The Phenylephrine vs. Norepinephrine Infusion Undergoing Cesarean Section

Study Overview
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Brief Summary
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Compare 0.05 μg/kg/min Norepinephrine and 0.25 μg/kg/min phenylephrine effect on fetus and parturient during Cesarean Section

Detailed Description
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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),

Official Title
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The Phenylephrine vs. Norepinephrine Infusion by Lidico Monitoring With Pregnancy Patients Undergoing Cesarean Section

Conditions
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Cesarean Section Complications

Intervention / Treatment
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* Drug: Norepinephrine
* Drug: Phenylephrine
* Drug: Ringer's Solution


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: 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, allergy history of hypersensitivity to vasopressor body mass index (BMI) >40 kg/m2, infection at the puncture site

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Group 1 Elements<br>Continuously infusion of 0.05ug/kg/min Norepinephrine during the Cesarean Section operation | Drug: Norepinephrine<br>* 0.05ug/kg/min Norepinephrine during Cesarean Section Operation<br>* Other names: Group 1 Elements;|
| Experimental: Group 2 Elements<br>Continuously infusion of 0.25ug/kg/min phenylephrine during the Cesarean Section operation | Drug: Phenylephrine<br>* 0.25ug/kg/min phenylephrine during Cesarean Section Operation<br>* Other names: Group 2 Elements;|
| Placebo Comparator: Group 3 Elements<br>In the placebo-control group, 3 ml/kg/min of LR was administrated according to standard weight. | Drug: Ringer's Solution<br>* 3 ml/kg/min of LR was administrated according to standard weight.<br>* Other names: Group 3 Elements;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Systolic blood pressure (SBP) change as the one of hemodynamic outcome in general monitoring | Systolic blood pressure (SBP) | through study completion, an average of 24 hour | 
| Diastolic blood pressure (DBP) change as the one of hemodynamic outcome in general monitoring | Diastolic blood pressure (DBP) | Through study completion | 
| Mean arterial pressure (MAP) change as the one of hemodynamic outcome in general monitoring | Mean arterial pressure (MAP) | An average of 24 hour | 
| Heart rate (HR) change as the one of hemodynamic outcome in general monitoring | Heart rate (HR) | Through the study completion, an average of 24 hour | 
| Stroke volume (SV) as the part of LIDICO-rapid monitoring parameter for parturient | Stroke volume (SV) | Through study completion, an average of 24 hour | 
| Cardiac output (CO) as the part of LIDICO-rapid monitoring parameter for parturient | Cardiac output (CO) | Through study completion, an average of 24 hour | 
| Systemic vascular resistance (SVR) as the part of LIDICO-rapid monitoring parameter for parturient | Systemic vascular resistance (SVR) | Through study completion, an average of 24 hour | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The benefits to the fetus based on umbilical vein (UV) blood gas | The umbilical vein (UV) blood gas | Through study completion, an average of 24 hour | 
| The benefits to the fetus based on umbilical artery (UA) blood gas | The umbilical artery (UA) blood gas | Through study completion, an average of 24 hour | 
| The benefits to parturient based on peripheral vein (PV) blood gas | Peripheral vein (PV) blood gas | Through study completion, an average of 24 hour | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Cesarean delivery