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Norepinephrine Versus Ephedrine in Treatment of Hypotension During Spinal Anesthesia for Caesarean Section

Primary Purpose

Hypotension, Vasopressors, Cesarean Section Complications

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Norepinephrine
Ephedrine
Sponsored by
Mongi Slim Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Hypotension

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleAccepts Healthy Volunteers

Inclusion Criteria:

  • Fully term parturients
  • Caesarean section under spinal anesthesia
  • ASA status I or II

Exclusion Criteria:

  • Severe cardiac disease
  • Cardiac arrhythmia

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Active Comparator

    Arm Label

    Norepinephrine group

    Ephedrine group

    Arm Description

    Treatment of the postspinal anesthesia hypotension by administrating 5 mcg of Norepinephrine intravenously every 3 min until normal systolic blood pressure

    Management of the post spinal hypotension by administrating 6 mg of Ephedrine intravenously every 3 min

    Outcomes

    Primary Outcome Measures

    number of injections
    number of injections required to manage the post spinal hypotension

    Secondary Outcome Measures

    Full Information

    First Posted
    May 19, 2017
    Last Updated
    May 19, 2017
    Sponsor
    Mongi Slim Hospital
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03163407
    Brief Title
    Norepinephrine Versus Ephedrine in Treatment of Hypotension During Spinal Anesthesia for Caesarean Section
    Official Title
    Norepinephrine Versus Ephedrine for Treatment of Hypotension During Spinal Anesthesia for Caesarean Section
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    May 2017
    Overall Recruitment Status
    Completed
    Study Start Date
    July 1, 2016 (Actual)
    Primary Completion Date
    December 31, 2016 (Actual)
    Study Completion Date
    January 31, 2017 (Actual)

    3. Sponsor/Collaborators

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

    4. Oversight

    5. Study Description

    Brief Summary
    Prospective, randomized study, including full term parturients scheduled for caesarean section under spinal anesthesia. Spinal anesthesia was performed in sitting position with a 25 G spinal needle and all patients received 15 ml/kg of crystalloid intravenously during the spinal block. Baseline hemodynamics: heart rate, systolic and diastolic blood pressure were recorded before spinal anesthesia and intraoperatively. Postspinal hypotension, defined as decrease of Systolic blood pressure>20% from the baseline value, was managed using Ephedrine increments 6 mg/3min in patients of GE group or by 5 mcg Norepinephrine/3min for the patients of GN group. Intraoperative hemodynamic data of the 2 groups were compared.
    Detailed Description
    Prospective, randomized study including full term parturients scheduled for caesarean section under spinal anesthesia. All patients were ASA status I/II and patients with arrhythmia were excluded. Spinal anesthesia was performed in sitting position at L3-4 or L4-5. A 25 G spinal needle was used for intrathecal injection of 8 mg of hyperbaric bupivacaine, 2.5 mcg sufentanil and 100 mcg morphine. All patients received 15 ml/kg of crystalloids intravenously during the spinal block. Patients were positioned in left lateral tilt position. Baseline hemodynamics; HR, systolic (SBP) and diastolic blood pressure (DPB) were recorded before spinal anesthesia and intraoperatively (every 2 min). Post anesthesia hypotension was defined as decrease of SBP>20% from the baseline value. If hypotension occurred, patients were randomized into 2 groups: GE group in which hypotension were managed using ephedrine increments of 6 mg Ephedrine every 3 min until correction of SBP GN group: patients of this group received 5mcg of Norepinephrine/3 min demographic and hemodynamic data of the two groups were compared.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Hypotension, Vasopressors, Cesarean Section Complications, Anesthesia Complication

    7. Study Design

    Primary Purpose
    Supportive Care
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    Participant
    Allocation
    Randomized
    Enrollment
    110 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Norepinephrine group
    Arm Type
    Active Comparator
    Arm Description
    Treatment of the postspinal anesthesia hypotension by administrating 5 mcg of Norepinephrine intravenously every 3 min until normal systolic blood pressure
    Arm Title
    Ephedrine group
    Arm Type
    Active Comparator
    Arm Description
    Management of the post spinal hypotension by administrating 6 mg of Ephedrine intravenously every 3 min
    Intervention Type
    Drug
    Intervention Name(s)
    Norepinephrine
    Intervention Description
    Treatment of the postspinal anesthesia hypotension by administrating 5 mcg of Norepinephrine intravenously every 3 min until normal systolic blood pressure
    Intervention Type
    Drug
    Intervention Name(s)
    Ephedrine
    Intervention Description
    Management of the post spinal hypotension by administrating 6 mg of Ephedrine intravenously every 3 min
    Primary Outcome Measure Information:
    Title
    number of injections
    Description
    number of injections required to manage the post spinal hypotension
    Time Frame
    number of injections required in the first hour

    10. Eligibility

    Sex
    Female
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: Fully term parturients Caesarean section under spinal anesthesia ASA status I or II Exclusion Criteria: Severe cardiac disease Cardiac arrhythmia

    12. IPD Sharing Statement

    Plan to Share IPD
    No

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    Norepinephrine Versus Ephedrine in Treatment of Hypotension During Spinal Anesthesia for Caesarean Section

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