Prevention of Maternal Hypotension During Elective Caesarean Section Performed With Spinal Anaesthesia, Through Intermittent Pneumatic Compression System in the Lower Extremities.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 120
- 试验地点
- 6
- 主要终点
- The dose of needed vasopressor (phenylephrine).
研究概览
简要总结
The hypotension defined as 20 % less than the basal SBP (systolic blood pressure)and / or an absolute value <90-100 mmHg, he presents an incident of 80-85% after an anesthesia intradural in the pregnant women, fact that worries for provoking undesirable effects so much in the mother and as in the fetus /newborn baby.
The purpose of this study is to determine the effectiveness of intermittent pneumatic compression system in the lower extremities in order to reduce the vasopressors drugs requirements to maintain hemodynamic stability in pregnant women undergoing elective caesarean sections with an spinal anaesthesia.
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 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Pregnant women over 18 years scheduled for elective caesarean section in the third quarter of the pregnancy. Inform Consent signed.
排除标准
- •Caesarean section urgent / emergent
- •Caesarean section with epidural anaesthesia
- •Caesarean section of multiple pregnancies
- •Obstetric Pathology: Preeclampsia, Eclampsia, HELLP syndrome (Hemolysis Elevated Liver enzymes Low Platelet count), Small for gestational age (SGA), preterm (<32 weeks)
- •Valvular heart disease and / or ischemic
- •High blood pressure diagnosed and in treatment.
- •Morbid obesity (BMI> 40)
- •Insulin-dependent diabetes
- •Block level achieved with spinal anaesthesia> T5
- •Patients that can not meet the study protocol
结局指标
主要结局
The dose of needed vasopressor (phenylephrine).
时间窗: From the beginning of caesaria section (usually from 32 to 42 weeks of pregnancy) until the end of the surgery.
次要结局
- Effectiveness of Intermittent pneumatic compression system in order to decrease requirements of vasopressors (Phenylephrine).(From the beginning of caesaria section untill discharge of the recovery room ( a maximum of 4 hours).)
研究者
Lourdes Trillo
PhD
Parc de Salut Mar