Comparisons of the Blood Pressure Control Ability Between Hypotension Prediction Index With Non-invasive Continuous Arterial Pressure Waveforms, Continuous Blood Pressure Monitoring With Non-invasive Continuous Arterial Pressure Waveforms, and Intermittent Blood Pressure Monitoring With Conventional Non-invasive Blood Pressureduring Neuraxial Anesthesia in Cesarean Section: a Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 255
- 试验地点
- 1
- 主要终点
- time-weighted MAP below 65 mmHg
研究概览
简要总结
The goal of this study is to compare the blood pressure control ability with HPI, ClearSight, and conventional NIBP during neuraxial anesthesia in cesarean section. The main question it aims to answer is:
Anesthesiologists can have a better control of blood pressure during cesarean section with HPI than with conventional NIBP.
During the surgery, the participants will be monitored with standard monitor and HPI with ClearSight and will be randomly assigned to three groups, including HPI group, ClearSight group, and NIBP group. Anesthesiologists will treat intraoperative hypotension with different protocols according to the participants' allocation. Investigators will compare the time-weighted average mean arterial pressure < 65mmHg with in three groups. Secondary outcomes includes the intraoperative hypotension rate, total duration of hypotension, the hypotension symptoms and signs of parturients.
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
- Single (Participant)
入排标准
- 年龄范围
- 20 Years 至 50 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •20 - 50 year-old parturients
- •scheduled cesarean delivery
- •neuraxial anesthesia
排除标准
- •parturients with preeclampsia
- •parturients with cardiovascular disease above NYHA functional class 2
- •parturients with arrhythmias, preoperative severe hypertension, or other severe cardiopulmonary diseases.
- •severe perioperative arrhythmias with or without hemodynamic instability
- •failed neuraxial anesthesia or regional blockade level below T6
结局指标
主要结局
time-weighted MAP below 65 mmHg
时间窗: through the surgery completion, an average of 1.5 hours
次要结局
- rate of hypotension related symptoms and sign of the parturients(through the surgery completion, an average of 1.5 hours)
- total vasopressor dosage(through the surgery completion, an average of 1.5 hours)
- rates of parturients with intraoperative hypotension(through the surgery completion, an average of 1.5 hours)
- total hypotension duration(through the surgery completion, an average of 1.5 hours)
- area under curve of hypotension(through the surgery completion, an average of 1.5 hours)
- average regional cerebral oxygen saturation(through the surgery completion, an average of 1.5 hours)