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

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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

Tracking Information
First Submitted Date  ICMJE October 19, 2018
First Posted Date  ICMJE October 25, 2018
Last Update Posted Date December 3, 2018
Estimated Study Start Date  ICMJE January 2, 2019
Estimated Primary Completion Date May 30, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 23, 2018)
Incidence of post spinal hypotension [ Time Frame: during the first 20 minutes after spinal anesthesia ]
decrease of systolic arterial blood pressure > 20% baseline
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: October 23, 2018)
  • Lowest systolic blood pressure [ Time Frame: uring the first 20 minutes after spinal anesthesia ]
    Lowest systolic blood pressure recorded after spinal anesthesia
  • Incidence of bradycardia [ Time Frame: during the first 20 minutes after spinal anesthesia ]
    heart rate<50 beats/min
  • incidence of nausea and/or vomiting [ Time Frame: during the first 20 minutes after spinal anesthesia ]
    incidence of nausea and/or vomiting
  • Apgar score [ Time Frame: 20min after spinal anesthesia ]
    Apgar score at 1 min, 5 min, 10 min
  • fetal ph [ Time Frame: 20min after spinal anesthesia ]
    fetal ph
  • fetal blood lactates [ Time Frame: 20min after spinal anesthesia ]
    fetal blood lactates
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Norepinephrine Versus Ephedrin for Prevention of Post Spinal Anesthesia in Cesarean Section
Official Title  ICMJE Norepinephrine Versus Ephedrin for Prevention of Post Spinal Anesthesia in Cesarean Section
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:
controlled, prospective, randomised trial comparing 2 interventions
Masking: Single (Participant)
Primary Purpose: Prevention
Condition  ICMJE
  • Maternal Hypotension Syndrome
  • Cesarean
Intervention  ICMJE
  • Drug: Ephedrine
    Comparaison of Norepinephrin and Ephedrin for prevention of the post spinal anesthesia in cesarean section
    Other Name: Ephedrin
  • Drug: Norepinephrine
    Comparaison of Norepinephrin and Ephedrin for prevention of the post spinal anesthesia in cesarean section
Study Arms  ICMJE
  • 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
    Intervention: Drug: Norepinephrine
  • 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
    Intervention: Drug: Ephedrine
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Not yet recruiting
Estimated Enrollment  ICMJE
 (submitted: October 23, 2018)
200
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE May 30, 2019
Estimated Primary Completion Date May 30, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Gender Based Eligibility: Yes
Gender Eligibility Description: this study is exclusively including paturients undergoing cesarean section
Ages  ICMJE 15 Years to 45 Years   (Child, Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE
Contact: Asma Ben Souissi, assistant professor 0021698336883 bsouissiasma@gmail.com
Contact: Mhamed Sami Mebazaa, Professor 0021622252589 msmebazaa@gmail.com
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03719625
Other Study ID Numbers  ICMJE prophylactic vasopressors
Has Data Monitoring Committee No
U.S. FDA-regulated Product
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
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Responsible Party Mhamed Sami Mebazaa, Mongi Slim Hospital
Study Sponsor  ICMJE Mongi Slim Hospital
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Mongi Slim Hospital
Verification Date October 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP