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CTRI Number  CTRI/2025/01/079208 [Registered on: 22/01/2025] Trial Registered Prospectively
Last Modified On: 20/04/2026
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Surgical/Anesthesia 
Study Design  Randomized, Parallel Group, Placebo Controlled Trial 
Public Title of Study   Effect of administering Intralipid drug during the bypass in Patients Undergoing Off-Pump Coronary Artery Bypass Surgery 
Scientific Title of Study   Effect of Peri-conditioning with intralipid in Patients Undergoing Off-Pump Coronary Artery Bypass Surgery 
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 Gegal Pruthi 
Designation  Assistant Professor 
Affiliation  All India Institute of Medical Sciences, Bathinda 
Address  Department of Anaesthesia, All India Institute of Medical Sciences Bathinda, Bathinda , Punjab. Bathinda

Bathinda
PUNJAB
151001
India 
Phone  8558038098  
Fax    
Email  drpkc12@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Gegal Pruthi 
Designation  Assistant Professor 
Affiliation  All India Institute of Medical Sciences, Bathinda 
Address  Department of Anaesthesia, All India Institute of Medical Sciences Bathinda, Bathinda , Punjab. Bathinda


PUNJAB
151001
India 
Phone  8558038098  
Fax    
Email  drpkc12@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Gegal Pruthi 
Designation  Assistant Professor 
Affiliation  All India Institute of Medical Sciences, Bathinda 
Address  Department of Anaesthesia, All India Institute of Medical Sciences Bathinda, Bathinda , Punjab. Bathinda


PUNJAB
151001
India 
Phone  8558038098  
Fax    
Email  drpkc12@gmail.com  
 
Source of Monetary or Material Support  
All India Institute of Medical Sciences, Bathinda, Punjab, India - 151001 
 
Primary Sponsor  
Name  All India Institute of Medical Sciences Bathinda 
Address  All India Institute of Medical Sciences, Bathinda, Punjab, India - 151001. 
Type of Sponsor  Research institution and hospital 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Gegal Pruthi  All India Institute of Medical Sciences, Bathinda  Room number 141, Department of Anaesthesia, All India Institute of Medical Sciences, Bathinda, Punjab.
Bathinda
PUNJAB 
8558038098

drpkc12@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
AIIMS BATHINDA ethics committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: I21||Acute myocardial infarction, (2) ICD-10 Condition: I25||Chronic ischemic heart disease, (3) ICD-10 Condition: I20-I25||Ischemic heart diseases,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Intralipid Infusion  Infusion of 20% Intralipid 2ml/kg from the start of Left Internal Mammary Artery harvesting till the end of grafting over a period of 90 minutes 
Comparator Agent  Normal Saline  Normal saline 2 ml per kg from the start of Left Internal Mammary Artery harvesting till the end of grafting over a period of 90 minutes 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  70.00 Year(s)
Gender  Both 
Details  Patients posted for elective Off Pump Coronary Artery Bypass Surgery (OPCAB) with left ventricular ejection fraction (LVEF) more than 40 percentage. 
 
ExclusionCriteria 
Details  Combined valve and coronary surgery, on-pump CABG, redo cardiac surgery, hyperlipidaemia, significant hepatic or renal dysfunction, uncontrolled hypertension, diabetes mellitus, any disorder with immunological dysfunction (like malignancy or positive serological test for the HIV) in the last 6 months, preoperative treatment with nicorandil (an ATP-sensitive potassium channel opener), sulfonylurea (an ATP- sensitive potassium channel blocker). 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded 
Primary Outcome  
Outcome  TimePoints 
To evaluate the cardioprotective role of Intralipid (IL) by assessing Troponin I   postoperatively 6th hourly, 24th hourly, 48th hourly and 72nd hourly 
 
Secondary Outcome  
Outcome  TimePoints 
to find out the hemodynamic effect of intralipid on systemic circulation  intraoperatively initiating intralipid infusion at 0 min, 1 min, 5 min, 10 min, 15 min, 20min, 25 min, 30 min and postoperatively after shifting 
to estimate the clinical effect of inotropic use  intraoperatively, POD-1 and POD-2 
LVEF  at the time of discharge 
to find out the effect of intralipid on the serum levels of blood lipids, serum creatinine and total bilirubin  pre-operatively, post-operatively POD1 and POD2 
to find out the effect of intralipid on the ventilatory hours and length of ICU stay post-operatively  Post-operative period 
to find out the outcome on the complications occuring during hospitalisation including arrhythmias, stroke, infection, respiratory failure, hepatic or renal failure, reoperation and mortality will be noted  intraoperative and postoperative period 
 
Target Sample Size   Total Sample Size="62"
Sample Size from India="62" 
Final Enrollment numbers achieved (Total)= "62"
Final Enrollment numbers achieved (India)="62" 
Phase of Trial   Phase 4 
Date of First Enrollment (India)   16/02/2025 
Date of Study Completion (India) 20/03/2026 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) 20/03/2026 
Estimated Duration of Trial   Years="0"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  
Completed 
Recruitment Status of Trial (India)  Completed 
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  

Patients satisfying the inclusion criteria will be divided into 2 groups based on closed envelope technique. Patients belonging to the interventional group will be considered as Group L and thoseserving as controls will be Group C. Baseline echocardiography, liver function tests, renal function tests, serum lipid profile, cTnI , ProBNP will be noted prior to surgery. Revascularisation will be done by a single surgeon and it usually takes 60 to 90 minutes for complete revascularisation (2 to 3 grafts) in our institute. Sixty two patients, scheduled to undergo elective OPCAB surgery, will be randomly assigned to the IL group (= 31) or control (C) group (= 31); the IL group will receive an infusion of 20% IL 2 ml/kg from the start of Left Internal Mammary Artery harvesting till the end of grafting over a period of 90 minutes, whereas the control group will receive an equivalent volume of normal saline. Hemodynamics will be continuously monitored during intralipid infusion. Serum levels of cTnI and NT ProBNP will be noted before surgery and at 6 h, 24 h, 48 h, and 72 h postoperatively. Also, intraoperative hemodynamic parameters, inotrope use, ventilatory hours, ICU stay, postoperative left ventricular ejection fraction, postoperative lipid profile, renal and hepatic function tests will be measured. Echocardiography, LFTs, RFTs will be monitored prior to surgery and also on POD1 and POD3.

 
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