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CTRI Number  CTRI/2024/10/075524 [Registered on: 18/10/2024] Trial Registered Prospectively
Last Modified On: 27/12/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Surgical/Anesthesia 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   Comparison of tissue perfusion using difference in partial pressure of venous and arterial Carbon dioxide during Sevoflurane Inhalation (anaesthetic agent) versus Propofol (anaesthetic agent) Infusion for maintenance of Anaesthesia in elective Off-Pump Coronary Artery Bypass Grafting surgery 
Scientific Title of Study   Comparison of tissue perfusion using difference in partial pressure of venous and arterial Carbon dioxide difference during Sevoflurane inhalation versus propofol Infusion for maintenance of Anaesthesia In elective off-pump Coronary Artery Bypass Grafting 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  Manasmita Dalai 
Designation  Senior Resident 
Affiliation  PGIMS Rohtak 
Address  Department of Cardiac Anaesthesia, PGIMS Rohtak

Rohtak
HARYANA
124001
India 
Phone  09438811991  
Fax    
Email  manasmita.bini@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Indira Malik 
Designation  Associate Professor  
Affiliation  PT . B. D. Sharma PGIMS, Rohtak  
Address  Department of Cardiac Anaesthesia, PGIMS Rohtak

Rohtak
HARYANA
124001
India 
Phone  9350224435  
Fax    
Email  mdr.indira@yahoo.in  
 
Details of Contact Person
Public Query  
Name  Indira Malik 
Designation  Associate Professor  
Affiliation  PT . B. D. Sharma PGIMS, Rohtak  
Address  Department of Cardiac Anaesthesia, PGIMS Rohtak

Rohtak
HARYANA
124001
India 
Phone  9350224435  
Fax    
Email  mdr.indira@yahoo.in  
 
Source of Monetary or Material Support  
PT B. D. Sharma, PGIMS Rohtak, Pin code- 124001, District-Rohtak, State- Haryana, country- India 
 
Primary Sponsor  
Name  Pandit Bhagwat Dayal Sharma Post Graduate Institute of Medical Sciences Rohtak 
Address  Department of Cardiac Anaesthesia, Pandit Bhagwat Dayal Sharma Post Graduate Institute of Medical Sciences, Rohtak 
Type of Sponsor  Government medical college 
 
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 Manasmita Dalai  Pandit Bhagwat Dayal Sharma Post Graduate Institute of Medical Sciences, Rohtak  Department of Cardiac Anaesthesia, near Cardiothoracic Vascular Surgery OT complex, first floor, Lala Shyamlal building
Rohtak
HARYANA 		 9438811991

manasmita.bini@gmail.com 
 
Details of Ethics Committee
Modification(s)  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Biomedical Research Ethics Committee, Pt B. D. Sharma, PGIMS, UHS, Rohtak   Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: O||Medical and Surgical,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Propofol infusion   Injection propofol will be given at a dose of 50-150 mcg/ kg/min in the form of infusion during elective off-pump coronary artery bypass grafting surgery for maintenance of anaesthesia. 
Comparator Agent  Sevoflurane Inhalation  Sevoflurane Inhalation anaesthesia at MAC 1 with mixture of Oxygen and air in 1:1 will be given for maintenance of anaesthesia during elective off- pump coronary artery bypass grafting surgery. 
 
Inclusion Criteria  
Age From  40.00 Year(s)
Age To  80.00 Year(s)
Gender  Both 
Details  Adult patients (40 to 80 years of age), Both sex,
American Society of Anesthesiology (ASA- II, III,
Elective OPCABG surgery.  
 
ExclusionCriteria 
Details  Patients with left ventricular ejection fraction less than 30%, Patients with history of severe hepatic, renal dysfunction, Chronic obstructive pulmonary disease (COPD) with FEV1 less than 50%, PaCO2 more than 60mmHg, Patients undergoing combined surgical procedures (CABG combined with valve surgery
aortic procedure, and carotid surgery), Redo surgeries, Patients with sepsis and septic shock, Emergency CABG,
Off- pump CABG converted to on pump,
Patients with serum lactate more than 3.0 mmol/L preoperatively, Patients with associated valvular heart disease, Symptomatic peripheral artery disease, Pregnant patients, Patient refusal  
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant and Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
1.To compare tissue perfusion between the two groups by calculation of the difference in the partial pressure of carbon dioxide in arterial, central, and mixed venous samples,
2.To correlate the above with serum lactate levels.  		 T0 (post induction).T1(2 hours post induction), T2 (4 hours post induction) and thereafter in post-operative ICU at T3 (3 hours post operatively), T4 (6 hours post operatively), T5 (18 hours postoperatively), T6 (24 hours postoperatively), T7 (48 hours postoperatively 
 
Secondary Outcome  
Outcome  TimePoints 
1. To measure cardiac output and pulmonary artery catheter (PAC) derived parameters via thermodilution technique using cold saline injectate 2. To compare changes in haemodynamic variables (heart rate, systolic blood pressure, diastolic blood pressure, mean arterial pressure, central venous pressure) during intraoperative period in both the groups 3. To calculate the Vasoactive-Inotropic Score (VIS) 4. To compare the length of ICU stay 5. Complications / adverse events (if any)   T0 (post induction).T1(2 hours post induction), T2 (4 hours post induction) and thereafter in post-operative ICU at T3 (3 hours post operatively), T4 (6 hours post operatively), T5 (18 hours postoperatively), T6 (24 hours postoperatively), T7 (48 hours postoperatively) 
 
Target Sample Size   Total Sample Size="60"
Sample Size from India="60" 
Final Enrollment numbers achieved (Total)= "54"
Final Enrollment numbers achieved (India)="54" 
Phase of Trial   Phase 4 
Date of First Enrollment (India)   01/11/2024 
Date of Study Completion (India) 31/12/2025 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="1"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
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 - YES
  1. What data in particular will be shared?
    Response - All of the individual participant data collected during the trial, after de-identification.

  2. What additional supporting information will be shared?
    Response -  Study Protocol
    Response -  Statistical Analysis Plan

  3. Who will be able to view these files?
    Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.

  4. For what types of analyses will this data be available?
    Response - For individual participant data meta-analysis.

  5. By what mechanism will data be made available?
    Response - To gain access, data requestors will need to sign a data access agreement. Data are available for 5 years at a third party website (NIL).

  6. For how long will this data be available start date provided 01-03-2027 and end date provided 29-02-2032?
    Response - Beginning 3 months and ending 5 years following article publication.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NIL
Brief Summary   Tissue perfusion will be compared using difference in partial pressure of carbon dioxide in venous and arterial blood between patients maintained on sevoflurane inhalation and those who will be maintained on propofol infusion during off-pump coronary artery bypass grafting surgery. This value will be correlated with serum lactate levels obtained from arterial blood gas analysis. This study will be conducted in PT B. D. Sharma, PGIMS Rohtak. Study duration will be one year 
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