| CTRI Number |
CTRI/2023/02/049598 [Registered on: 09/02/2023] Trial Registered Prospectively |
| Last Modified On: |
07/02/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Effects of two commonly used anaesthetic agents on mitral valve dynamics for left ventricular function assessment using transesophageal echocardiography. |
|
Scientific Title of Study
|
Effects of sevoflurane versus propofol on mitral annular displacement evaluated
using speckle tracking. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Suda Naveen Kumar |
| Designation |
Senior resident |
| Affiliation |
Sree Chitra Tirunal Institute of Medical Sciences and Technology. |
| Address |
Division of Cardiac Anaesthesiology,
Sree Chitra Tirunal Institute of Medical Sciences and Technology.
Thiruvananthapuram
KERALA
695011
India |
| Phone |
|
| Fax |
|
| Email |
sudanaveen@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Shrinivas V Gadhinglajkar |
| Designation |
Senior Professor |
| Affiliation |
Sree Chitra Tirunal Institute for Medical Sciences and Technology. |
| Address |
Head of the department,
Division of Cardiac Anaesthesia,
Sree chitra tirunal institute for medical sciences and Technology SCTIMST.
Thiruvananthapuram
KERALA
695011
India |
| Phone |
|
| Fax |
|
| Email |
shri@sctimst.ac.in |
|
Details of Contact Person
Public Query
|
| Name |
Suda Naveen Kumar |
| Designation |
Senior resident |
| Affiliation |
Sree Chitra Tirunal Institute of Medical Sciences and Technology. |
| Address |
Division of Cardiac Anaesthesiology,
Sree Chitra Tirunal Institute for Medical Sciences and Technology.
Thiruvananthapuram
KERALA
695011
India |
| Phone |
|
| Fax |
|
| Email |
sudanaveen@gmail.com |
|
|
Source of Monetary or Material Support
|
| Division of Cardiac Anaesthesiology,
Sree Chitra Tirunal Institute for Medical Sciences and Technology. |
|
|
Primary Sponsor
|
| Name |
SCTIMST |
| Address |
SCTIMST, Trivandrum |
| 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 |
| S Naveen Kumar |
Sree chitra tirunal institute for medical sciences and technology |
Division of Cardiac Anaesthesia,
SCTIMST,Thiruvananthapuram.
Thiruvananthapuram
KERALA |
9885520970
sudanaveen@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| institutional ethics committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: I21A||Other type of myocardial infarction, (2) ICD-10 Condition: I252||Old myocardial infarction, , (3) ICD-10 Condition: O||Medical and Surgical, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
propofol |
In propofol group, 50 t0 100mcg/kg/ min infusion of propofol given throughout the surgery to maintain depth of anesthesia. |
| Comparator Agent |
Sevoflurane |
Sevoflurane 1% to 2% to maintain minimum alveolar concentration 0.7 to 1, throughout the cardiac surgery to maintain depth of anesthesia |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
75.00 Year(s) |
| Gender |
Both |
| Details |
All Adult patients scheduled for elective CABG under CPB.
Age group between 18 – 75 years.
Normal sinus rhythm.
|
|
| ExclusionCriteria |
| Details |
Patients with other associated complex anomalies.
Patients with more than mild MS, MR, AS or AR.
Patients with severe mitral annular calcification.
Contraindication to TEE probe placement.
Patient refusing to participate in the project.
Poor 2D & 3D image quality
Emergency and Redo surgeries.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
To study intraoperative differences in MAPSE, mitral annular velocity with TDI and TMAD in CABG patients.
To compare effects of sevoflurane and propofol anaesthesia on changes in MAPSE, mitral annular velocity with TDI and TMAD on CABG patients.
To compare differences between GLS and MAPSE, mitral annular velocity with TDI and TMAD in CABG patients.
|
intraoperative |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To ascertain intraobserver and interobserver variability between TMAD and MAPSE and GLS
|
intraoperative |
|
|
Target Sample Size
|
Total Sample Size="88"
Sample Size from India="88"
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)
|
10/02/2023 |
| 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="0"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
study not yet started |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Left ventricular (LV) systolic function is a predictor for perioperative morbidity and mortality in patients undergoing coronary artery bypass grafting (CABG) . Patients having coronary artery disease with preserved left ventricular ejection fraction may have subclinical myocardial dysfunction possibly due to subendocardial ischemia, which is characterised by impaired global longitudinal strain. Transesophageal echocardiography (TEE) is a corner-stone for assessing LV systolic function in routine intraoperative practice. Two dimensional speckle-tracking strain (2D-STI) using echocardiographic imaging allows the angle-independent evaluation of myocardial strain in the three directions (radial, circumferential, and longitudinal), providing comprehensive information on LV myocardial contractility and may be better than other 2D based calculations of LV systolic function like ejection fraction.Tissue motion annular displacement of the mitral valve (TMAD) is a new parameter of evaluation of longitudinal systolic function of the left ventricle. |