FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2021/06/034090 [Registered on: 08/06/2021] Trial Registered Prospectively
Last Modified On: 13/05/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Surgical/Anesthesia 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   Studying the effects of two different hypnotic agents (Propofol & Etomidate) on relaxation function of left heart 
Scientific Title of Study   Effect of Intravenous Propofol Versus Etomidate on Components of Left Ventricular Diastolic Function A Double Blinded, Randomized, Controlled Trial 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Shanmugappriya 
Designation  Junior Resident in Anaesthesiology  
Affiliation  Jawaharlal Institute of Postgraduate Medical Education and Research 
Address  Department of Anaesthesiology and Critical Care, Jawaharlal Institute of Postgraduate Medical Education and Research, Dhanvantri nagar, Puducherry
Department of Anaesthesiology and Critical Care, Jawaharlal Institute of Postgraduate Medical Education and Research, Dhanvantri nagar, Puducherry
Pondicherry
PONDICHERRY
605006
India 
Phone  8124656802  
Fax    
Email  shanmugappriya29@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Senthilnathan Muthapillai 
Designation  Assistant Professor 
Affiliation  Jawaharlal Institute of Postgraduate Medical Education and Research 
Address  Department of Anaesthesiology and Critical Care, Jawaharlal Institute of Postgraduate Medical Education and Research, Dhanvantri nagar, Puducherry

Pondicherry
PONDICHERRY
605006
India 
Phone  7598566983  
Fax    
Email  mmc.senthil@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Senthilnathan Muthapillai 
Designation  Assistant Professor 
Affiliation  Jawaharlal Institute of Postgraduate Medical Education and Research 
Address  Department of Anaesthesiology and Critical Care, Jawaharlal Institute of Postgraduate Medical Education and Research, Dhanvantri nagar, Puducherry

Pondicherry
PONDICHERRY
605006
India 
Phone  7598566983  
Fax    
Email  mmc.senthil@gmail.com  
 
Source of Monetary or Material Support  
Jawaharlal Institute of Postgraduate Medical Education and Research, Dhanvantri nagar, Puducherry-605006, India 
 
Primary Sponsor  
Name  Jawaharlal Institute of Postgraduate Medical Education and Research 
Address  Jawaharlal Institute of Postgraduate Medical Education and Research, Dhanvantri nagar, Puducherry 
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 Shanmugappriya  Jawaharlal Institute of Postgraduate Medical Education and Research  Department of Anaesthesiology and Critical Care, Second floor, Institute block, Jawaharlal Institute of Postgraduate Medical Education and Research, Dhanvantri nagar, Puducherry
Pondicherry
PONDICHERRY 
8124656802

shanmugappriya29@gmail.com 
 
Details of Ethics Committee
Modification(s)  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
JIPMER Institutional 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,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Pharmacological Intervention  Studying the effect of Etomidate on diastolic function of left heart in patients undergoing surgery under general anaesthesia; 0.3 mg per kg of Etomidate will be administered via Intravenous route over the span of 30 seconds 
Intervention  Pharmacological Intervention  Studying the effect of Propofol on diastolic function of left heart in patients undergoing surgery under general anaesthesia; 2 mg per kg of propofol will be administered via Intravenous route over the span of 30 seconds 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  70.00 Year(s)
Gender  Both 
Details  Adult patients (>18 years of age) with ASA PS 1 or 2 requiring surgery under general anaesthesia will be recruited in this study 
 
ExclusionCriteria 
Details  Patients with pre-existing cardiac lesions will be excluded from this study. 
 
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 
Comparison of the changes in E/e prime between the groups  After administration of the study drug, E/e prime will be measured and its change with baseline (before administration of the study drug) will be studied. 
 
Secondary Outcome  
Outcome  TimePoints 
1) Comparison of change in e prime velocities between the groups
2) Comparison of change in E/A between the groups
3) Comparison of change in TRmax jet velocity between the groups
4) Comparison of change in LA volume indices be-tween the groups
5) Comparison of change in deceleration time between the groups 
After the administration of the study drug, changes in the aforementioned parameters from the baseline will be studied  
 
Target Sample Size   Total Sample Size="168"
Sample Size from India="168" 
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)   01/07/2021 
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="2"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   NIL 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary
Modification(s)  

After obtaining approval from Post-graduate Research Monitoring Committee and Institute Ethics Committee, this study will be registered in Clinical Trial Registry-India. Adult patients (>18 years) with ASA PS 1 or 2, undergoing surgery under general anaesthesia will be included in this study after obtaining informed written consent. Patients will be premedicated with tablet diazepam 0.1 mg.kg-1 on the night prior to surgery and on the morning of surgery. Patients will be kept fasting as per American Society of Anaesthesiologists (ASA) guidelines. Baseline vital parameters will be obtained after connecting the patients with ECG, non-invasive blood pressure (NIBP) and pulse oximetry. Low frequency echocardiography probe (1-5 mHz, My LabX5, Esaote, Genova, Italy) will be used to record the study parameters. LV diastolic function will be assessed by an anaesthesiologist who has experience in transthoracic echocardiography (TTE) at least for one year. Apical-four chamber (A4C) view will be obtained by placing the echocardiographic probe over the apical impulse and by keeping the probe horizontally with orientation marker facing left side. Pulse wave Doppler sampling will be obtained at mitral valvular leaflet tips to obtain E wave which represents early passive diastolic filling and A wave that results from atrial contraction. Deceleration time will be obtained from E wave. E/A ratio will be calculated. Tissue Doppler Imaging will be utilized to measure mitral annular peak velocities. Tissue Doppler sampling will be done at septal mitral annulus to obtain septal eËŠ; it will be done in lateral mitral annulus to obtain lateral eËŠ. The machine will calculate average E/eËŠ. Left atrial (LA) maximal volume index will be obtained by measuring its length and transverse diameter in A4C or apical 2 chamber view, one to two frames prior to opening of the mitral valve. Tricuspid regurgitation maximum velocity will be obtained by placing the continuous wave Doppler at the regurgitant jet area (can be located by colour flow Doppler) in A4C view. After obtaining these baseline echocardiographic variables, patient will be induced. All patients will receive Ringer’s lactate at rate of 10 ml.kg-1.hour-1 after securing intravenous line. Patients in group P will be induced with 2 mg.kg-1 of propofol and patients in group E will be induced with 0.3 mg.kg-1 of etomidate. Induction agent will be administered over the span of 30 seconds. Ventilation of the patient will be assisted with breathing circuit of anaesthesia workstation (with FiO2 of 1.0), if required. Depth of anaesthesia will be monitored by BIS (Bispectral Index) every minute till the end of this study. Heart rate, NIBP and SpO2 will be monitored for every minute till the end of this study. The aforementioned parameters will be measured in sequence, 30 seconds after administration of the induction drugs. After completion of this study, patients will be managed as per the discretion of the attending anaesthesiologist.

 
Close