| CTRI Number |
CTRI/2018/07/014997 [Registered on: 20/07/2018] Trial Registered Prospectively |
| Last Modified On: |
23/04/2022 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Multiple Arm Trial |
|
Public Title of Study
|
Effect of Different Anaesthesia Drugs on Function of Heart |
|
Scientific Title of Study
|
Echocardiographic comparison of left ventricular function using different Anaesthesia Induction techniques |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Indranil Biswas |
| Designation |
Senior Resident |
| Affiliation |
Post Graduate Institute of Medical Education and Research, Chandigarh |
| Address |
Department of Anaesthesia and Intensive Care, Post Graduate Institute of Medical Education and Research, Chandigarh
Chandigarh
CHANDIGARH
160012
India |
| Phone |
|
| Fax |
|
| Email |
hreesheekombartta@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Prof Goverdhan Dutt Puri |
| Designation |
Professor and Head of Department |
| Affiliation |
Post Graduate Institute of Medical Education and Research, Chandigarh |
| Address |
Department of Anaesthesia and Intensive Care, Post Graduate Institute of Medical Education and Research, Chandigarh
Chandigarh
CHANDIGARH
160012
India |
| Phone |
|
| Fax |
|
| Email |
gdpuri007@hotmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Prof Goverdhan Dutt Puri |
| Designation |
Professor and Head of Department |
| Affiliation |
Post Graduate Institute of Medical Education and Research, Chandigarh |
| Address |
Department of Anaesthesia and Intensive Care, Post Graduate Institute of Medical Education and Research, Chandigarh
Chandigarh
CHANDIGARH
160012
India |
| Phone |
|
| Fax |
|
| Email |
gdpuri007@hotmail.com |
|
|
Source of Monetary or Material Support
|
| Post Graduate Institute of Medical Education and Research Chandigarh |
|
|
Primary Sponsor
|
| Name |
Post Graduate Institute of Medical Education and Research Chandigarh |
| Address |
Post Graduate Institute of Medical Education and Research, Chandigarh, Chandigarh. Pin- 160012 |
| Type of Sponsor |
Government medical college |
|
|
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 Indranil Biswas |
Advanced Cardiac Centre, Post Graduate Institute of Medical Education and Research, Chandigarh |
CTVS OT, 4th floor, Advanced Cardiac Centre
Chandigarh
CHANDIGARH |
7710449858
hreesheekombartta@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, Postgraduate Institute of Medical Education and Research, Chandigarh |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
Modification(s)
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: I251||Atherosclerotic heart disease of native coronary artery, (2) ICD-10 Condition: I060||Rheumatic aortic stenosis, (3) ICD-10 Condition: I350||Nonrheumatic aortic (valve) stenosis, (4) ICD-10 Condition: I712||Thoracic aortic aneurysm, withoutrupture, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Etomidate |
Bispectral Index (BIS) feedback-guided closed loop administration of Etomidate via infusion to achieve and maintain a target BIS of 50 |
| Intervention |
Induction of General Anaesthesia by different anaesthetic agents |
Evaluate and compare the changes in echocardiographic parameters of Left Ventricular function upon induction of General Anaesthesia by three different anaesthetic agents |
| Comparator Agent |
Propofol |
Bispectral Index (BIS) feedback-guided closed loop administration of Propofol via infusion to achieve and maintain a target BIS of 50 |
| Comparator Agent |
Sevoflurane |
Anaesthesia will be induced using the vital capacity rapid inhalational induction (VCRII) technique with 5% sevoflurane in 100% oxygen (6 L/min) via a closed anaesthesia circuit |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Patients of either sex of the age group 18-65 years, undergoing Coronary Artery Bypass Grafting/ Valve replacement or repair surgery/ Combined Coronary Artery Bypass Grafting and Valve surgery/ Combined Valve and ascending aortic procedure/ surgery for correction or palliation of congenital heart diseases |
|
| ExclusionCriteria |
| Details |
1.Allergy to any of the drugs to be administered
2. Significant Mitral Annular Calcification
3. Regional dysfunction in the basal myocardial segments
4. Surgical rings or prosthetic mitral valves
5. Severe LV dysfunction (LVEF < 35%)
6. Pericardial disease
7. Poor echo window
8. Atrial fibrillation/Significant rhythm disturbance
9. H/o steroid use within last 6 months
10. H/o adrenal insufficiency
11. Significant Renal/Hepatic/CNS dysfunction
12. BMI> 35 kg/m2
|
|
|
Method of Generating Random Sequence
|
Permuted block randomization, fixed |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To evaluate and compare the effects of anaesthetic induction by Propofol, Etomidate and Sevoflurane on the echocardiographic parameters of Left Ventricular Function (Peak Global Longitudinal Strain, Septal and Lateral Mitral Annular S’) in adult patients undergoing cardiac surgeries. |
1. Baseline
2. Post Induction (Upon reaching target BIS of 50)
3. Post Intubation (Within 1 minute after endotracheal intubation) |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To evaluate and compare the effects of anaesthetic induction by Propofol, Etomidate and Sevoflurane on the echocardiographic parameters of cardiac preload (LVEDVI), cardiac afterload (Ea), Left ventricular function (LV ejection fraction, Septal and Lateral Mitral Annular ’, E’, A’ velocities, Tei Index, P/V Ratio), Mitral inflow velocities (E velocity, A velocity, E wave deceleration time). |
1. Baseline
2. Post Induction (Upon reaching target BIS of 50)
3. Post Intubation (Within 1 minute after endotracheal intubation) |
| To observe any side effects of the anaesthetic agents used |
Throughout during the Induction and Intubation period |
| To find out correlation between the change in preload and afterload parameters (EDVI, Ea, SVRI) respectively and the change in the systolic function parameters (Peak Global Longitudinal Strain, EF, Tei Index, Septal and Lateral Mitral Annular S’ velocities, P/V ratio) from baseline to that after induction |
From baseline to after induction |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
Final Enrollment numbers achieved (Total)= "61"
Final Enrollment numbers achieved (India)="61" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
01/08/2018 |
| Date of Study Completion (India) |
31/12/2019 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
31/12/2019 |
|
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
|
None yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
A randomised, prospective, parallel group, multiple arm trial to evaluate and compare the changes in echocardiographic parameters of Left Ventricular Function upon induction of General anaesthesia by three different anaesthetic agents- Propofol, Etomidate and Sevoflurane. This trial has been planned as a thesis/dissertation, required for the degree of DM (Cardiac Anaesthesia) of Post Graduate Institute of Medical Education and Research, Chandigarh. |