Echocardiography Based Algorithm for Prevention and Treatment of Spinal Hypotension- A Prospective Randomised Controlled Study
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Incidence of hypotension
研究概览
简要总结
The main aim of the study is to compare the proposed algorithm for preventing and treating spinal hypotension with normal anesthesia management of a spinal anesthesia.
The proposed algorithm mainly will depend upon the left ventricular end diastolic area measurement by transthoracic echocardiography to assess the left ventricular preload status and its usefulness in preventing and treating spinal hypotension.
详细描述
Aims and Objectives:
Primary aim:
To compare an echocardiography based algorithm of hemodynamic management as compared to standard practice in decreasing the incidence of spinal hypotension (number of patients developing a decrease in MAP >20% of baseline or MAP <60 mm Hg).
Secondary aims:
- To compare the number of episodes, magnitude of hypotension (lowest value of BP) and duration of hypotension in either group.
- To compare the amount of fluids and vasopressors administered to maintain hemodynamic stability in either group.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 40 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •- above 40 years of age presenting for elective lower abdominal or lower limb surgery and eligible to receive a subarachnoid block.
排除标准
- •. Patients with contraindications to a central neuraxial block such as pre- existing coagulopathy, local sepsis at site of insertion, ongoing hemodynamic instability (defined as systolic blood pressure< 90 mm Hg or MAP< 65mm Hg), unwillingness to undergo a regional anaesthesia, co- existing pregnancy, spinal dysraphism or, previous history of spinal instrumentation or surgery, chest deformity, demonstrated systolic dysfunction on screening echocardiography (defined as LVEF <50% or, fractional shortening < 25%), valvular heart disease (known or diagnosed on screening echo), chronic renal or liver disease and unwilling to participate in the trial.
研究组 & 干预措施
Gr (E)
The group in which the proposed algorithm for prevention and treatment of spinal hypotension will be tested with regard to fluid and vasopressor use, by means of echocardiography.
干预措施: Treatment of spinal hypotension (Device)
Gr (E)
The group in which the proposed algorithm for prevention and treatment of spinal hypotension will be tested with regard to fluid and vasopressor use, by means of echocardiography.
干预措施: Echocardiography (Device)
Gr (S)
The control group in which the anesthesia (fluid and vasopressor) management will be decided by the attending anesthesiologist
结局指标
主要结局
Incidence of hypotension
时间窗: 30 minutes
To compare an ECHO based algorithm of hemodynamic management as compared to standard practice in decreasing the incidence of post spinal hypotension (MAP \>20% of baseline or MAP \<60 mm Hg).
次要结局
- use of vasopressors(30 minutes)
- number of episodes of hypotension.(30 minutes)
- use of IV fluids(30 minutes)
- magnitude of hypotension.(30 minutes)
- duration of hypotension.(30 minutes)
研究者
Dr. SUNDARA KANNAN
PRINCIPAL INVESTIGATOR
Post Graduate Institute of Medical Education and Research, Chandigarh