The Phenylephrine vs. Norepinephrine Infusion by Lidico Monitoring With Pregnancy Patients Undergoing Cesarean Section
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 238
- 试验地点
- 1
- 主要终点
- Diastolic blood pressure (DBP) change as the one of hemodynamic outcome in general monitoring
研究概览
简要总结
Compare 0.05 μg/kg/min Norepinephrine and 0.25 μg/kg/min phenylephrine effect on fetus and parturient during Cesarean Section
详细描述
- Compare 0.05 μg/kg/min Norepinephrine and 0.25 μg/kg/min phenylephrine and control group effect on parturient hemodynamic change (systolic blood pressure SBP, diastolic blood pressure DBP,mean arterial pressure MAP,heart rate HR) and on LIDICO-rapid monitoring ( stroke volume SV, systemic vascular resistance SVR, cardiac output CO) and peripheral vein (PV) blood gas during Cesarean Section.
- Compare 0.05 μg/kg/min Norepinephrine and 0.25 μg/kg/min phenylephrine and control group effect on fetus by blood gas of the umbilical vein (UV), umbilical artery (UA),
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, Care Provider, Outcomes Assessor)
入排标准
- 年龄范围
- 20 Years 至 45 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •a healthy singleton pregnancy scheduled for elective cesarean delivery (CD) under combined spinal-epidural anesthesia (CSEA),
- •American Society of Anesthesiologists (ASA) physical status I/II
- •20 to 40 years old
排除标准
- •history of mental disorder or epilepsy,
- •tricyclic or imipramine antidepressant use,
- •central nervous system (CNS) disease,
- •preexisting or pregnancy-induced hypertension,
- •lumbar injury,
- •severe hypovolemia,
- •history of hypersensitivity to vasopressor
- •body mass index (BMI) >40 kg/m2,
- •infection at the puncture site
研究组 & 干预措施
Group 1 Elements
Continuously infusion of 0.05ug/kg/min Norepinephrine during the Cesarean Section operation
干预措施: Norepinephrine (Drug)
Group 2 Elements
Continuously infusion of 0.25ug/kg/min phenylephrine during the Cesarean Section operation
干预措施: Phenylephrine (Drug)
Group 3 Elements
In the placebo-control group, 3 ml/kg/min of LR was administrated according to standard weight.
干预措施: Ringer's Solution (Drug)
结局指标
主要结局
Diastolic blood pressure (DBP) change as the one of hemodynamic outcome in general monitoring
时间窗: Through study completion
Diastolic blood pressure (DBP)
Stroke volume (SV) as the part of LIDICO-rapid monitoring parameter for parturient
时间窗: Through study completion, an average of 24 hour
Stroke volume (SV)
Systolic blood pressure (SBP) change as the one of hemodynamic outcome in general monitoring
时间窗: through study completion, an average of 24 hour
Systolic blood pressure (SBP)
Cardiac output (CO) as the part of LIDICO-rapid monitoring parameter for parturient
时间窗: Through study completion, an average of 24 hour
Cardiac output (CO)
Mean arterial pressure (MAP) change as the one of hemodynamic outcome in general monitoring
时间窗: An average of 24 hour
Mean arterial pressure (MAP)
Heart rate (HR) change as the one of hemodynamic outcome in general monitoring
时间窗: Through the study completion, an average of 24 hour
Heart rate (HR)
Systemic vascular resistance (SVR) as the part of LIDICO-rapid monitoring parameter for parturient
时间窗: Through study completion, an average of 24 hour
Systemic vascular resistance (SVR)
次要结局
- The benefits to the fetus based on umbilical vein (UV) blood gas(Through study completion, an average of 24 hour)
- The benefits to parturient based on peripheral vein (PV) blood gas(Through study completion, an average of 24 hour)
- The benefits to the fetus based on umbilical artery (UA) blood gas(Through study completion, an average of 24 hour)