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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  
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 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  
Status 
Not Applicable 
 
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
 
 
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 
 
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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