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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Maternal Hypotension Syndrome, Cesarean

Intervention / Treatment
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* Drug: Ephedrine
* Drug: Norepinephrine


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 15 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: controlled, prospective, randomised trial comparing 2 interventions
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: norepinephrin group<br>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<br>* Comparaison of Norepinephrin and Ephedrin for prevention of the post spinal anesthesia in cesarean section<br>|
| Experimental: Ephedrin group<br>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<br>* Comparaison of Norepinephrin and Ephedrin for prevention of the post spinal anesthesia in cesarean section<br>* Other names: Ephedrin;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of post spinal hypotension | decrease of systolic arterial blood pressure > 20% baseline | during the first 20 minutes after spinal anesthesia | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Lowest systolic blood pressure | Lowest systolic blood pressure recorded after spinal anesthesia | uring the first 20 minutes after spinal anesthesia | 
| Incidence of bradycardia | heart rate<50 beats/min | during the first 20 minutes after spinal anesthesia | 
| incidence of nausea and/or vomiting | incidence of nausea and/or vomiting | during the first 20 minutes after spinal anesthesia | 
| Apgar score | Apgar score at 1 min, 5 min, 10 min | 20min after spinal anesthesia | 
| fetal ph | fetal ph | 20min after spinal anesthesia | 
| fetal blood lactates | fetal blood lactates | 20min after spinal anesthesia |