Cardiac Output Changes in Cesarean Section
Primary Purpose
Cardiac Output,Low, Hemodynamic Instability, Obstetrical Complication of Anesthesia
Status
Unknown status
Phase
Early Phase 1
Locations
Study Type
Interventional
Intervention
Norepinephrine
Phenylephrine
Sponsored by
About this trial
This is an interventional treatment trial for Cardiac Output,Low focused on measuring cardiac output, norepinephrin, cesarean section
Eligibility Criteria
Inclusion Criteria:
- age >=18 years,<=40 years;
- height 150-180 cm;
- weight 55-80 kg;
- full-term gestation (>36 wk and <41 wk)
- singleton pregnancy undergoing elective cesarean section under CSEA
Exclusion Criteria:
- contraindications to spinal anesthesia;
- patients with any complicated pregnancy;
- fetal compromise;
- need of emergency;
- in labor
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
phenylephrine
norepinephrine
Arm Description
phenylejphrine (one bolus for 40 ug/ml)
norepinephrine (one bolus for 2 ug/ml)
Outcomes
Primary Outcome Measures
cardiac output
Secondary Outcome Measures
systolic blood pressure
heart rate
Apgar score
Umbilical cord arterial blood pH/BE/Lac
umbilical plasma catecholamine concentration
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02759510
Brief Title
Cardiac Output Changes in Cesarean Section
Official Title
Comparison of Norepinephrine and Phenylephrine in Cesarean Section by Transesophageal Ultrasound
Study Type
Interventional
2. Study Status
Record Verification Date
April 2016
Overall Recruitment Status
Unknown status
Study Start Date
June 2016 (undefined)
Primary Completion Date
June 2016 (Anticipated)
Study Completion Date
June 2017 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
RenJi Hospital
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
Since 2011, phenylephrine was recommended as the preferred drug to maintain blood pressure in obstetric anesthesia.Phenylephrine, an α adrenoceptor agonist, can induce peripheral vasoconstriction to maintain blood pressure, while reflexly decrease heart rate and result in cardiac output (CO) reduction.Norepinephrine acts not only as an α adrenoceptor receptor agonist, but also as a weaker β adrenergic receptor agonist. It can elevate blood pressure the same asphenylephrine, meanwhile produce positive inotropic effect including increasing heart rate.Thus, the administration of norepinephrine can maintain blood pressue and avoid the decline of CO. The purpose of this study is to evaluate the effect of norepinephrine and phenylephrine on maternal CO in cesarean section by transesophageal echocardiography.
Detailed Description
Combined spinal epidural anesthesia (CSEA) is a commonly used anesthetic methods in cesarean section. The main problem of CSEA is hypotension, which will cause maternal nausea and vomiting, reduced uteroplacental blood flow and fetal acidosis. One of the important methods for prevention and treatment of hypotension after CSEA is to give vasoactive drugs.
Since 2011, phenylephrine was recommended as the preferred drug to maintain blood pressure in obstetric anesthesia.Phenylephrine, an α adrenoceptor agonist, can induce peripheral vasoconstriction to maintain blood pressure, while reflexly decrease heart rate and result in cardiac output (CO) reduction.Dyer et al. used bioimpedance technique to analyze the hemodynamic changes in normal pregnant women. A bolus of 80 ug phenylephrine was administrated when maternal mean arterial pressure decreased 20% after CSEA. It was found that cardiac output (CO) decreased significantly (14%) after phenylephrine administrationcompared with the baseline.And the decrease of CO induced by phenylephrine was in a dose dependent.All the studies referred above recruitednormal pregnant women, and the decreased CO did not have an adverse effect on neonatal birth. However, as we all know, the decrease of CO will influence uteroplacental blood, which may lead to adverse results in existed intrauterine distress fetal. All authors of those studies stressed that the decrease of CO induced by phenylephrine may increase the risks of fetal distress or other adverse consequences. So, it is crucial for obstetric anesthesiologist to choose a suitable vasoactive drugs, which can maintain both maternal blood pressure and uteroplacental perfusion in order to keep intrauterine environment steady.
