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

Sponsor
Mongi Slim Hospital (Other)
Overall Status
Unknown status
CT.gov ID
NCT03719625
Collaborator
(none)
200
Enrollment
2
Arms
4.9
Anticipated Duration (Months)

Study Details

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.

Condition or Disease Intervention/Treatment Phase
Phase 4

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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
200 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
controlled, prospective, randomised trial comparing 2 interventionscontrolled, prospective, randomised trial comparing 2 interventions
Masking:
Single (Participant)
Primary Purpose:
Prevention
Official Title:
Norepinephrine Versus Ephedrin for Prevention of Post Spinal Anesthesia in Cesarean Section
Anticipated Study Start Date :
Jan 2, 2019
Anticipated Primary Completion Date :
May 30, 2019
Anticipated Study Completion Date :
May 30, 2019

Arms and Interventions

Arm Intervention/Treatment
Experimental: norepinephrin group

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

Drug: Norepinephrine
Comparaison of Norepinephrin and Ephedrin for prevention of the post spinal anesthesia in cesarean section
Experimental: Ephedrin group

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

Drug: Ephedrine
Comparaison of Norepinephrin and Ephedrin for prevention of the post spinal anesthesia in cesarean section
Other Names:
  • Ephedrin

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Incidence of post spinal hypotension [during the first 20 minutes after spinal anesthesia]

      decrease of systolic arterial blood pressure > 20% baseline

    Secondary Outcome Measures

    1. Lowest systolic blood pressure [uring the first 20 minutes after spinal anesthesia]

      Lowest systolic blood pressure recorded after spinal anesthesia

    2. Incidence of bradycardia [during the first 20 minutes after spinal anesthesia]

      heart rate<50 beats/min

    3. incidence of nausea and/or vomiting [during the first 20 minutes after spinal anesthesia]

      incidence of nausea and/or vomiting

    4. Apgar score [20min after spinal anesthesia]

      Apgar score at 1 min, 5 min, 10 min

    5. fetal ph [20min after spinal anesthesia]

      fetal ph

    6. fetal blood lactates [20min after spinal anesthesia]

      fetal blood lactates

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    15 Years to 45 Years
    Sexes Eligible for Study:
    Female
    Accepts Healthy Volunteers:
    Yes
    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

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • Mongi Slim Hospital

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Mhamed Sami Mebazaa, Head of the anesthesia intensive care department, Mongi Slim Hospital
    ClinicalTrials.gov Identifier:
    NCT03719625
    Other Study ID Numbers:
    • prophylactic vasopressors
    First Posted:
    Oct 25, 2018
    Last Update Posted:
    Dec 3, 2018
    Last Verified:
    Oct 1, 2018
    Individual Participant Data (IPD) Sharing Statement:
    Undecided
    Plan to Share IPD:
    Undecided
    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
    Additional relevant MeSH terms:
    Hypotension
    Norepinephrine
    Ephedrine

    Study Results

    No Results Posted as of Dec 3, 2018