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

NCT03719625 | Unknown Phase 4

• 1 other identifier: prophylactic vasopressors
• Study Type: interventional
• Target: 200
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Maternal Hypotension Syndrome; Cesarean

Outcome Measures

Primary Outcomes (1)

• Incidence of post spinal hypotension

  decrease of systolic arterial blood pressure \> 20% baseline

  during the first 20 minutes after spinal anesthesia

Secondary Outcomes (6)

• Lowest systolic blood pressure

  uring the first 20 minutes after spinal anesthesia

• Incidence of bradycardia

  during the first 20 minutes after spinal anesthesia

• incidence of nausea and/or vomiting

  during the first 20 minutes after spinal anesthesia

• Apgar score

  20min after spinal anesthesia

• fetal ph

  20min after spinal anesthesia

Study Arms (2)

norepinephrin group

EXPERIMENTAL

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

Ephedrin group

EXPERIMENTAL

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

Interventions

Ephedrine DRUG

Comparaison of Norepinephrin and Ephedrin for prevention of the post spinal anesthesia in cesarean section

Also known as: Ephedrin

Ephedrin group

Norepinephrine DRUG

Comparaison of Norepinephrin and Ephedrin for prevention of the post spinal anesthesia in cesarean section

norepinephrin group

Eligibility Criteria

• Age: 15 Years - 45 Years
• Gender Eligibility Details: this study is exclusively including paturients undergoing cesarean section
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• cesarean section under genearl anesthesia or epidural analgesia during labor

Sponsors & Collaborators

• Mongi Slim Hospital: lead

MeSH Terms

Interventions

Ephedrine; Norepinephrine

Intervention Hierarchy (Ancestors)

Propanolamines; Amino Alcohols; Alcohols; Organic Chemicals; Propanols; Amines; Phenethylamines; Ethylamines; Ethanolamines; Biogenic Monoamines; Biogenic Amines; Catecholamines; Catechols; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons

Central Study Contacts

Asma Ben Souissi, assistant professor

CONTACT

0021698336883; bsouissiasma@gmail.com

Mhamed Sami Mebazaa, Professor

CONTACT

0021622252589; msmebazaa@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of the anesthesia intensive care department

Model Details: controlled, prospective, randomised trial comparing 2 interventions

Study Record Dates

• First Submitted: October 19, 2018
• First Posted: October 25, 2018
• Study Start: January 2, 2019
• Primary Completion: May 30, 2019
• Study Completion: May 30, 2019
• Last Updated: December 3, 2018

Record last verified: 2018-10