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Norepinephrine Versus Ephedrin for Prevention of Post Spinal Anesthesia in Cesarean Section

Primary Purpose

Maternal Hypotension Syndrome, Cesarean

Status
Unknown status
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
Ephedrine
Norepinephrine
Sponsored by
Mongi Slim Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Maternal Hypotension Syndrome

Eligibility Criteria

15 Years - 45 Years (Child, Adult)FemaleAccepts Healthy Volunteers

Inclusion Criteria:

  • full termed parturients scheduled for elective or semi urgent cesarean section under spinal anesthesia
  • AGE>15 years
  • ASA II status
  • No history of hypertension, preeclampsia or cardiopathy
  • BMI<40

Exclusion Criteria:

  • cesarean section under genearl anesthesia or epidural analgesia during labor

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Experimental

    Arm Label

    norepinephrin group

    Ephedrin group

    Arm Description

    The patients of this group will recieve 0.5 micro gr/kg of norepinephin intravenously, the infusion will start during the intrathecal injection and during 10 minutes

    The patients of this group will recieve 0,3mg/kg of Ephedrin intravenously, the infusion will start during the intrathecal injection and during 10 minutes

    Outcomes

    Primary Outcome Measures

    Incidence of post spinal hypotension
    decrease of systolic arterial blood pressure > 20% baseline

    Secondary Outcome Measures

    Lowest systolic blood pressure
    Lowest systolic blood pressure recorded after spinal anesthesia
    Incidence of bradycardia
    heart rate<50 beats/min
    incidence of nausea and/or vomiting
    incidence of nausea and/or vomiting
    Apgar score
    Apgar score at 1 min, 5 min, 10 min
    fetal ph
    fetal ph
    fetal blood lactates
    fetal blood lactates

    Full Information

    First Posted
    October 19, 2018
    Last Updated
    November 30, 2018
    Sponsor
    Mongi Slim Hospital
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03719625
    Brief Title
    Norepinephrine Versus Ephedrin for Prevention of Post Spinal Anesthesia in Cesarean Section
    Official Title
    Norepinephrine Versus Ephedrin for Prevention of Post Spinal Anesthesia in Cesarean Section
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    October 2018
    Overall Recruitment Status
    Unknown status
    Study Start Date
    January 2, 2019 (Anticipated)
    Primary Completion Date
    May 30, 2019 (Anticipated)
    Study Completion Date
    May 30, 2019 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Mongi Slim Hospital

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Product Manufactured in and Exported from the U.S.
    No
    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    Spinal anesthesia is still the gold standard anesthetic method for elective and urgent cesarean section, the post spinal hypotension remains the most frequent complication of this procedure and is still responsible of considerable maternel and fetal morbidity. It is recommanded to prevent this post spinal hypotension with fluid coloading and prophylactic vasopressors administration. The aim of this study is to compare the efficency and the safety of norepinephrin and ephedrin prophylactic administration to reduce the incidence of post spinal hypotension in cesarean section.
    Detailed Description
    Spinal anesthesia is still the gold standard anesthetic method for elective and urgent cesarean section, the post spinal hypotension remains the most frequent complication of this procedure and is still responsible of considerable maternel and fetal morbidity. It is recommanded to prevent this post spinal hypotension with fluid coloading and prophylactic vasopressors administration. The prophylactic use of norepinephrin and phenylephrin has been validated by several studies, but few data are published concerning the comparaison between norepinephrin and ephedrine as preventive vasopressors in cesarean section; these molecules act on alpha and beta adrenergic receptors and could provide better maternal hemodynamics in parturients undergoing cesarean section under spinal anesthesia. The aim of this study is to compare the efficency and the safety of norepinephrin and ephedrin prophylactic administration to reduce the incidence of post spinal hypotension in cesarean section.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Maternal Hypotension Syndrome, Cesarean

    7. Study Design

    Primary Purpose
    Prevention
    Study Phase
    Phase 4
    Interventional Study Model
    Parallel Assignment
    Model Description
    controlled, prospective, randomised trial comparing 2 interventions
    Masking
    Participant
    Allocation
    Randomized
    Enrollment
    200 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    norepinephrin group
    Arm Type
    Experimental
    Arm Description
    The patients of this group will recieve 0.5 micro gr/kg of norepinephin intravenously, the infusion will start during the intrathecal injection and during 10 minutes
    Arm Title
    Ephedrin group
    Arm Type
    Experimental
    Arm Description
    The patients of this group will recieve 0,3mg/kg of Ephedrin intravenously, the infusion will start during the intrathecal injection and during 10 minutes
    Intervention Type
    Drug
    Intervention Name(s)
    Ephedrine
    Other Intervention Name(s)
    Ephedrin
    Intervention Description
    Comparaison of Norepinephrin and Ephedrin for prevention of the post spinal anesthesia in cesarean section
    Intervention Type
    Drug
    Intervention Name(s)
    Norepinephrine
    Intervention Description
    Comparaison of Norepinephrin and Ephedrin for prevention of the post spinal anesthesia in cesarean section
    Primary Outcome Measure Information:
    Title
    Incidence of post spinal hypotension
    Description
    decrease of systolic arterial blood pressure > 20% baseline
    Time Frame
    during the first 20 minutes after spinal anesthesia
    Secondary Outcome Measure Information:
    Title
    Lowest systolic blood pressure
    Description
    Lowest systolic blood pressure recorded after spinal anesthesia
    Time Frame
    uring the first 20 minutes after spinal anesthesia
    Title
    Incidence of bradycardia
    Description
    heart rate<50 beats/min
    Time Frame
    during the first 20 minutes after spinal anesthesia
    Title
    incidence of nausea and/or vomiting
    Description
    incidence of nausea and/or vomiting
    Time Frame
    during the first 20 minutes after spinal anesthesia
    Title
    Apgar score
    Description
    Apgar score at 1 min, 5 min, 10 min
    Time Frame
    20min after spinal anesthesia
    Title
    fetal ph
    Description
    fetal ph
    Time Frame
    20min after spinal anesthesia
    Title
    fetal blood lactates
    Description
    fetal blood lactates
    Time Frame
    20min after spinal anesthesia

    10. Eligibility

    Sex
    Female
    Gender Based
    Yes
    Gender Eligibility Description
    this study is exclusively including paturients undergoing cesarean section
    Minimum Age & Unit of Time
    15 Years
    Maximum Age & Unit of Time
    45 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: full termed parturients scheduled for elective or semi urgent cesarean section under spinal anesthesia AGE>15 years ASA II status No history of hypertension, preeclampsia or cardiopathy BMI<40 Exclusion Criteria: cesarean section under genearl anesthesia or epidural analgesia during labor
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Asma Ben Souissi, assistant professor
    Phone
    0021698336883
    Email
    bsouissiasma@gmail.com
    First Name & Middle Initial & Last Name or Official Title & Degree
    Mhamed Sami Mebazaa, Professor
    Phone
    0021622252589
    Email
    msmebazaa@gmail.com

    12. IPD Sharing Statement

    Plan to Share IPD
    Undecided

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    Norepinephrine Versus Ephedrin for Prevention of Post Spinal Anesthesia in Cesarean Section

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