| CTRI Number |
CTRI/2025/08/093951 [Registered on: 29/08/2025] Trial Registered Prospectively |
| Last Modified On: |
28/08/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparison of carbohydrate drink and plain water before gallbladder surgery: an ultrasound study on stomach contents and safety during anaesthesia |
|
Scientific Title of Study
|
COMPARISON OF ULTRASONOGRAPHICALLY ASSESSED GASTRIC RESIDUAL VOLUME AFTER INGESTION OF A CARBOHYDRATE DRINK AND PLAIN WATER IN PATIENTS UNDERGOING LAPAROSCOPIC CHOLECYSTECTOMY: A RANDOMISED CONTROL TRIAL |
| Trial Acronym |
COUGAR-CAP |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Vishwas Pahuja |
| Designation |
Post Diploma DNB trainee |
| Affiliation |
Northern Railway Central Hospital, New Delhi |
| Address |
Ward no. 4, Department of Anaesthesiology, Northern Railway Central Hospital, basant lane, paharganj, New Delhi, Delhi 110055
Ward no. 4, Department of Anaesthesiology, Northern Railway Central Hospital, basant lane, paharganj, New Delhi, Delhi 110055
New Delhi
DELHI
110055
India |
| Phone |
8826516503 |
| Fax |
|
| Email |
vishwas.pahuja@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sushil Krishnan |
| Designation |
Assistant Chief Health Director |
| Affiliation |
Northern Railway Central Hospital, New Delhi |
| Address |
Ward no. 4, OT Complex, Department of Anaesthesiology, Northern Railway Central Hospital, Basant Lane, New Delhi
Northern Railway Central Hospital, Basant Lane, Aram Bagh, Paharganj, New Delhi, Delhi 110055
New Delhi
DELHI
110055
India |
| Phone |
9717630552 |
| Fax |
|
| Email |
dr.sushilkrishnan@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Sushil Krishnan |
| Designation |
Assistant Chief Health Director |
| Affiliation |
northern railway central hospital, new delhi |
| Address |
Ward No. 4, Department of Anaesthesiology, Northern Railway Central Hospital, basant lane, new delhi
Department of Anaesthesiology, Northern Railway Central Hospital, basant lane, new delhi
New Delhi
DELHI
110055
India |
| Phone |
9717630552 |
| Fax |
|
| Email |
dr.sushilkrishnan@gmail.com |
|
|
Source of Monetary or Material Support
|
| Northern Railway Central Hospital, New Delhi |
|
|
Primary Sponsor
|
| Name |
Northern railway central hospital |
| Address |
Northern railway central hospital, Basant lane, New Delhi 110055 |
| 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 Vishwas Pahuja |
Northern railway central hospital |
Department of anaesthesiology, northern railway central hospital, Basant lane, New Delhi 110055
New Delhi
DELHI |
8826516503
Vishwas.pahuja@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethics committee northern railway central hospital IEC-NRCH |
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 loading in pre operative period |
Ultrasound assessment of gastric volume in pre operative period in patients posted for laparoscopic cholecystectomy |
| Comparator Agent |
Plain water loading in pre operative period |
Ultrasound assessment of gastric volume in pre operative period in patients posted for laparoscopic cholecystectomy |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1. Adults (18–65 years old)
2. BMI of 18.5 to 29.9 kg per metre square
3. Scheduled for elective laparoscopic cholecystectomy under general anaesthesia
4. ASA (American Society of Anaesthesiologists) physical status I–II
• Able to provide informed consent
|
|
| ExclusionCriteria |
| Details |
• Inability of the patient to lie down in right decubitus position
• Pregnant or breastfeeding women
• History of gastrointestinal disorders (e.g., gastroparesis, gastric outlet obstruction)
• Metabolic disorders known to affect gastric emptying (diabetes mellitus, hypothyroidism, electrolyte abnormalities)
• Emergency surgeries |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
1 Antral cross sectional area CSA
2 The gastric volume (GV) will be calculated |
gastric volume assessment at 0 hours, when patient is nil per orally and 2 hours after ingestion of carbohydrate drink |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
• Aspiration after Ryle’s tube insertion at the time of surgery to assess gastric aspirate pH as pH decreases by 2.5, increases the risk of gastric aspiration
2 Incidence and severity recorded during the first 24 hours post-surgery using the simplified PONV Impact scale where the nausea ordinal response will be used to quantify nausea intensity or impact on the patient
3 All patients will complete the QoR-15 Questionnaire twice, on the morning of the surgery, in the preoperative waiting area, and 24 h following the surgery |
24 hours following the surgery |
|
|
Target Sample Size
|
Total Sample Size="72"
Sample Size from India="72"
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
|
Phase 3/ Phase 4 |
|
Date of First Enrollment (India)
|
10/09/2025 |
| 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="0"
Months="6"
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
|
Gastric volume assessment before laparoscopic surgery is a critical step to minimize the risk of aspiration and ensure patient safety during anaesthesia. Traditional methods, such as the NPO (nil per oral) guideline, are not always sufficient in assessing gastric contents, leading to a growing interest in more accurate, non-invasive techniques. One such method is the use of ultrasound to evaluate gastric volume preoperatively. The primary goal of gastric volume assessment using ultrasound is to predict the volume of gastric contents with an aim to provide a safer approach to fasting guidelines and reduce the risk of aspiration of gastric contents during general anaesthesia. Carbohydrate drinks (commonly containing glucose or maltodextrin) are rapidly absorbed and metabolized in the body, providing a quick energy source. Carbohydrate loading before surgery aims to maintain energy levels, reduce insulin resistance, and decrease the body’s reliance on fat for fuel, which can result in faster recovery after surgery. This study will be conducted as single blinded, randomised control trial to compare gastric volume in patients consuming plain water and carbohydrate drink 2 hours before the surgery after maintaining an adequate NPO of 6 hours for surgery on ultrasound along with assessment of gastric pH in patients undergoing laparoscopic cholecystectomy with assessment of QoR 15 score in post operative period. Total of 72 patients will be divided in two groups with each group having 36 patients. |