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

Mongi Slim Hospital

Status and phase: Unknown; Phase 4

Conditions: Cesarean; Maternal Hypotension Syndrome

Treatments: Drug: Ephedrine; Drug: Norepinephrine

Study type: Interventional

Funder types: Other

Identifiers

NCT03719625

prophylactic vasopressors

Details and patient eligibility

About

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.

Full 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.

Enrollment: 200 estimated patients

Sex: Female

Ages: 15 to 45 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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200 participants in 2 patient groups

norepinephrin group

Experimental group

Description:

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

Treatment:

Drug: Norepinephrine

Ephedrin group

Experimental group

Description:

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

Treatment:

Drug: Ephedrine