| CTRI Number |
CTRI/2025/07/091295 [Registered on: 21/07/2025] Trial Registered Prospectively |
| Last Modified On: |
18/07/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Assessment of Stomach Emptying after Energy Drink Intake Before Gallbladder Surgery Using Bedside Ultrasound in adults with gallstone disease |
|
Scientific Title of Study
|
Evaluation Of Gastric Residual Volume Emptying time following Carbohydrate Drink Intake Using Ultrasonography in Adult Patients Undergoing Laparoscopic Cholecystectomy - An Observational Study |
| 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 Ujjawal Rathore |
| Designation |
Academic Junior Reisdent Anaesthesiology |
| Affiliation |
AIIMS Guwahati |
| Address |
PG Hostel AIIMS Guwahati Silbharal Changsari Assam 781101
Kamrup
ASSAM
781101
India |
| Phone |
7376889960 |
| Fax |
|
| Email |
Ujjawalrathore29@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Aspari Mahammad Azeez |
| Designation |
Assistant professor |
| Affiliation |
AIIMS Guwahati |
| Address |
2052,2nd floor, OPD BUILDING, AIIMS Guwahati, Silbharal Changsari, Guwahati, Assam
Kamrup
ASSAM
781101
India |
| Phone |
8427693477 |
| Fax |
|
| Email |
aspariazeez@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Aspari Mahammad Azeez |
| Designation |
Assistant professor |
| Affiliation |
AIIMS Guwahati |
| Address |
2052,2nd floor, OPD BUILDING, AIIMS Guwahati, Silbharal Changsari, Guwahati, Assam
Kamrup
ASSAM
781101
India |
| Phone |
8427693477 |
| Fax |
|
| Email |
aspariazeez@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
AIIMS Guwahati |
| Address |
Silbharal Changsari, Guwahati, Assam 781101 |
| Type of Sponsor |
Research institution and hospital |
|
|
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 Ujjawal Rathore |
All India Institute of Medical Sciences Guwahati |
Room no 2052, Department of Anaesthesiology, Critical Care and Pain Medicine, 2nd floor, OPD building
Kamrup
ASSAM |
7376889960
Ujjawalrathore29@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| IEC, AIIMS Guwahati |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K80||Cholelithiasis, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1. Cholelithiasis Patients Scheduled for Laparoscopic Cholecystectomy
2. ASA PS I/II
3. 18-65 years old
4. Fasted Patients 8hrs for solids and 2 hrs for clear liquids.
|
|
| ExclusionCriteria |
| Details |
1. Patients with known gastric pathologies
2. Uncontrolled Diabetes Mellitus
3. Refusal to consent
4. Previous history of surgeries on the oesophagus or stomach
5. Pregnant patients
6. Obese patients with a BMI more than 30 kg per sq m
7. Patients who cannot lie down in the right lateral decubitus position.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Quantify absorption rate (time to Gastric Residual Volume less than 1.5 mL per kg or Perlas Grade 0 and 1) following complex carbohydrate ingestion |
T0 As soon as the patient is shifted to the preoperative area
T1 immediately after ingesting a Complex Carbohydrate Drink
T2 to Tx at subsequent intervals until the Gastric Residual Volume reaches less than 1.5ml per kg.
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| 1. To compare the Gastric Antral Cross sectional area in Supine and RLD positions |
T0 As soon as the patient is shifted to the preoperative area
T1 immediately after ingesting a Complex Carbohydrate Drink
T2 to Tx at subsequent intervals until the Gastric Residual Volume reaches less than 1.5ml per kg. |
| 2. To calculate GRV per kg and GRV per BSA |
T0 As soon as the patient is shifted to the preoperative area
T1 immediately after ingesting a Complex Carbohydrate Drink
T2 to Tx at subsequent intervals until the Gastric Residual Volume reaches less than 1.5ml per kg. |
| To assess Perlas Grade Distribution, hunger or thirst or satisfaction (NRS scale), and postoperative symptoms (nausea and vomiting) among the cohort |
T0 As soon as the patient is shifted to the preoperative area
T1 immediately after ingesting a Complex Carbohydrate Drink
T2 to Tx at subsequent intervals until the Gastric Residual Volume reaches less than 1.5ml per kg. |
|
|
Target Sample Size
|
Total Sample Size="55"
Sample Size from India="55"
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)
|
30/07/2025 |
| 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="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
|
This observational study aims to evaluate the gastric emptying time of a commercially available complex carbohydrate drink in adult patients undergoing elective laparoscopic cholecystectomy using point-of-care ultrasonography. Conducted at AIIMS Guwahati, the study will recruit 55 patients aged 18 to 65 years (ASA I or II) and assess gastric residual volume (GRV) at serial time intervals after ingestion of 296 mL of the drink, until a safe threshold (GRV less than 1.5 mL per kg or Perlas Grade 0 or 1) is reached. The study will also analyse gastric antral cross-sectional area (CSA) in different positions, and track postoperative symptoms like nausea and vomiting. The findings aim to determine whether current ERAS guidelines on preoperative carbohydrate loading are appropriate for Indian patients, especially those with potential for delayed gastric emptying due to underlying metabolic or gallbladder-related factors.
|