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
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- 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
研究概览
简要总结
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.
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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.
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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.
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 18.00 Year(s) 至 90.00 Year(s)(—)
- 性别
- All
入选标准
- •Adult patients undergoing elective coronary artery bypass graft surgery using cardiopulmonary bypass.
排除标准
- •Decreased Left ventricular ejection fraction ,Cardiomyopathy,Pre existing valvular heart disease,Pre existing diastolic dysfunction, Atrial fibrillation, Significant pulmonary diseases, Emergency procedure, Oesophageal pathology.
结局指标
主要结局
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
时间窗: After intubation and after weaning from cardiopulmonary bypass
次要结局
- 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.)
研究者
Dr Muthu M
armed forces medical college
