| CTRI Number |
CTRI/2025/03/082518 [Registered on: 18/03/2025] Trial Registered Prospectively |
| Last Modified On: |
11/03/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Process of Care Changes |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Comparison Of Gastric Content In patients Fasting Vs patients given with Oral Rehydration Solution 2hours prior to surgery using Ultrasound machine placed on Stomach.
|
|
Scientific Title of Study
|
A Randomized Prospective Comparative Study Of Assessment Of Residual Gastric Volume By USG In Patients With Overnight Fasting Vs Administration Of Oral Re Hydration Solution 2 Hours Prior To The Surgery In A Tertiary Cancer Care Center |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Bharath B |
| Designation |
MD Student |
| Affiliation |
Kidwai Memorial Institute of Oncology , Bengaluru |
| Address |
Room no 105,OT complex building, Kidwai memorial institute of oncology, Dr M H Marigowda Road, Bengaluru
Bangalore
KARNATAKA
560029
India |
| Phone |
8553282568 |
| Fax |
|
| Email |
iambharathbharath@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Henjarappa K S |
| Designation |
Associate Professor |
| Affiliation |
Kidwai Institute of Oncology, Bengaluru |
| Address |
Room No 105, OT Complex Building, Ground Floor,
Kidwai Memorial Institute Of Oncology, Bengaluru
Bangalore
KARNATAKA
560029
India |
| Phone |
7019933746 |
| Fax |
|
| Email |
drhenjarappa@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Henjarappa K S |
| Designation |
Associate Professor |
| Affiliation |
Kidwai Institute of Oncology, Bengaluru |
| Address |
Room No 105, OT Complex Building, Ground Floor,
Kidwai Memorial Institute Of Oncology, Bengaluru
Bangalore
KARNATAKA
560029
India |
| Phone |
7019933746 |
| Fax |
|
| Email |
drhenjarappa@gmail.com |
|
|
Source of Monetary or Material Support
|
| Room no 105,OT complex building, Department of Anaesthesiology, Kidwai Memorial Institute of Oncology, Bangalore, India- 560029 |
|
|
Primary Sponsor
|
| Name |
Dr Bharath B |
| Address |
Room No 105 Department of Anaesthesiology , OT complex building , Kidwai Memorial institute of Oncology, Banglore , india -560029 |
| Type of Sponsor |
Other [Self] |
|
|
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 Bharath B |
Kidwai memorial institute of Oncology |
Department of Anesthesiology and pain Relief, OT Block, Kidwai Memorial Institute Of Oncology, Dr M H Marigowda Road Bengaluru 560029
Bangalore
KARNATAKA |
8553282568
iambharathbharath@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Medical Ethics Committe, Kidwai Memorial Institute Of Oncology |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: C40-C41||Malignant neoplasms of bone and articular cartilage, (2) ICD-10 Condition: C00-C14||Malignant neoplasms of lip, oral cavity and pharynx, (3) ICD-10 Condition: C30-C39||Malignant neoplasms of respiratory and intrathoracic organs, (4) ICD-10 Condition: C43-C44||Melanoma and other malignant neoplasms of skin, (5) ICD-10 Condition: C45-C49||Malignant neoplasms of mesothelial and soft tissue, (6) ICD-10 Condition: C50-C50||Malignant neoplasms of breast, (7) ICD-10 Condition: C51-C58||Malignant neoplasms of female genital organs, (8) ICD-10 Condition: C60-C63||Malignant neoplasms of male genital organs, (9) ICD-10 Condition: C64-C68||Malignant neoplasms of urinary tract, (10) ICD-10 Condition: C73-C75||Malignant neoplasms of thyroid and other endocrine glands, (11) ICD-10 Condition: C7A-C7A||Malignant neuroendocrine tumors, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Administration of Oral rehydration solution 200ml 2 hours prior to the Surgery |
Administration of Oral rehydration solution 2 hours prior to the surgery and assessment of residual gastric volume after 2 hours i.e at the time of taking up to surgery by Ultrasound examination on the gastric antrum and calculate the risk of aspiration using Anahi Perlas formula |
| Comparator Agent |
Nil per oral patients overnight- 8 hours for solids |
Assessment of gastric volume for patients with nil per oral overnight using Ultrasound on gastric antrum and using Anahi perlas formula and assessing the risk of aspiration. |
|
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Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1.Patients undergoing elective Surgery
2.age between 18 to 60 years
3.Patient who can provide consent
4.Accepted under ASA grade 1 and ASA grade 2 |
|
| ExclusionCriteria |
| Details |
Patient refusal to the consent, patients with gastroesophageal reflux disease, patients accepted under ASA grade 3 and ASA grade 4, patients with uncontrolled diabetes mellitus, patients with GI obstruction. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To assess residual gastric volume by USG after administration of oral rehydration solution 2 hours prior to the surgery |
2 hours prior to the surgery |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| nil |
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)
|
22/03/2025 |
| 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="2"
Months="0"
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
|
A
randomized prospective comparative study of assessment of residual gastric
volume by USG in patients with overnight fasting vs administration of oral
rehydration solution 2 hours prior to the surgery in a tertiary cancer care
center. Patient will be examined
in a safe environment using Ultrasonography machine Fujifilm Sonosite attached to a curvilinear probe
with 3-5 MHz frequency. The gastric antrum will be visualized by placing the
probe in sagittal or parasagittal plane. The
AP[anteroposterior diameter] and CC[craniocaudal diameter] (in cm)measurements
will be taken in supine position and if residual gastric volume is noted,
patient will be positioned to right lateral position and the measurements will
be taken. We study residual gastric
volume by ultrasonography as outcome of the study |