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

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.

Study Overview

• Status: Unknown
• Conditions: Cesarean; Maternal Hypotension Syndrome
• Intervention / Treatment: Drug: Norepinephrine; Drug: Ephedrine

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: Interventional
• Enrollment (Anticipated): 200
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Asma Ben Souissi, assistant professor; Phone Number: 0021698336883; Email: bsouissiasma@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 15 years to 45 years (ADULT, CHILD)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: PREVENTION
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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	Drug: Norepinephrine; Comparaison of Norepinephrin and Ephedrin for prevention of the post spinal anesthesia in cesarean section
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	Drug: Ephedrine; Comparaison of Norepinephrin and Ephedrin for prevention of the post spinal anesthesia in cesarean section; Other Names: Ephedrin

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Mongi Slim Hospital

Study record dates

Study Major Dates

• Study Start (ANTICIPATED): January 2, 2019
• Primary Completion (ANTICIPATED): May 30, 2019
• Study Completion (ANTICIPATED): May 30, 2019

Study Registration Dates

• First Submitted: October 19, 2018
• First Submitted That Met QC Criteria: October 23, 2018
• First Posted (ACTUAL): October 25, 2018

Study Record Updates

• Last Update Posted (ACTUAL): December 3, 2018
• Last Update Submitted That Met QC Criteria: November 30, 2018
• Last Verified: October 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Hypotension; Physiological Effects of Drugs; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Autonomic Agents; Peripheral Nervous System Agents; Adrenergic alpha-Agonists; Adrenergic Agonists; Central Nervous System Stimulants; Sympathomimetics; Vasoconstrictor Agents; Norepinephrine; Ephedrine
• Other Study ID Numbers: prophylactic vasopressors

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• 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