Clinical trial NCT03833895: The Phenylephrine vs. Norepinephrine Infusion Undergoing Cesarean Section
Official title: The Phenylephrine vs. Norepinephrine Infusion by Lidico Monitoring With Pregnancy Patients Undergoing Cesarean Section
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Cesarean Section Complications
Keywords: Cesarean delivery
Lead sponsor: China International Neuroscience Institution
Sponsor class: OTHER
First posted: 2019-02-07
Enrollment: 238
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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),

Eligibility criteria: 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

Primary outcomes:
measure: Systolic blood pressure (SBP) change as the one of hemodynamic outcome in general monitoring
timeFrame: through study completion, an average of 24 hour
measure: Diastolic blood pressure (DBP) change as the one of hemodynamic outcome in general monitoring
timeFrame: Through study completion
measure: Mean arterial pressure (MAP) change as the one of hemodynamic outcome in general monitoring
timeFrame: An average of 24 hour
measure: Heart rate (HR) change as the one of hemodynamic outcome in general monitoring
timeFrame: Through the study completion, an average of 24 hour
measure: Stroke volume (SV) as the part of LIDICO-rapid monitoring parameter for parturient
timeFrame: Through study completion, an average of 24 hour
measure: Cardiac output (CO) as the part of LIDICO-rapid monitoring parameter for parturient
timeFrame: Through study completion, an average of 24 hour
measure: Systemic vascular resistance (SVR) as the part of LIDICO-rapid monitoring parameter for parturient
timeFrame: Through study completion, an average of 24 hour
Secondary outcomes:
measure: The benefits to the fetus based on umbilical vein (UV) blood gas
timeFrame: Through study completion, an average of 24 hour
measure: The benefits to the fetus based on umbilical artery (UA) blood gas
timeFrame: Through study completion, an average of 24 hour
measure: The benefits to parturient based on peripheral vein (PV) blood gas
timeFrame: Through study completion, an average of 24 hour
Other outcomes:
Locations:
city: Beijing
country: China
facility: Xuanwu Hospital
state: Beijing
Study officials:
affiliation: Xuanwu Hospital, Beijing
name: Tianlong Wang, MD,PHD
role: STUDY_CHAIR
References:
citation: Feng K, Wang X, Feng X, Zhang J, Xiao W, Wang F, Zhou Q, Wang T. Effects of continuous infusion of phenylephrine vs. norepinephrine on parturients and fetuses under LiDCOrapid monitoring: a randomized, double-blind, placebo-controlled study. BMC Anesthesiol. 2020 Sep 7;20(1):229. doi: 10.1186/s12871-020-01145-0.