| CTRI Number |
CTRI/2026/04/109609 [Registered on: 28/04/2026] Trial Registered Prospectively |
| Last Modified On: |
28/04/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia
Process of Care Changes
Nutraceutical |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
In Patients with Symptomatic Cholelithiasis Undergoing Gallbladder Surgery, Does Enhanced Recovery Care Improve Recovery Compared to Standard Treatment ? |
|
Scientific Title of Study
|
ENHANCED RECOVERY AFTER
SURGERY(ERAS) PROTOCOL VERSUS
CONVENTIONAL PROTOCOL
IN PATIENTS UNDERGOING ELECTIVE
LAPAROSCOPIC CHOLECYSTECTOMY UNDER
GENERAL ANAESTHESIA: A PROSPECTIVE
RANDOMISED CONTROLLED CLINICAL TRIAL. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Varun Kumar |
| Designation |
Junior Resident Post Graduate |
| Affiliation |
Geetanjali Medical College and Hospital |
| Address |
Geetanjali Medical College and Hospital Manava Kheda NH8 Girwa Udaipur Rajasthan
Udaipur
RAJASTHAN
313001
India |
| Phone |
8586928806 |
| Fax |
|
| Email |
varukr.29@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Alka Chhabra |
| Designation |
Professor and Head Of Anaesthesiology Department |
| Affiliation |
Geetanjali Medical College and Hospital |
| Address |
Geetanjali Medical College and Hospital Manava Kheda NH8 Girwa Udaipur Rajasthan
Udaipur
RAJASTHAN
313001
India |
| Phone |
8890911487 |
| Fax |
|
| Email |
alkachhabra2008@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Anush Jain |
| Designation |
Senior Resident |
| Affiliation |
Geetanjali Medical College and Hospital |
| Address |
Geetanjali Medical College and Hospital Manava Kheda NH8 Girwa Udaipur Rajasthan
Udaipur
RAJASTHAN
313001
India |
| Phone |
9413115516 |
| Fax |
|
| Email |
anushjain06@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Geetanjali Medical College and Hospital |
| Address |
Hiranmagri Extension, Manwakhera, NH-8 Bypass, Near Eklingpura Chouraha, Udaipur, Rajasthan |
| Type of Sponsor |
Private 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 |
| Varun Kumar |
Geetanjali Medical College and Hospital, Udaipur, Rajasthan |
GEETANJALI MEDICAL COLLEGE AND HOSPITAL,Hiranmagri Extension, Manwakhera, NH-8 Bypass, Near Eklingpura Chouraha, Udaipur, Rajasthan
Udaipur
RAJASTHAN |
8586928806
varukr.29@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Human Research Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K00-K95||Diseases of the digestive system, (2) ICD-10 Condition: K801||Calculus of gallbladder with othercholecystitis, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Comparison Group |
The comparison group will remain nil per os (NPO) for both solids and liquids after 12:00 AM (midnight) on the day prior to surgery.
On the day of surgery, intravenous Ringer’s Lactate will be initiated at 7:00 AM.
Intraoperatively, the patient will receive Injection Loxicard 63.9 mg IV and Injection Nalbuphine 0.2 mg/kg IV. Fluid management will include Ringer’s Lactate at 2 mL/kg/hour calculated based on the preoperative fasting period, with 50% of the calculated deficit administered in the first hour and the remaining 50% over the subsequent 2 hours.
Postoperatively, the patient will receive Injection Paracetamol 1 g IV three times daily (TDS), alternating with Injection Tramadol 100 mg IV.
The patient will be kept nil per os for 6–8 hours postoperatively, followed by initiation of sips of water, then clear liquids, and subsequently progression to a semisolid diet. |
| Intervention |
Study Group |
The study group will receive 400 mL of Energiser syrup before 12:00 AM (midnight) on the day prior to surgery. Energiser syrup contains 50 g of carbohydrates, zinc (25%), selenium (20%), and 180 mg of sodium, with a total caloric value of 100 kcal.
On the day of surgery, 2 hours prior to the procedure, the patient will again receive 200 mL of Energiser syrup, along with Injection Ibugesic 800 mg diluted in 100 mL of 0.9% normal saline, and Tablet Paracetamol 1 g orally.
Intraoperatively, Injection Loxicard 1.5 mg/kg will be administered as a bolus, followed by a continuous infusion of Loxicard at 2 mg/kg/hour until the end of surgery.
Postoperatively, the patient will receive Injection Paracetamol 1 g IV three times daily (TDS) and Injection Ibugesic 400 mg in 100 mL normal saline TDS. Injection Tramadol 100 mg IV will be administered as a rescue analgesic if required.
Oral intake will be initiated with sips of water 2 hours after surgery, followed by clear liquids and a semisolid diet after 6 hours. Intravenous fluids will be discontinued after 2 hours.
Early mobilization will be encouraged, with active limb movements initiated after 2 hours, and the patient will be allowed to recover in a semi-recumbent position. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Age : 18--60 yrs.
Gender : both sexes.
ASA grade I and II.
Scheduled for Elective Laparoscopic Cholecystectomy |
|
| ExclusionCriteria |
| Details |
Patient refusal.
BMI more than 35 kg/m2
Pregnant and Lactating Females.
Uncontrolled DM and HTN.
Severe cardio respiratory disorder.
Severe Hepatorenal dysfunction.
History of Psychiatric illness.
Patient allergic to Non Steroidal Anti Inflammatory Drugs. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
To evaluate and compare ERAS protocol versus conventional protocol in terms of --
1. Post operative Pain ( VAS score at different time intervals ).
2. Recovery characteristics by modified aldrete scoring system more than or equal to 9.
3. Quality of recovery ( QoR-15 ).
4. Discharge readiness in terms of oral intake, time of micturition, time of flatus passed, time to ambulate. |
To evaluate and compare ERAS protocol versus conventional protocol in terms of --
1. Post operative Pain ( VAS score at different time intervals ).
2. Recovery characteristics by modified aldrete scoring system more than or equal to 9.
3. Quality of recovery ( QoR-15 ).
4. Discharge readiness in terms of oral intake, time of micturition, time of flatus passed, time to ambulate. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To evaluate barriers in implementation of ERAS protocol.
To compare the following parameters in both the groups in terms of -- Patient satisfaction score and adverse effects. |
To evaluate barriers in implementation of ERAS protocol.
To compare the following parameters in both the groups in terms of -- Patient satisfaction score and adverse effects. |
|
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Target Sample Size
|
Total Sample Size="90"
Sample Size from India="90"
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)
|
29/05/2026 |
| 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="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
|
Laparoscopic cholecystectomy is a less invasive procedure, patients can still experience complications such as postoperative nausea and vomiting (PONV), ileus, delayed mobilization, prolonged hospital stay, and unnecessary opioid-related side effects.As laparoscopic cholecystectomy remains one of the most frequently performed surgeries in our institution, advancing knowledge in this area could have a significant impact on surgical outcomes and healthcare efficiency within our hospital. Furthermore, implementing the ERAS protocol for laparoscopic cholecystectomy would represent a novel and valuable study for our institution. |