The Phenylephrine vs. Norepinephrine Infusion Undergoing Cesarean Section
- Conditions
- Cesarean Section Complications
- Interventions
- Registration Number
- NCT03833895
- Lead Sponsor
- China International Neuroscience Institution
- Brief Summary
Compare 0.05 μg/kg/min Norepinephrine and 0.25 μg/kg/min phenylephrine effect on fetus and parturient during Cesarean Section
- Detailed Description
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),
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 238
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Group 3 Elements Ringer's Solution In the placebo-control group, 3 ml/kg/min of LR was administrated according to standard weight. Group 1 Elements Norepinephrine Continuously infusion of 0.05ug/kg/min Norepinephrine during the Cesarean Section operation Group 2 Elements Phenylephrine Continuously infusion of 0.25ug/kg/min phenylephrine during the Cesarean Section operation
- Primary Outcome Measures
Name Time Method Diastolic blood pressure (DBP) change as the one of hemodynamic outcome in general monitoring Through study completion Diastolic blood pressure (DBP)
Stroke volume (SV) as the part of LIDICO-rapid monitoring parameter for parturient 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 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 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 An average of 24 hour Mean arterial pressure (MAP)
Heart rate (HR) change as the one of hemodynamic outcome in general monitoring 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 Through study completion, an average of 24 hour Systemic vascular resistance (SVR)
- Secondary Outcome Measures
Name Time Method The benefits to the fetus based on umbilical vein (UV) blood gas Through study completion, an average of 24 hour The umbilical vein (UV) blood gas
The benefits to parturient based on peripheral vein (PV) blood gas Through study completion, an average of 24 hour Peripheral vein (PV) blood gas
The benefits to the fetus based on umbilical artery (UA) blood gas Through study completion, an average of 24 hour The umbilical artery (UA) blood gas
Trial Locations
- Locations (1)
Xuanwu Hospital
🇨🇳Beijing, Beijing, China