Clinical trial NCT03719625: Norepinephrine Versus Ephedrin for Prevention of Post Spinal Anesthesia in Cesarean Section
Official title: Norepinephrine Versus Ephedrin for Prevention of Post Spinal Anesthesia in Cesarean Section
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Maternal Hypotension Syndrome
Cesarean
Lead sponsor: Mongi Slim Hospital
Sponsor class: OTHER
First posted: 2018-10-25
Enrollment: 200
Sex: FEMALE
Minimum age (years): 15
Maximum age (years): 45
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: controlled, prospective, randomised trial comparing 2 interventions
Primary purpose: PREVENTION

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.

Eligibility 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

Primary outcomes:
measure: Incidence of post spinal hypotension
timeFrame: during the first 20 minutes after spinal anesthesia
Secondary outcomes:
measure: Lowest systolic blood pressure
timeFrame: uring the first 20 minutes after spinal anesthesia
measure: Incidence of bradycardia
timeFrame: during the first 20 minutes after spinal anesthesia
measure: incidence of nausea and/or vomiting
timeFrame: during the first 20 minutes after spinal anesthesia
measure: Apgar score
timeFrame: 20min after spinal anesthesia
measure: fetal ph
timeFrame: 20min after spinal anesthesia
measure: fetal blood lactates
timeFrame: 20min after spinal anesthesia
Other outcomes:
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