search
Back to results

Prophylactic Norepinephrine and Phenylephrine Infusion for Hemodynamic Effects in Patients With Preeclampsia

Primary Purpose

Hemodynamic Instability

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Phenylephrine
Norepinephrine
Sponsored by
General Hospital of Ningxia Medical University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hemodynamic Instability focused on measuring Norepinephrine, Phenylephrine, Hemodynamic effects, Preeclampsia, Cesarean section

Eligibility Criteria

18 Years - 45 Years (Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

  • 18-45 years
  • Primipara or multipara
  • Singleton pregnancy ≥32 weeks
  • American Society of Anesthesiologists physical status classification II to III
  • Scheduled for cesarean section under spinal anesthesia

Exclusion Criteria:

  • Baseline blood pressure ≥180 mmHg
  • Body height < 150 cm
  • Body weight > 100 kg or body mass index (BMI) ≥ 40 kg/m2
  • Eclampsia or chronic hypertension
  • Hemoglobin < 7g/dl
  • Fetal distress, or known fetal developmental anomaly

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Experimental

    Arm Label

    Phenylephrine group

    Norepinephrine group

    Arm Description

    Phenylephrine infusion simultaneous with spinal anesthesia

    Norepinephrine infusion simultaneous with spinal anesthesia

    Outcomes

    Primary Outcome Measures

    Cardiac output (CO)
    Evaluated by the VIGILCO monitoring system
    Stroke volume (SV)
    Evaluated by the VIGILCO monitoring system
    Systemic vascular resistance (SVR)
    Evaluated by the VIGILCO monitoring system

    Secondary Outcome Measures

    Overall stability of systolic blood pressure control versus baseline
    Evaluated by performance error (PE)
    Overall stability of heart rate control versus baseline
    Evaluated by performance error (PE)
    The incidence of post-spinal anesthesia hypotension
    Systolic blood pressure (SBP) < 80% of the baseline
    The incidence of severe post-spinal anesthesia hypotension.
    Systolic blood pressure (SBP) < 60% of the baseline
    The incidence of hypertension.
    Systolic blood pressure (SBP) >120% of the baseline.
    The incidence of bradycardia.
    Heart rate < 60 beats/min.
    The incidence of nausea and vomiting.
    Presence of nausea and vomiting in patients after spinal anesthesia
    pH
    From umbilical arterial blood gases.
    Partial pressure of oxygen (PO2)
    From umbilical arterial blood gases.
    Base excess (BE)
    From umbilical arterial blood gases.
    APGAR score
    A= Appearance P=Pulse G=Grimace A=Attitude R=Respiration
    APGAR score
    A= Appearance P=Pulse G=Grimace A=Attitude R=Respiration

    Full Information

    First Posted
    September 2, 2021
    Last Updated
    September 5, 2021
    Sponsor
    General Hospital of Ningxia Medical University
    search

    1. Study Identification

    Unique Protocol Identification Number
    NCT05035498
    Brief Title
    Prophylactic Norepinephrine and Phenylephrine Infusion for Hemodynamic Effects in Patients With Preeclampsia
    Official Title
    Comparison of Prophylactic Norepinephrine and Phenylephrine Infusion for Hemodynamic Effects in Patients With Preeclampsia During Cesarean Section: a Randomized, Controlled Trial
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    September 2021
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    January 1, 2023 (Anticipated)
    Primary Completion Date
    December 31, 2023 (Anticipated)
    Study Completion Date
    December 31, 2023 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    General Hospital of Ningxia Medical University

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No

    5. Study Description

    Brief Summary
    The purpose of this study is to investigate the maternal cardiac output response to prophylactic norepinephrine and phenylephrine infusion for postspinal anesthesia hypotension in parturients with preeclampsia undergoing cesarean section.
    Detailed Description
    Preeclampsia, which affects 5% to 7% of parturients, is a significant cause of maternal and neonatal morbidity and mortality. Because of constricted myometrial spiral arteries with exaggerated vasomotor responsiveness, though blood pressure in parturients with preeclampsia are apparently higher than healthy parturients, placental hypoperfusion is more common. Spinal anesthesia is still the preferred mode of anesthesia in parturients with preeclampsia for cesarean section. In preeclampsia parturients, spinal anesthesia improve intervillous blood flow (provided that hypotension is avoided) which contribute to increase placental perfusion. Even so, 17-26% parturients with preeclampsia experienced postspinal anesthesia hypotension due to the extensive sympathetic block that occurred with spinal anesthesia. As a potential substitute drug for phenylephrine and ephedrine, norepinephrine has gained traction for use in parturients undergoing cesarean section. However, hemodynamic effects of the prophylactic norepinephrine infusion is still unknown. The purpose of this study is to investigate the maternal cardiac output response to prophylactic norepinephrine and phenylephrine infusion for postspinal anesthesia hypotension in parturients with preeclampsia undergoing cesarean section.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Hemodynamic Instability
    Keywords
    Norepinephrine, Phenylephrine, Hemodynamic effects, Preeclampsia, Cesarean section

