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The Phenylephrine vs. Norepinephrine Infusion Undergoing Cesarean Section

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

Status
Completed
Phases
Phase 2Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03833895
Enrollment
238
Registered
2019-02-07
Start date
2019-02-20
Completion date
2019-09-02
Last updated
2020-02-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cesarean Section Complications

Keywords

Cesarean delivery

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),

Interventions

DRUGNorepinephrine

0.05ug/kg/min Norepinephrine during Cesarean Section Operation

DRUGPhenylephrine

0.25ug/kg/min phenylephrine during Cesarean Section Operation

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

Sponsors

China International Neuroscience Institution
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
TRIPLE (Subject, Caregiver, Outcomes Assessor)

Eligibility

Sex/Gender
FEMALE
Age
20 Years to 45 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Systemic vascular resistance (SVR) as the part of LIDICO-rapid monitoring parameter for parturientThrough study completion, an average of 24 hourSystemic vascular resistance (SVR)
Heart rate (HR) change as the one of hemodynamic outcome in general monitoringThrough the study completion, an average of 24 hourHeart rate (HR)
Stroke volume (SV) as the part of LIDICO-rapid monitoring parameter for parturientThrough study completion, an average of 24 hourStroke volume (SV)
Cardiac output (CO) as the part of LIDICO-rapid monitoring parameter for parturientThrough study completion, an average of 24 hourCardiac output (CO)
Systolic blood pressure (SBP) change as the one of hemodynamic outcome in general monitoringthrough study completion, an average of 24 hourSystolic blood pressure (SBP)
Diastolic blood pressure (DBP) change as the one of hemodynamic outcome in general monitoringThrough study completionDiastolic blood pressure (DBP)
Mean arterial pressure (MAP) change as the one of hemodynamic outcome in general monitoringAn average of 24 hourMean arterial pressure (MAP)

Secondary

MeasureTime frameDescription
The benefits to the fetus based on umbilical artery (UA) blood gasThrough study completion, an average of 24 hourThe umbilical artery (UA) blood gas
The benefits to parturient based on peripheral vein (PV) blood gasThrough study completion, an average of 24 hourPeripheral vein (PV) blood gas
The benefits to the fetus based on umbilical vein (UV) blood gasThrough study completion, an average of 24 hourThe umbilical vein (UV) blood gas

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 17, 2026