Hypotension Prediction Index Therapy is Non-inferior to Continuous Norepinephrine Infusion for Fetal Wellbeing in the Prevention of Spinal Anesthesia-Induced Hypotension for Cesarean Delivery: a Randomized Controlled Trial
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 入组人数
- 150
- 主要终点
- Fetal Base excess
研究概览
简要总结
The goal of this randomized controlled trial is to compare for non inferiority for fetal wellbeing Hypotension Prediction Index - Guided Therapy and Continuous Norepinephrine Infusion in in the Prevention of Spinal Anesthesia-Induced Hypotension for Cesarean Delivery.
The main question it aims to answer are:
• are fetal arterial base excess comparable with the two treatments?
Participants will undergo continuous noninvasive hemodynamic monitoring with advanced Hypotension Prediction Index Researchers will compare with patients receiving continuous norepinephrine infusion and standard blood pressure monitoring with arm cuff.
详细描述
In the Hypotension Prediction Index group, patients will be monitored continuously with a noninvasive hemodynamic device. The Hypotension Prediction Index is a number based on al algorithm that predicts impeding hypotension if it is greater than 85. In the treatment group, patients will be treated with norepinephrine boluses if the Hypotension Prediction Index is >85. In the control group patients will be treated with preventive continuous infusion of norepinephrine and blood pressure will be measured noninvasively every minute. Data about blood pressure and the vasopressive treatment will start concomitantly to the administration of spinal anesthesia and will stop after delivery. blood gas samples will be then collected from the placental umbilical artery to compare fetal arterial base excess as primary outcome for non-inferiority.
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
- None
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Pregnant women between the 36th and the 40th week of gestation undergoing spinal anesthesia for elective caesarian delivery.
排除标准
- •preeclampsia;
- •eclampsia;
- •atrial fibrillation and sinus tachycardia;
- •cardiovascular diseases;
- •neuromuscular disease;
- •emergent or urgent cesarean delivery;
- •coagulopathies;
- •contraindications to spinal anesthesia.
研究组 & 干预措施
Hypotension Prediction Index
Patients will be monitored with Hypotension Prediction Index which will guide vasopressor therapy with boluses of norepinephrine
干预措施: Hypotension Prediction Index (Device)
Hypotension Prediction Index
Patients will be monitored with Hypotension Prediction Index which will guide vasopressor therapy with boluses of norepinephrine
干预措施: Norepinephrine (Drug)
Non Invasive Blood Pressure
Spinal-induced hypotension will be prevented by continuous preventive norepinephrine infusion and blood pressure will be monitored by non invasive arm cuff every minute
干预措施: Norepinephrine (Drug)
结局指标
主要结局
Fetal Base excess
时间窗: at birth
withdrawn from umbilical fetal artery as index of perioperative metabolic acidosis
次要结局
- Hypertensive episodes(from spinal anesthesia until delivery)
- Apgar score(at 5 minutes from birth)
- Hypotensive episodes(from spinal anesthesia until delivery)
- Total vasopressor dose(from spinal anesthesia until delivery)
- Fetal arterial pH(at birth)