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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
RenJi Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cardiac Output,Low focused on measuring cardiac output, norepinephrin, cesarean section

Eligibility Criteria

18 Years - 40 Years (Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

  1. age >=18 years,<=40 years;
  2. height 150-180 cm;
  3. weight 55-80 kg;
  4. full-term gestation (>36 wk and <41 wk)
  5. singleton pregnancy undergoing elective cesarean section under CSEA

Exclusion Criteria:

  1. contraindications to spinal anesthesia;
  2. patients with any complicated pregnancy;
  3. fetal compromise;
  4. need of emergency;
  5. 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

    First Posted
    April 29, 2016
    Last Updated
    May 2, 2016
    Sponsor
    RenJi Hospital
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    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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