Comparison of general versus neuraxial anaesthesia on perioperative brain natriuretic peptide levels in patients undergoing lower limb surgery - A prospective observational study.
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- Serum BNP levels were measured
研究概览
简要总结
Risk stratification of patients undergoing non-cardiac surgery is vital to minimise peri-operative adverse cardiac and cardiovascular outcomes.Surgery causes myocardial stress and increases cardiovascular risk and mortality. Cardiac biomarkers appear to be better predictors of myocardial damage across all types of surgical procedures. Amongst those predictors, troponin and brain natriuretic peptide (BNP) are the main biomarkers investigated to date.
BNP is mainly synthesised and secreted by myocytes in the left ventricle (LV) as a response to myocytes stretched by pressure overload or volume expansion of the ventricle. The synthesis and secretion of BNP can be induced by mechanical stress, systemic ischemia and hypoxia, neurohumoral factors, and more. It is used as a predictor for diagnosing and predicting the prognosis of various heart diseases. Recent studies have demonstrated that elevated serum BNP levels predict the first cardiovascular events and death in the general population. In addition, it has been reported that BNP measured before major surgery can be used as a predictor of postoperative cardiac complications.
This prospective observational case-control study aims to compare the cardiac effects of general and neuraxial anaesthesia in consideration of BNP values in lower limb surgery, the hemodynamic changes between two groups perioperatively, and the frequency of postoperative adverse events.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Participant and Outcome Assessor Blinded
入排标准
- 年龄范围
- 45.00 Year(s) 至 99.00 Year(s)（—）
- 性别
- All
入选标准
- •Patients over 45 years of age, which fulfil one or more of the following four criteria undergoing non-cardiac lower limb surgery History of coronary artery disease or/and valvular lesion with EF more than 30 percent, History of peripheral arterial disease, History of stroke OR Any three of seven- Age greater than or equal to 70 years, Undergoing major surgery, History of congestive heart failure, History of transient ischemic attack, Diabetes and currently taking an oral hypoglycaemic agent or insulin, History of Hypertension.
排除标准
- •Cardiomyopathic lesions with EF less than 30 percent.
- •Tight stenotic lesions Severe regurgitant lesions Fatal arrhythmia eg Ventricular tachycardia renal impairment Cr greater than 1.2 surgery related problems: operation longer than 3 hours patient resuscitation with more than 3 litres blood loss more than 1 liter.
结局指标
主要结局
Serum BNP levels were measured
时间窗: Preoperatively one hour before surgery and postoperatively eight hours after surgery
次要结局
- 1.Monitor changes in hemodynamics in relation to type of anesthesia.(2.Efficiency of BNP in detection for cardiac complications in the form of non-fatal MI, arrhythmias and sudden cardiac death until discharged after at least 72h.)