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The Potency of Prophylactic Norepinephrine and Phenylephrine Boluses for Postspinal Anesthesia Hypotension

Primary Purpose

Adverse Effect

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 Adverse Effect focused on measuring Norepinephrine, Phenylephrine, Postspinal anesthesia hypotension, 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

    Prophylactic phenylephrine bolus simultaneous with spinal anesthesia

    Prophylactic norepinephrine bolus simultaneous with spinal anesthesia

    Outcomes

    Primary Outcome Measures

    The dose that would be effective in preventing postspinal anesthesia hypotension in 50% (effective dose, ED 50) and 90% (ED90) of patients
    Systolic blood pressure (SBP) < 80% of the baseline

    Secondary Outcome Measures

    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 bradycardia.
    Heart rate < 60 beats/min.
    The incidence of nausea and vomiting.
    Presence of nausea and vomiting in patients after spinal anesthesia
    The incidence of hypertension.
    Systolic blood pressure (SBP) >120% of the baseline.
    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
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05035472
    Brief Title
    The Potency of Prophylactic Norepinephrine and Phenylephrine Boluses for Postspinal Anesthesia Hypotension
    Official Title
    Comparison of the Potency of Prophylactic Norepinephrine and Phenylephrine Boluses for Postspinal Anesthesia Hypotension in Patients With Severe Preeclampsia During Caesarean Section
    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 potency between prophylactic norepinephrine and phenylephrine boluses for postspinal anesthesia hypotension in patients with severe preeclampsia during caesarean section.
    Detailed Description
    Preeclampsia, which affects 5% to 7% of patients, 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 patients with preeclampsia are apparently higher than healthy patients, placental hypoperfusion is more common. Spinal anesthesia is still the preferred mode of anesthesia in patients with preeclampsia for cesarean section. In preeclampsia patients, spinal anesthesia improve intervillous blood flow (provided that hypotension is avoided) which contribute to increase placental perfusion. Even so, 17-26% patients 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 patients undergoing cesarean section. However, the ED50 (prevent postspinal hypotension in 50% of patients) and ED90 of prophylactic norepinephrine bolus is still unknown. The purpose of this study is to investigate the potency between prophylactic norepinephrine and phenylephrine boluses for postspinal anesthesia hypotension in patients with severe preeclampsia during caesarean section.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Adverse Effect
    Keywords
    Norepinephrine, Phenylephrine, Postspinal anesthesia hypotension, Preeclampsia, Cesarean section

    7. Study Design

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

    8. Arms, Groups, and Interventions

    Arm Title
    Phenylephrine group
    Arm Type
    Active Comparator
    Arm Description
    Prophylactic phenylephrine bolus simultaneous with spinal anesthesia
    Arm Title
    Norepinephrine group
    Arm Type
    Experimental
    Arm Description
    Prophylactic norepinephrine bolus simultaneous with spinal anesthesia
    Intervention Type
    Drug
    Intervention Name(s)
    Phenylephrine
    Other Intervention Name(s)
    Vasopressors
    Intervention Description
    An initial prophylactic bolus dose of phenylephrine (37.5μg) simultaneous with spinal anesthesia. If the patient did not respond adequately to the current dose (SBP decreased to < 80% of baseline), the dose was considered to have failed and the subsequent dose for the following patient was increased to the next higher dose level. The dose administered to subsequent patients varied by increments or decrements of 12.5 μg according to the responses of previous patients according to the up-down sequential allocation.
    Intervention Type
    Drug
    Intervention Name(s)
    Norepinephrine
    Other Intervention Name(s)
    Vasopressors
    Intervention Description
    An initial prophylactic bolus dose of norepinephrine (3μg) simultaneous with spinal anesthesia. The dose administered to subsequent patients varied by increments or decrements of 1 μg according to the responses of previous patients according to the up-down sequential allocation.
    Primary Outcome Measure Information:
    Title
    The dose that would be effective in preventing postspinal anesthesia hypotension in 50% (effective dose, ED 50) and 90% (ED90) of patients
    Description
    Systolic blood pressure (SBP) < 80% of the baseline
    Time Frame
    1-15 minutes after spinal anesthesia
    Secondary Outcome Measure Information:
    Title
    The incidence of post-spinal anesthesia hypotension
    Description
    Systolic blood pressure (SBP) < 80% of the baseline
    Time Frame
    1-15 minutes after spinal anesthesia
    Title
    The incidence of severe post-spinal anesthesia hypotension.
    Description
    Systolic blood pressure (SBP) < 60% of the baseline
    Time Frame
    1-15 minutes after spinal anesthesia
    Title
    The incidence of bradycardia.
    Description
    Heart rate < 60 beats/min.
    Time Frame
    1-15 minutes after spinal anesthesia
    Title
    The incidence of nausea and vomiting.
    Description
    Presence of nausea and vomiting in patients after spinal anesthesia
    Time Frame
    1-15 minutes after spinal anesthesia
    Title
    The incidence of hypertension.
    Description
    Systolic blood pressure (SBP) >120% of the baseline.
    Time Frame
    1-15 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

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    The Potency of Prophylactic Norepinephrine and Phenylephrine Boluses for Postspinal Anesthesia Hypotension

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