| CTRI Number |
CTRI/2024/12/078252 [Registered on: 17/12/2024] Trial Registered Prospectively |
| Last Modified On: |
16/12/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Prospective Randomised study |
| Study Design |
Other |
|
Public Title of Study
|
Effect of Sevoflurane with Propofol on left ventricular diastolic function in patients undergoing coronary artery bypass graft |
|
Scientific Title of Study
|
Effect of sevoflurane with propofol on left ventricular diastolic function in patients undergoing coronary artery bypass graft using cardiopulmonary bypass a prospective randomised observational Study |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Muthu M |
| Designation |
postgraduate resident |
| Affiliation |
armed forces medical college |
| Address |
armed forces medical college pune 411040 Department of anaesthesia and critical care pune 411040 Pune MAHARASHTRA 411040 India |
| Phone |
9655154931 |
| Fax |
|
| Email |
muthum1321989@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Alok kumar |
| Designation |
Professor |
| Affiliation |
Armed forces medical college |
| Address |
Armed forces medical college pune 411040 Department of anaesthesia and critical care pune 411040 Pune MAHARASHTRA 411040 India |
| Phone |
8146044104 |
| Fax |
|
| Email |
mipayal07@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Dr Nihar Ameta |
| Designation |
Assistant professor |
| Affiliation |
Armed forces medical college |
| Address |
Armed forces medical college pune 411040 Department of anaesthesia and critical care pune 411040 Pune MAHARASHTRA 411040 India |
| Phone |
8551055667 |
| Fax |
|
| Email |
nihar.ameta@gmail.com |
|
|
Source of Monetary or Material Support
|
| Armed Forces Medical College
Pune,Maharashtra-411040 |
|
|
Primary Sponsor
|
| Name |
Muthu M |
| Address |
Depatment of anaesthesia and critical care, Armed forces medical college, pune-411040 |
| Type of Sponsor |
Other [Self] |
|
|
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 Muthu |
AICTS |
AICTS
Pune
MAHARASHTRA-411040 Pune MAHARASHTRA |
9655154931
muthum1321989@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| BORS |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
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Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: I229||Subsequent ST elevation (STEMI) myocardial infarction of unspecified site, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Inhalational agent Sevoflurane |
Effect of inhalational agent sevoflurane on left ventricular diastolic function in patients undergoing CABG using cardiopulmonary bypass |
| Comparator Agent |
Intravenous propofol |
Effect of intravenous propofol on left ventricular diastolic function in patients undergoing CABG on cardiopulmonary bypass |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
90.00 Year(s) |
| Gender |
Both |
| Details |
Adult patients undergoing elective coronary artery bypass graft surgery using cardiopulmonary bypass.
|
|
| ExclusionCriteria |
| Details |
Decreased Left ventricular ejection fraction ,Cardiomyopathy,Pre existing valvular heart disease,Pre existing diastolic dysfunction, Atrial fibrillation, Significant pulmonary diseases, Emergency procedure, Oesophageal pathology
|
|
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Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To evaluate left ventricular diastolic function by measuring Peak flow velocity of early diastolic filling/ Early diastolic mitral annulus velocity using Transesophageal echocardiography under sevoflurane or propofol based anaesthesia in patients undergoing Coronary artery bypass graft on cardiopulmonary bypass |
After intubation and after weaning from cardiopulmonary bypass |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To compare other parameters of diastolic and systolic function between sevoflurane and propofol group that is Late diastolic filling, Deceleration time, Peak systolic flow velocity, Peak diastolic flow velocity, S/D ratio, Peak reversal atrial flow, Duration of reverse atrial flow, Left Ventricular Ejection Fraction.
To determine the Vasoactive inotropic Score between sevoflurane group and propofol group.
