The Phenylephrine vs. Norepinephrine Infusion Undergoing Cesarean Section

China International Neuroscience Institution

Status and phase: Completed; Phase 3; Phase 2

Conditions: Cesarean Section Complications

Treatments: Drug: Phenylephrine; Drug: Norepinephrine; Drug: Ringer's Solution

Study type: Interventional

Funder types: Other

Identifiers

NCT03833895

CINI-AD-201812-3

Details and patient eligibility

About

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

Full 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),

Enrollment: 238 patients

Sex: Female

Ages: 20 to 45 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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238 participants in 3 patient groups, including a placebo group

Group 1 Elements

Experimental group

Description:

Continuously infusion of 0.05ug/kg/min Norepinephrine during the Cesarean Section operation

Treatment:

Drug: Norepinephrine

Group 2 Elements

Experimental group

Description:

Continuously infusion of 0.25ug/kg/min phenylephrine during the Cesarean Section operation

Treatment:

Drug: Phenylephrine

Group 3 Elements

Placebo Comparator group

Description:

In the placebo-control group, 3 ml/kg/min of LR was administrated according to standard weight.

Treatment:

Drug: Ringer's Solution