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CTRI Number  CTRI/2022/02/039898 [Registered on: 01/02/2022] Trial Registered Prospectively
Last Modified On: 30/12/2023
Post Graduate Thesis  No 
Type of Trial  Observational 
Type of Study   Comparative study 
Study Design  Non-randomized, Active Controlled Trial 
Public Title of Study   A clinical trial to compare the effect of two sleep causing drugs namely etomidate and propofol-phenylephrine combination on heart rate and blood pressure in adult patients undergoing open heart surgeries 
Scientific Title of Study   Hemodynamic profiles of etomidate vs propofol-phenylephrine combination for induction of anaesthesia in adult cardiac surgical patients 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Molli Kiran 
Designation  Assistant Professor 
Affiliation  All India Institute of Medical Sciences, Bhopal 
Address  AIIMS, Saket nagar, Bhopal
AIIMS, Saket nagar, Bhopal
Bhopal
MADHYA PRADESH
462020
India 
Phone  9441497323  
Fax    
Email  mvr934@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Molli Kiran 
Designation  Assistant Professor 
Affiliation  All India Institute of Medical Sciences, Bhopal 
Address  AIIMS, Saket nagar, Bhopal
AIIMS, Saket nagar, Bhopal
Bhopal
MADHYA PRADESH
462020
India 
Phone  9441497323  
Fax    
Email  mvr934@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Molli Kiran 
Designation  Assistant Professor 
Affiliation  All India Institute of Medical Sciences, Bhopal 
Address  AIIMS, Saket nagar, Bhopal
AIIMS, Saket nagar, Bhopal
Bhopal
MADHYA PRADESH
462043
India 
Phone  9441497323  
Fax    
Email  mvr934@gmail.com  
 
Source of Monetary or Material Support  
None 
 
Primary Sponsor  
Name  Molli Kiran 
Address  Arvind Vihar 
Type of Sponsor  Other [Self] 
 
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 
Molli Kiran  All India Institute of Medical Sciences, Bhopal  Department of Anaesthesiology, Modular Operation theatre complex, Third floor
Bhopal
MADHYA PRADESH 
9441497323

mvr934@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Human Ethics Committee  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, (2) ICD-10 Condition: I052||Rheumatic mitral stenosis with insufficiency,  
 
Intervention / Comparator Agent  
Type  Name  Details 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  70.00 Year(s)
Gender  Both 
Details  Adult ASA II-IV patients undergoing elective cardiac surgeries involving valve replacement and/or coronary artery bypass grafting surgeries who are willing to participate in the study. 
 
ExclusionCriteria 
Details  1. Patients with known allergy to the study drugs
2. Emergency surgeries
3. Patients with anticipated difficult airway and patients who require more than 2 attempts or more than 30 seconds for direct laryngoscopy
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
1. Heart rate, systolic blood pressure, diastolic blood pressure and mean arterial pressure every 30 sec for the first ten minutes after induction  first ten minutes after anaesthesia induction 
 
Secondary Outcome  
Outcome  TimePoints 
number of extra doses of phenyl ephrine needed in both the groups  first ten minutes of induction 
 
Target Sample Size   Total Sample Size="64"
Sample Size from India="64" 
Final Enrollment numbers achieved (Total)= "90"
Final Enrollment numbers achieved (India)="90" 
Phase of Trial   N/A 
Date of First Enrollment (India)   07/02/2022 
Date of Study Completion (India) Date Missing 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) 18/12/2023 
Estimated Duration of Trial   Years="0"
Months="9"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  
Closed to Recruitment of Participants 
Recruitment Status of Trial (India)  Completed 
Publication Details   nil 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary  

Propofol and etomidate are the two commonly used induction agents in anaesthesia practice. In patients who are critically ill and in patients with cardiovascular disease, etomidate is preferred as it causes less hypotension compared to propofol. But retrospective studies have proposed an association between the use of etomidate for anaesthesia induction and increased risk of mortality, morbidity in septic or critically ill patients.(1) In spite of these concerns, etomidate is favored for induction of anaesthesia in cardiac surgery patients, in whom hemodynamic stability immediately after induction of anaesthesia is paramount.

     The important factors producing cardiovascular depression due to propofol are direct myocardial depression and decreased systemic vascular resistance (SVR). Phenylephrine is a pure alpha agonist which increases venous return and SVR which can counter propofol induced vasodilation. In non-cardiac surgery, studies have shown that phenylephrine mixed with propofol when administered for induction of anaesthesia reduces the hypotension due to propofol. (2,3,4)

   Our primary hypothesis is that if propofol-phenylephrine combination has non-inferior hemodynamic profiles to that of etomidate, the former can replace the latter.  
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