Prospective Observational Study to Compare Hemodynamic Alterations in Severe Aortic Stenosis and Severe Mitral Regurgitation After High Spinal Anesthesia in Patients Undergoing Aortic Valve and Mitral Valve Replacement Surgery
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 44
- 试验地点
- 1
- 主要终点
- To compare total inotropic, inodilators and vasopressor drug requirements by calculating the vasoactive-inotropic score (VIS) Index to maintain target stable hemodynamics in both groups
研究概览
简要总结
This study will assess hemodynamic changes induced after spinal anesthesia by evaluating vasopressor inotropic requirements and variations in echocardiographic parameters in patients having severe aortic stenosis or severe mitral regurgitation undergoing aortic or mitral valve replacement surgery.
详细描述
Spinal anesthesia (SA) involves injecting local anesthetic into the intrathecal space. Since it was first described, understanding of the physiology and pharmacology of drugs acting within the subarachnoid space has improved. Physiological changes observed following SA are believed to be attributed to their blockade of peripheral and cardiac sympathetic fibers. The changes in cardiac output (CO) observed following SA were originally thought to be explained by the 'pre-load reduction' theory that describes a decrease in CO resulting from reduced venous return leading to arterial hypotension. However, this theory was questioned due to failed attempts to avoid SA induced hypotension by three preventative techniques: preloading with crystalloids or colloids, lower limb compression, and lateral tilt maneuvers (1). Additional studies and subsequent data led to further questioning of the pre-load reduction theory and supported a shift to an 'after-load reduction' theory. This proposes that hypotension following SA is a result of sympathetic blockade causing arterial dilatation (1,2). With this knowledge, it has traditionally been taught to avoid SA in severe aortic stenosis (AS) for risk of decreased coronary perfusion, while SA has been considered safe, or even beneficial in those with severe mitral regurgitation (MR). However, there is a paucity of real time evidence to help support these claims. Furthermore, individuals with experience in performing SA in patients with severe AS and/or MR have questioned the hemodynamic effects that are traditionally described (3).
With advancements in echocardiographic techniques, point of care ultrasound has emerged in critical care to become the standard for evaluating hemodynamic changes observed in hemodynamic instability or cardiovascular collapse (4). This provides an opportunity to assess CO, and its associated parameters including venous return, preload, afterload, and contractility, in real time. With this tool, one can compare the hemodynamic changes in patients with AS or MR before and after high SA given for their cardiac surgery for valve replacements or repair (AVR or MVR).
Hypothesis and Study Objectives:
This study may provide real time information to support or challenge traditional understanding of the hemodynamic changes seen following SA in those with severe AS or severe MR. Since, hemodynamic stability is goal in all patients after any type of anesthesia, the primary objective is to compare requirement of vasopressors, inotropes, and inodilators required to maintain desired hemodynamic goals (Mean arterial pressure 65-100 mmHg and HR 50-100/min) and to observe and compare hemodynamics alteration by using echocardiographic parameters of venous return, cardiac index (CI), preload, afterload, and cardiac contractility using myocardial performance index (Tei index) (5) before and after high SA in patients having predominant severe AS or MR. Furthermore, subgroup analysis will be conducted to compare hemodynamic parameters and medication requirements to meet target hemodynamic goals among patients with preserved and reduced left ventricular systolic function (for AS reduced LVEF < 50 %, for MR reduced LVEF < 60%).
Methodology:
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •All patients over 18 years of age, irrespective of their gender or ASA physical status
- •With severe aortic stenosis or mitral regurgitation
- •Undergoing elective aortic or mitral valve repair or replacement
- •Eligible for spinal anesthesia up to T1-2 level block for their surgical procedure.
- •Able to provide written informed consent
排除标准
- •Contraindications to the administration of spinal anesthesia such as pre-existing coagulopathy, local sepsis at the site of insertion
- •Hypoxic (SaO2 < 95%) on room air
- •Unable to lie flat and with 15-degree trendelenburg
- •The apical four and five chamber window is not accessible on trans-thoracic echocardiography
- •Difficult airway requiring awake intubation
- •On dialysis
- •Redo-valve surgery
- •Mixed valvular lesions (more than mild AR or MS)
- •Requiring more than one CABG or CPB duration more than 180 minutes
- •More than 3 segment Regional Wall Motion Abnormalities
- •Severe spine disorders
研究组 & 干预措施
Severe aortic stenosis group
Patients with severe aortic stenosis who are undergoing open aortic valve replacement under high spinal in combination with light general anesthesia.
