Evaluation of the Efficiency of Leg Elevation for Preventing Post Spinal Hypotension in Cesarean Section
试验速览
- 阶段
- 不适用
- 入组人数
- 200
- 试验地点
- 2
- 主要终点
- Incidence of post spinal hypotension
研究概览
简要总结
Prospective trial including full term parturients scheduled for a cesarean section under spinal anesthesia. patients are being randomly assigned into 2 groups:
LE group: will be positioned in 15° left tilt with leg elevation with a 30cm height pillow under the heels, this position will be hold after spinal anesthesia until fetal extraction.
Control group: will be positioned in supine with 15° left tilt. the 2 groups will receive a 10ml/kg of crystalloid co-load intravenously, and the spinal anesthesia will be performed in sitting position with the same dose of Bupivacain, morphine and sufentanil.
详细描述
Prospective trial including full term parturients scheduled for a cesarean section under spinal anesthesia. patients are being randomly assigned into 2 groups:
LE group: will be positioned in 15° left tilt with leg elevation with a 30cm height pillow under the heels, this position will be hold after spinal anesthesia until fetal extraction.
Control group: will be positioned in supine with 15° left tilt. the 2 groups will receive a 10ml/kg of crystalloid co-load intravenously, and the spinal anesthesia will be performed in sitting position with the same dose of Bupivacain, morphine and sufentanil. we will record the demographic data, pre and intraoperative hemodynamic parameters, the dose of ephedrine required to treat post spinal hypotension and fetal parameters: pH and blood lactates
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Sequential
- 主要目的
- Prevention
- 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
- •full term parturients
- •age> 18 Y
- •scheduled of elective or urgent cesarean section under spinal anesthesia
排除标准
- •patients who had general anesthesia
研究组 & 干预措施
LE: leg elevation group
the patients of this group will be positionned in supine with 15° left tilt and will have a leg elevation with a 30 cm pillow positionned under the heels. this position will be hold immediately after spinal anesthesia until fetal extraction
干预措施: leg elevation (Other)
CG: Control group
The patients of this group will be positiooned in supine with 15° left tlit after spinal anesthesia. no leg elevation
结局指标
主要结局
Incidence of post spinal hypotension
时间窗: during the first 30minutes after the spinal anesthesia
change of systolic blood pressure from baseline\< 90 mmHg
次要结局
- Lowest systolic blood pressure(during the first 30 minutes following spinal anesthesia)
- ephedrine consumption(during the first 30 minutes following the spinal anesthesia)
- Fetal ph(30 minutes after spinal anesthesia)
- Fetal blood lactates(30 minutes after spinal anesthesia)
研究者
Mhamed Sami Mebazaa
Professor head of the anesthesia and intensive care department
Mongi Slim Hospital