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantCare Provider
    Allocation
    Randomized
    Enrollment
    72 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Phenylephrine group
    Arm Type
    Active Comparator
    Arm Description
    Phenylephrine infusion simultaneous with spinal anesthesia
    Arm Title
    Norepinephrine group
    Arm Type
    Experimental
    Arm Description
    Norepinephrine infusion simultaneous with spinal anesthesia
    Intervention Type
    Drug
    Intervention Name(s)
    Phenylephrine
    Other Intervention Name(s)
    Vasopressors
    Intervention Description
    A maintenance dose of phenylephrine (0.625 μg/kg/min) infusion simultaneous with subarachnoid block
    Intervention Type
    Drug
    Intervention Name(s)
    Norepinephrine
    Other Intervention Name(s)
    Vasopressors
    Intervention Description
    A maintenance dose of norepinephrine (0.05 μg/kg/min) infusion simultaneous with subarachnoid block
    Primary Outcome Measure Information:
    Title
    Cardiac output (CO)
    Description
    Evaluated by the VIGILCO monitoring system
    Time Frame
    1-30 minutes after spinal anesthesia
    Title
    Stroke volume (SV)
    Description
    Evaluated by the VIGILCO monitoring system
    Time Frame
    1-30 minutes after spinal anesthesia
    Title
    Systemic vascular resistance (SVR)
    Description
    Evaluated by the VIGILCO monitoring system
    Time Frame
    1-30 minutes after spinal anesthesia
    Secondary Outcome Measure Information:
    Title
    Overall stability of systolic blood pressure control versus baseline
    Description
    Evaluated by performance error (PE)
    Time Frame
    1-30 minutes after spinal anesthesia
    Title
    Overall stability of heart rate control versus baseline
    Description
    Evaluated by performance error (PE)
    Time Frame
    1-30 minutes after spinal anesthesia
    Title
    The incidence of post-spinal anesthesia hypotension
    Description
    Systolic blood pressure (SBP) < 80% of the baseline
    Time Frame
    1-30 minutes after spinal anesthesia.
    Title
    The incidence of severe post-spinal anesthesia hypotension.
    Description
    Systolic blood pressure (SBP) < 60% of the baseline
    Time Frame
    1-30 minutes after spinal anesthesia.
    Title
    The incidence of hypertension.
    Description
    Systolic blood pressure (SBP) >120% of the baseline.
    Time Frame
    1-30 minutes after spinal anesthesia
    Title
    The incidence of bradycardia.
    Description
    Heart rate < 60 beats/min.
    Time Frame
    1-30 minutes after spinal anesthesia
    Title
    The incidence of nausea and vomiting.
    Description
    Presence of nausea and vomiting in patients after spinal anesthesia
    Time Frame
    1-30 minutes after spinal anesthesia
    Title
    pH
    Description
    From umbilical arterial blood gases.
    Time Frame
    Immediately after delivery
    Title
    Partial pressure of oxygen (PO2)
    Description
    From umbilical arterial blood gases.
    Time Frame
    Immediately after delivery
    Title
    Base excess (BE)
    Description
    From umbilical arterial blood gases.
    Time Frame
    Immediately after delivery
    Title
    APGAR score
    Description
    A= Appearance P=Pulse G=Grimace A=Attitude R=Respiration
    Time Frame
    1 min after delivery
    Title
    APGAR score
    Description
    A= Appearance P=Pulse G=Grimace A=Attitude R=Respiration
    Time Frame
    5 min after delivery

    10. Eligibility

    Sex
    Female
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    45 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: 18-45 years Primipara or multipara Singleton pregnancy ≥32 weeks American Society of Anesthesiologists physical status classification II to III Scheduled for cesarean section under spinal anesthesia Exclusion Criteria: Baseline blood pressure ≥180 mmHg Body height < 150 cm Body weight > 100 kg or body mass index (BMI) ≥ 40 kg/m2 Eclampsia or chronic hypertension Hemoglobin < 7g/dl Fetal distress, or known fetal developmental anomaly
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Xinli Ni, Dr.
    Phone
    86-951-674-3252
    Email
    xinlini6@nyfy.com.cn
    First Name & Middle Initial & Last Name or Official Title & Degree
    Yi Chen, M.D.
    Phone
    86-951-674-3252
    Email
    czzyxgp@163.com
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Xinli Ni, Dr.
    Organizational Affiliation
    General Hospital of Ningxia Medical University
    Official's Role
    Study Chair

    12. IPD Sharing Statement

    Learn more about this trial

    Prophylactic Norepinephrine and Phenylephrine Infusion for Hemodynamic Effects in Patients With Preeclampsia

    We'll reach out to this number within 24 hrs