Norepinephrine Versus Ephedrine in Treatment of Hypotension During Spinal Anesthesia for Caesarean Section

NCT03163407 | Completed

• 1 other identifier: Mongi Slim Hospital
• Study Type: interventional
• Target: 110
• Locations: 0 countries
• Sites: N/A

Brief Summary

Prospective, randomized study, including full term parturients scheduled for caesarean section under spinal anesthesia. Spinal anesthesia was performed in sitting position with a 25 G spinal needle and all patients received 15 ml/kg of crystalloid intravenously during the spinal block. Baseline hemodynamics: heart rate, systolic and diastolic blood pressure were recorded before spinal anesthesia and intraoperatively. Postspinal hypotension, defined as decrease of Systolic blood pressure\>20% from the baseline value, was managed using Ephedrine increments 6 mg/3min in patients of GE group or by 5 mcg Norepinephrine/3min for the patients of GN group. Intraoperative hemodynamic data of the 2 groups were compared.

Conditions

Hypotension; Vasopressors; Cesarean Section Complications; Anesthesia Complication

Outcome Measures

Primary Outcomes (1)

• number of injections

  number of injections required to manage the post spinal hypotension

  number of injections required in the first hour

Study Arms (2)

Norepinephrine group

ACTIVE COMPARATOR

Treatment of the postspinal anesthesia hypotension by administrating 5 mcg of Norepinephrine intravenously every 3 min until normal systolic blood pressure

Drug: Norepinephrine

Ephedrine group

ACTIVE COMPARATOR

Management of the post spinal hypotension by administrating 6 mg of Ephedrine intravenously every 3 min

Drug: Ephedrine

Interventions

Norepinephrine DRUG

Treatment of the postspinal anesthesia hypotension by administrating 5 mcg of Norepinephrine intravenously every 3 min until normal systolic blood pressure

Norepinephrine group

Ephedrine DRUG

Management of the post spinal hypotension by administrating 6 mg of Ephedrine intravenously every 3 min

Ephedrine group

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Fully term parturients
• Caesarean section under spinal anesthesia
• ASA status I or II

You may not qualify if:

• Severe cardiac disease
• Cardiac arrhythmia

Sponsors & Collaborators

• Mongi Slim Hospital: lead

MeSH Terms

Conditions

Hypotension

Interventions

Norepinephrine; Ephedrine

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, head of the anesthesia and ICU departement

Study Record Dates

• First Submitted: May 19, 2017
• First Posted: May 23, 2017
• Study Start: July 1, 2016
• Primary Completion: December 31, 2016
• Study Completion: January 31, 2017
• Last Updated: May 23, 2017

Record last verified: 2017-05

Data Sharing

• IPD Sharing: Will not share