carbohydrate drink in the volume of 296 ml and antral CSA for assessing the RGV will be done. For antral CSA assessment, two vertical diameters are measured: the longest diameter and shortest diameter The CSA of the gastric antrum is calculated using the formula CSA gastric residual volume will be calculated, which will be subsequently correlated with Body Mass Index. In case the RGV is found to be more than 1.5 ml per kg, 2 hours after the oral carbohydrate rich drink Energizer a repeat scan will be performed every 30 minutes till the volume is found to be in safe limits of less than 1.5 ml per kg before anesthetizing the patient.
|