Norepinephrine acts not only as an α adrenoceptor receptor agonist, but also as a weaker β adrenergic receptor agonist. It can elevate blood pressure the same asphenylephrine, meanwhile produce positive inotropic effect including increasing heart rate.Thus, the administration of norepinephrine can maintain blood pressue and avoid the decline of CO. And norepinephrine is superior to phenylephrine in the respect of organ perfusion.
There is little research about the administration of norepinephrine in obstetric anesthesia.Ngan Kee et al.compared phenylephrine (0.57μg/kg/min) with norepinephrine (0.035μg/kg/min) in the treatment of hypotension in obstetric anesthesia. CO monitored by a suprasternal Doppler ultrasound every 5 minutes. CO and heart rate was significantly higher in norepinephrine group than that in phenylephrine group, while peripheral vascular resistance was significantly lower in norepinephrine group than that in phenylephrine group. And the oxygen content in umbilical venous was significantly higher in norepinephrine group, which may be related to the norepinephrine induced lower peripheral vascular resistance and high cardiac output.Monitoring of CO can give a comprehensive understanding of hemodynamics in the pregnant. It enables obstetric anesthesiologist to use liquid expansion rationally and administrate vasoactive agents properly.Although the accuracy of suprasternal Doppler ultrasound was high in that study, the interval of 5min to monitor CO may miss the rapid changes in hemodynamics of pregnant women.In the present study, we will monitor CO continuously by a small diameter (6 mm) transesophageal echocardiography, which can be retained in the patient's esophagus.
The purpose of this study is to evaluate the effect of norepinephrine and phenylephrine on maternal CO in cesarean section by transesophageal echocardiography.Fetal umbilical cord blood, neonatal 1min Apgar score, 5 min Apgar scores and neonatal plasma catecholamine concentrations will be collected to understand the effects of norepinephrine and phenylephrine on fetal.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cardiac Output,Low, Hemodynamic Instability, Obstetrical Complication of Anesthesia
Keywords
cardiac output, norepinephrin, cesarean section
7. Study Design
Primary Purpose
Treatment
Study Phase
Early Phase 1
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
106 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
phenylephrine
Arm Type
Active Comparator
Arm Description
phenylejphrine (one bolus for 40 ug/ml)
Arm Title
norepinephrine
Arm Type
Experimental
Arm Description
norepinephrine (one bolus for 2 ug/ml)
Intervention Type
Drug
Intervention Name(s)
Norepinephrine
Intervention Description
Hypotension (systolic BP <80% of baseline) will be treated with intravenous boluses of norepinephrine 2 μg.
Intervention Type
Drug
Intervention Name(s)
Phenylephrine
Intervention Description
Hypotension (systolic BP <80% of baseline) will be treated with intravenous boluses of phenylephrine 40 μg.
Primary Outcome Measure Information:
Title
cardiac output
Time Frame
from baseline (before spinal injection) until 10 minutes after spinal injection
Secondary Outcome Measure Information:
Title
systolic blood pressure
Time Frame
from baseline (before spinal injection) until 10 minutes after spinal injection
Title
heart rate
Time Frame
from baseline (before spinal injection) until 10 minutes after spinal injection
Title
Apgar score
Time Frame
1 min and 5 min after delivery
Title
Umbilical cord arterial blood pH/BE/Lac
Time Frame
time at delivery
Title
umbilical plasma catecholamine concentration
Time Frame
time at delivery
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
age >=18 years,<=40 years;
height 150-180 cm;
weight 55-80 kg;
full-term gestation (>36 wk and <41 wk)
singleton pregnancy undergoing elective cesarean section under CSEA
Exclusion Criteria:
contraindications to spinal anesthesia;
patients with any complicated pregnancy;
fetal compromise;
need of emergency;
in labor
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Qionghui Zhan, MD
Phone
8621-34506285
Email
zhanqionghui328@163.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Zhenzhou He, MD
Organizational Affiliation
Deparment of Anesthesia,South Campus,Renji Hospital,School of Medicine,Shanghai Jiao Tong University,Shanghai,China
Official's Role
Study Chair
12. IPD Sharing Statement
Plan to Share IPD
No
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Cardiac Output Changes in Cesarean Section
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