Coload Effect on Cardiac Output Measurement Using Transthoracic Echocardiography in Preeclamptic Patients Undergoing Cesarean Delivery
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 34
- 试验地点
- 1
- 主要终点
- Cardiac output measurement
研究概览
简要总结
There is high incidence of hypertensive disorders during pregnancy.The maternal cardiovascular system had significant changes during pregnancy. The colloid oncotic pressure is decreased during preeclampsia.
详细描述
Transthoracic echocardiography considered an accurate non-invasive device and has validity for measuring cardiac functions in pregnancy.
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, Investigator)
盲法说明
All the fluids were prepared according to the group by an anesthetist who will not be involved in data collection. All the bottles were wrapped by opaque cover.
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Pre-eclampsia
- •Age 18-45 years.
- •Singleton pregnancy scheduled for elective CS delivery under spinal anesthesia.
- •American Society of Anesthesiologists (ASA Ⅱ, Ⅲ).
排除标准
- •Body mass index < 18 or ≥40 kg/m²
- •Women presenting in labor
- •Current administration of vasoactive drugs including salbutamol and thyroxin.
- •Diabetes mellitus.
- •Hemoglobin <10 g/dl.
- •Cardiovascular, cerebrovascular, or renal disease
- •Increased serum creatinine level ≥1.1 mg/dL.
- •Contraindications to spinal anesthesia:(increased intracranial pressure, coagulopathy, or local skin infection)
研究组 & 干预措施
Crystalloid group
The patients will receive 1000 mL of ringer's acetate solution (250 mL over 5 minutes starting immediately after intrathecal injection using a pressurizer then 500 mL over 55 minutes then 250 mL over 60 minutes).
干预措施: 1000 mL of ringer's acetate solution (Drug)
Crystalloid-colloid group
Patients will receive 250 mL 6% hydroxyethyl starch 130/0.4 in 0.9% sodium chloride starting immediately after intrathecal injection then 500 mL of ringer's acetate solution then 250 mL of hydroxyethyl starch
干预措施: 250 mL 6% hydroxyethyl starch (Voluven) then 500 mL of ringer's acetate solution then 250 mL of 6% hydroxyethyl starch (Voluven) (Drug)
结局指标
主要结局
Cardiac output measurement
时间窗: 1 hour from the spinal anesthesia
1 hour post spinal anesthesia after administration of 1000 mL fluid using Transthoracic Echocardiography
次要结局
- Urine output volume(1hour and 2 hours post spinal anesthesia)
- Cardiac output measurement(5 minutes after the spinal anesthesia, after delivery of the fetus and 2 hours post spinal anesthesia)
- Left ventricular end diastolic volume (LVEDV) measurement(1 hour from the spinal anesthesia)
- Heart rate (HR)(basal (preoperative), intraoperative each 10 minutes and postoperatively every hour during first 6 hours)
- Mean Blood pressure(basal (preoperative), intraoperative each 10 minutes and postoperatively every hour during first 6 hours)
研究者
maha abou-zeid
Assistant Professor of Anesthesia and Surgical Intensive Care
Mansoura University