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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03719625
Recruitment Status : Not yet recruiting
First Posted : October 25, 2018
Last Update Posted : December 3, 2018
Sponsor:
Information provided by (Responsible Party):
Mhamed Sami Mebazaa, Mongi Slim Hospital

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
Maternal Hypotension Syndrome Cesarean Drug: Ephedrine Drug: Norepinephrine 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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: controlled, 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
Estimated Study Start Date : January 2, 2019
Estimated Primary Completion Date : May 30, 2019
Estimated Study Completion Date : May 30, 2019

Resource links provided by the National Library of Medicine


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 Name: Ephedrin




Primary Outcome Measures :
  1. Incidence of post spinal hypotension [ Time Frame: during the first 20 minutes after spinal anesthesia ]
    decrease of systolic arterial blood pressure > 20% baseline


Secondary Outcome Measures :
  1. Lowest systolic blood pressure [ Time Frame: uring the first 20 minutes after spinal anesthesia ]
    Lowest systolic blood pressure recorded after spinal anesthesia

  2. Incidence of bradycardia [ Time Frame: during the first 20 minutes after spinal anesthesia ]
    heart rate<50 beats/min

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

  4. Apgar score [ Time Frame: 20min after spinal anesthesia ]
    Apgar score at 1 min, 5 min, 10 min

  5. fetal ph [ Time Frame: 20min after spinal anesthesia ]
    fetal ph

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



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Ages Eligible for Study:   15 Years to 45 Years   (Child, Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Gender Eligibility Description:   this study is exclusively including paturients undergoing cesarean section
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03719625


Contacts
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Contact: Asma Ben Souissi, assistant professor 0021698336883 bsouissiasma@gmail.com
Contact: Mhamed Sami Mebazaa, Professor 0021622252589 msmebazaa@gmail.com

Sponsors and Collaborators
Mongi Slim Hospital

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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: October 25, 2018    Key Record Dates
Last Update Posted: December 3, 2018
Last Verified: October 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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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:
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Hypotension
Vascular Diseases
Cardiovascular Diseases
Norepinephrine
Ephedrine
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Adrenergic alpha-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Sympathomimetics
Autonomic Agents
Peripheral Nervous System Agents
Vasoconstrictor Agents
Central Nervous System Stimulants