To assess the duration of Mechanical ventilation and ICU stay between sevoflurane group and propofol group
|
after intubation and after weaning from cardiopulmonary bypass |
|
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Target Sample Size
|
Total Sample Size="100" Sample Size from India="100"
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)
|
30/12/2024 |
| 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="1" Months="6" Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
This study will be a Comparative observational study assessing the effect of sevoflurane with propofol on left ventricular diastolic function undergoing on-pump CABG surgery. Patients meeting the inclusion criteria will be randomly assigned to one of the two groups: the Sevoflurane group or propofol Group . Randomization will be achieved using lottery method for first case followed by alternating the methods in successive individuals. The study will be conducted in the Tertiary care hospital. Institute ethical committee clearance certification will be sought and obtained before the study begin. Informed written consent will be obtained from all the study participants before including them in the study after explaining them implications of the study. This study will be conducted on patients planned to undergo coronary artery bypass graft surgery with normal diastolic function. Standard fasting guidelines will be followed. Upon arrival in the operating room, standard monitoring (five-lead ECG, SpO2 and non-invasive blood pressure) will be commenced. We will insert a 20-G arterial cannula under local anaesthesia in the radial artery, and a triple lumen central venous pressure (CVP) catheter in the right internal jugular vein using full aseptic technique. Group A -sevoflurane group: Anaesthesia will be induced using propofol 1-1.5mg/kg and fentanyl 3–5mcg/kg,titrate according to haemodynamics. Will perform Intubation with cisatracurium 0.1 mg/kg. Anaesthesia maintenance will be done using sevoflurane 1 MAC in 50% oxygen and air, and cisatracurium 2 mcg/kg/min.
Group B -Propofol group: Anaesthesia will be induced using propofol 1-1.5mg/kg and fentanyl 3–5mcg/kg,titrate according to haemodynamics. Will perform Intubation with cisatracurium 0.1 mg/kg. Anaesthesia maintenance with a continuous infusion of propofol 1.5-4.5 mg/kg/h, and cisatracurium 2 mcg/kg/min. A bispectral index electrode (BIS-Sensor) will be positioned on the patient’s forehead to monitor depth of anaesthesia, and the BIS value maintenance between 45 and 55 in both groups by adjusting the propofol infusion rate or inhaled sevoflurane concentration. We continuously monitor heart rate (HR), systolic, diastolic and mean arterial pressures (SBP, DBP and MAP) along with CVP. We will perform a complete transesophgeal echocardiography (TEE) examination using a commercially available multiplane TEE probe according to the American society of Echocardiography/society of Cardiovascular Anaesthesiologist guidelines. Transoesophageal echocardiography evaluation data will be recorded in three stages, as follows: 1.Transmitral diastolic Doppler flow profile: Obtaining the mid oesophageal four chamber view and pulsed wave Doppler examination done by placing the Doppler sample volume at the tips of the mitral valve leaflets in the LV during diastole. The peak flow velocity of early diastolic filling (E), peak flow velocity of late diastolic filling associated with atrial contraction (A), E/A ratio, A wave duration and deceleration time (DT) for early diastolic filling will be recorded. 2. Tissue Doppler imaging by placing the sample at the lateral mitral valve ring in the mid esophageal four chamber view. A typical TDI signal consist of three waves; early (e)’ late (a’) diastolic , and a systolic (Sm) waves. 3. Pulmonary venous flow velocity using pulsed wave Doppler by placing the sample volume in the left upper pulmonary vein, 0.5-1 cm distal to its junction with the left atrium. Values for the peak systolic flow velocity (S), peak diastolic flow velocity (D), S/D ratio, peak reversal atrial flow (Ar) and duration of reverse atrial flow (Ar dur). All echocardiography data for statistical analysis will be recorded by TEE immediately after tracheal intubation as a baseline(T0); and 15 min after weaning from bypass (T1).whereas hemodynamic data (HR,MAP and CVP) VIS Score will be recorded at T0,T1. Transthoracic echocardiography will be done in ICU post operative on Day 0 and Day 1 for assessment of diastolic function.
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