The Phenylephrine vs. Norepinephrine Infusion Undergoing Cesarean Section

Cesarean Section Complications Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03833895
• Other study ID #: CINI-AD-201812-3
• Status: Completed
• Phase: Phase 2/Phase 3
• Start date: February 20, 2019
• Est. completion date: September 2, 2019

Study information

• Verified date: February 2020
• Source: China International Neuroscience Institution
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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 information / eligibility

• Status: Completed
• Enrollment: 238
• Est. completion date: September 2, 2019
• Est. primary completion date: September 1, 2019
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 20 Years to 45 Years

Eligibility

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

Related Conditions & MeSH terms

• Cesarean Section Complications

Intervention

Drug:
• Norepinephrine
0.05ug/kg/min Norepinephrine during Cesarean Section Operation
• Phenylephrine
0.25ug/kg/min phenylephrine during Cesarean Section Operation
• Ringer's Solution
3 ml/kg/min of LR was administrated according to standard weight.

Locations

Country	Name	City	State
China	Xuanwu Hospital	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
China International Neuroscience Institution

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Diastolic blood pressure (DBP) change as the one of hemodynamic outcome in general monitoring	Diastolic blood pressure (DBP)	Through study completion
Primary	Mean arterial pressure (MAP) change as the one of hemodynamic outcome in general monitoring	Mean arterial pressure (MAP)	An average of 24 hour
Primary	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
Primary	Stroke volume (SV) as the part of LIDICO-rapid monitoring parameter for parturient	Stroke volume (SV)	Through study completion, an average of 24 hour
Primary	Cardiac output (CO) as the part of LIDICO-rapid monitoring parameter for parturient	Cardiac output (CO)	Through study completion, an average of 24 hour
Primary	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	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
Secondary	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
Secondary	The benefits to parturient based on peripheral vein (PV) blood gas	Peripheral vein (PV) blood gas	Through study completion, an average of 24 hour