干预措施: Cardiac valve replacement surgery under high spinal anesthesia combined with light general anesthesia (Procedure)
Severe mitral regurgitation group
Patients with severe mitral regurgitation who are undergoing open mitral valve replacement under high spinal in combination with light general anesthesia.
干预措施: Cardiac valve replacement surgery under high spinal anesthesia combined with light general anesthesia (Procedure)
结局指标
主要结局
To compare total inotropic, inodilators and vasopressor drug requirements by calculating the vasoactive-inotropic score (VIS) Index to maintain target stable hemodynamics in both groups
时间窗: From spinal drug injection to the starting of cardiopulmonary bypass (CPB), during CPB surgery and post CPB up to the time when patient leaves operation room
Total modified VIS score (pre CPB or on CPB or post CPB) = (total dopamine in mcg ) + (total dobutamine in mcg) + (10 x total milrinone in mcg) + (10,000 x total vasopressin unit) + (100 x total norepinephrine in mcg) + ( 100 x total epinephrine dose mcg) + (100 x total ephedrine dose in mg) VIS index = Total modified VIS score / (weight in Kg x time in minutes)
To compare changes in right and left ventricular myocardial performance index (Tei) in both groups
时间窗: Baseline pre-spinal, 2 minutes post spinal flat supine, 5 min post spinal trendelenburg 15 degree,10 minutes post general anesthesia at opening CVP pressure in trendelenburg 15 degree, 2 minute post surgical position flat supine with 5 degree back up
Tei index for the left ventricle will be derived using Doppler interrogation MV and left ventricular outflow tract (LVOT) blood flows and for both RV and LV by tissue Doppler interrogation of TV and MV lateral annular plane motion on echocardiography in both groups
To compare changes in Left Ventricular Outflow Tract (LVOT) Cardiac Index (CI) in both groups
时间窗: Baseline pre-spinal, 2 minutes post spinal flat supine, 5 min post spinal trendelenburg 15 degree,10 minutes post general anesthesia at opening CVP pressure in trendelenburg 15 degree, 2 minute post surgical position flat supine with 5 degree back up
LVOT cardiac index will be derived pulse wave Doppler interrogation of LVOT flow, 2 dimensional LVOT area and heart rate by echocardiography
次要结局
- Assessment and determination of changes in other echocardiographic parameters of LV contractility after high spinal anesthesia in severe AS and severe MR and their comparison to baseline and between these two valvular pathologies.(Baseline pre-spinal, 2 minutes post spinal flat supine, 5 min post spinal trendelenburg 15 degree,10 minutes post general anesthesia at opening CVP pressure in trendelenburg 15 degree, 2 minute post surgical position flat supine with 5 degree back up)
- Comparison of any complications in both group and subgroups during study period(From spinal drug injection to the starting of cardiopulmonary bypass (CPB), during CPB surgery and post CPB up to the time 48 hours in cardiac intensive care unit)
- Subgroup analysis of patients with preserved Left Ventricular Ejection Fraction (LVEF) and reduced LVEF for comparison of Tei index of right ventricle, and left ventricle, TAPSE, MAPSE and LVOT CI by echocardiography and VIS index to maintain target he(Similar pre-defined time points for echocardiography readings and VIS index durations as for primary end points.)
- Assessment and determination of changes in other echocardiographic hemodynamic parameters of preload, after load after high spinal anesthesia in severe AS and severe MR and their comparison to baseline and between these two valvular pathologies.(Baseline pre-spinal, 2 minutes post spinal flat supine, 5 min post spinal trendelenburg 15 degree,10 minutes post general anesthesia at opening CVP pressure in trendelenburg 15 degree, 2 minute post surgical position flat supine with 5 degree back up)
- Assessment and determination of changes in other echocardiographic parameters of RV contractility after high spinal anesthesia in severe AS and severe MR and their comparison to baseline and between these two valvular pathologies.(Baseline pre-spinal, 2 minutes post spinal flat supine, 5 min post spinal trendelenburg 15 degree,10 minutes post general anesthesia at opening CVP pressure in trendelenburg 15 degree, 2 minute post surgical position flat supine with 5 degree back up)
- Comparison of pulse oximetry and cerebral oximetry changes during study period between AS and MR patients(Baseline, at echo reading time points, and every 15 minutes afterwards to the end of surgery in both the groups)
