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

Phase 4

• Conditions: Cesarean; Maternal Hypotension Syndrome
• Interventions: Drug: Norepinephrine; Drug: Ephedrine

• Registration Number: NCT03719625
• Lead Sponsor: 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.

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 Timeline

• Status Verified: 2018-10
• Study First Submitted: 2018-10-19
• Study First Submitted QC: 2018-10-23
• Study First Posted: 2018-10-25
• Last Update Submitted: 2018-11-30
• Last Update Posted: 2018-12-03
• Study Start: 2019-01-02
• Primary Completion: 2019-05-30
• Study Completion: 2019-05-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 200

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
norepinephrin group	Norepinephrine	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
Ephedrin group	Ephedrine	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

Primary Outcome Measures

Name	Time	Method
Incidence of post spinal hypotension	during the first 20 minutes after spinal anesthesia	decrease of systolic arterial blood pressure \> 20% baseline

Secondary Outcome Measures

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