Can Non Invasive Methods for Fluid Responsive Assessment Optimize Preventive Volemic Repletion in Order to Prevent Significant Hypotension After Spinal Anesthesia? A Randomized Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 429
- 试验地点
- 2
- 主要终点
- Percentage of Participants With Systemic Hypotensions
研究概览
简要总结
Spinal anesthesia is still the regional anesthesia technique most widely employed in everyday clinical practice.
The most feared and common of its well known side effects consist in an abrupt reduction of systemic vascular resistances, with consequence risk of systemic hypotension. To prevent this potentially severe complication, an adequate correction of patients' volume status through a preventive administration of fluids is widely used.
However this volume repletion is commonly accomplished on an empirical basis, without having a real insight of patient hemodynamic status, carrying the risk of possible volume overload.
Aim of the study is to test the clinical impact of two simple, non-invasive methods to guide volemic repletion before spinal anesthesia on the reduction of significant hypotension rate, compared to empirical fluid administration.
详细描述
The resulting high density of the anesthetic block and the reproducibility of the technique have made of spinal anesthesia the most widely diffused regional anesthesia technique. Nevertheless the procedure still remains the regional anesthesia technique burdened by the potentially most severe side effects, the most frequent of which being systemic arterial hypotension.
Subarachnoidal administration of local anesthetics in fact is associated not only with both a motor and sensory block, but also with a blockade of the autonomic nervous system, which controls peripheral vascular tone. Sympathetic block leads to a sudden decrease in peripheral resistance, with consequent significant increase in vascular bed and relative hypovolemia.
Transient hypotensive episodes can be generally well tolerated by healthy patients, however they may lead to major complications in patients with increased cardiovascular risk. In the common clinical practice, it is usual to administer fluids empirically. An empirical preventive fluid repletion however can represent per se a risk in patients with impaired cardiac and renal functions, since a volume overload of heart chambers with reduced compliance can cause pulmonary edema or congestive heart failure.
Since about ten years both non-invasive and invasive techniques have been developed, with the specific purpose of optimizing fluid status on a rational basis. This methods are based on the correlation between the levels of mean arterial pressure (MAP), systemic vascular resistance (SVR) and cardiac output (CO), according to the equation: MAP = CO * SVR. The latter explains why, in case of vasodilation, unless CO is increased, a lowering of SVR will inevitably translate into a decrease of MAP.
Determinants of blood pressure are:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •all adult non critical patients requiring elective spinal anesthesia
- •patients with American Society of Anesthesiology class level I, II and III according to international standards
- •spontaneously breathing patients
排除标准
- •patients already equipped or requiring invasive blood pressure monitoring (arterial catheter, pulmonary catheter, thermodilution catheter)
- •patients with pre-procedural hypotension, defined as a response in two consecutive measurements of systolic arterial pressure (SAP) less than 80 mmHg or mean arterial pressure (MAP) less of 60 mmHg.
- •patients unable to give informed consent to communication difficulties to language barriers or processes congenital/acquired determinants of mental retard, or any reduction in their ability to understand or want to be able to give their informed consent to the study
- •patients where it is not then possible to perform spinal anesthesia for the patient's refusal to technical difficulties in sampling, clinical pathological conditions for determining a high risk of peri- procedural complications.
- •patients with International Normalized Ratio > 1.5 and/or activated partial thromboplastin time in therapeutic range (defined as a value more than 1.5-2 times the normal values of the patient), anti-Xa activity in the therapeutic range .
- •patients with severe thrombocytopenia (<50 G/l)
结局指标
主要结局
Percentage of Participants With Systemic Hypotensions
时间窗: 30 minutes
Primary objective is to quantify significant hypotension rate after spinal anesthesia in patients brought to euvolemia according to the Trans-Thoracic Echocardiography and PLRT (Passive Leg Raising Test), compared to patients treated with the current standard. For arterial hypotension, in accordance with the international standard definitions, now define a drop in systolic blood pressure over 50 mmHg from baseline, an absolute value of systolic blood pressure less than 80 mm Hg, a mean arterial pressure below 60 mmHg or hypotension clinically symptomatic (dizziness, pallor, sweating, nausea).
次要结局
- Pre-anesthesia Fluid Amount(Time between operating room entry and spinal anesthesia, up to 30 min.)
- Post-anesthesia Fluid Amount(30 minutes)
研究者
Samuele Ceruti
Capoclinica Medicina Intensiva
Ente Ospedaliero Cantonale, Bellinzona