Comparison of the Effects of Crystal Solution (Lactic Acid Ringer's Solution) and Colloid Solution (Hydroxyethyl Starch) on Mother and Fetus After Cesarean Section
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- hypotension
研究概览
简要总结
Comparison of the effects of crystal solution (lactic acid Ringer's solution) and colloid solution (hydroxyethyl starch) on mother and fetus after cesarean section
详细描述
The Hydroxyethl group use 10 ml/kg hydroxyethl starch as well as goal-directed fluid therapy with 3ml/kg hydroxyethl starch. The control group 10 ml/kg Lactated Ringer's solution as well as goal-directed fluid therapy with 3ml/kg Lactated Ringer's solution. During the whole operation of elective cesarean section
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 20 Years 至 40 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Healthy singleton pregnancy scheduled for elective cesarean section under CSEA; American Society of Anesthesiologists (ASA) physical status Ⅰ/Ⅱ; Age ranging from 20 to 40 years old.
排除标准
- •History of mental disorder or epilepsy; History of central nervous system (CNS) disease; Preexisting or pregnancy-induced hypertension; History of lumber injury; Severe hypovolemia; Allergy or hypersensitivity to norepinephrine; Body mass index (BMI) above 40 kg/m2; Infection at the puncture site; Tricyclic or imipramine antidepressants.
研究组 & 干预措施
hydroxyethl starch group
10 ml/kg hydroxyethl starch as well as goal-directed fluid therapy with 3ml/kg hydroxyethl starch
干预措施: hydroxyethl starch (Drug)
The control group
10 ml/kg Lactated Ringer's solution as well as goal-directed fluid therapy with 3ml/kg Lactated Ringer's solution
干预措施: Lactated Ringer's solution (Drug)
结局指标
主要结局
hypotension
时间窗: during operation procedure
The incidence of maternal hypotension during the operation
次要结局
- umbilical vein blood gases(24 hours)
- umbilical artery blood gases(24 hours)
- Hemodynamic data at time point(24 hours)
- Maternal vein blood gase(24 hours)
- The incidences of maternal complications(24 hours)