The Phenylephrine vs. Norepinephrine Infusion Undergoing Cesarean Section

China International Neuroscience Institution238 enrolled

Overview

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

1. 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. 2. 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),

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

TRIPLE

Enrollment

238

Conditions

Cesarean Section Complications

Interventions

NorepinephrineDRUG

0.05ug/kg/min Norepinephrine during Cesarean Section Operation

PhenylephrineDRUG

0.25ug/kg/min phenylephrine during Cesarean Section Operation

Ringer's SolutionDRUG

3 ml/kg/min of LR was administrated according to standard weight.

Eligibility

Sex: FEMALEMin age: 20 YearsMax age: 45 Years

Medical Language ↔ Plain English

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

Locations (1)

Xuanwu Hospital

Beijing, Beijing Municipality, China

Outcomes

Primary Outcomes

Systolic blood pressure (SBP) change as the one of hemodynamic outcome in general monitoring

Systolic blood pressure (SBP)

Time frame: 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)

Time frame: Through study completion

Mean arterial pressure (MAP) change as the one of hemodynamic outcome in general monitoring

Mean arterial pressure (MAP)

Time frame: An average of 24 hour

Heart rate (HR) change as the one of hemodynamic outcome in general monitoring

Heart rate (HR)

Time frame: 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)

Time frame: Through study completion, an average of 24 hour

Cardiac output (CO) as the part of LIDICO-rapid monitoring parameter for parturient

Cardiac output (CO)

Time frame: 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)

Time frame: Through study completion, an average of 24 hour

Secondary Outcomes

The benefits to the fetus based on umbilical vein (UV) blood gas

Data from ClinicalTrials.gov

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