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
|
|
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
|
|
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 eˊ; it will be done in lateral mitral annulus to obtain lateral eˊ. The machine will calculate average E/eˊ. 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. |