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

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

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.

Study Overview

• Status: Completed
• Conditions: Cesarean Section Complications; Hypotension; Anesthesia Complication; Vasopressors
• Intervention / Treatment: Drug: Norepinephrine; Drug: Ephedrine

Detailed Description

Prospective, randomized study including full term parturients scheduled for caesarean section under spinal anesthesia. All patients were ASA status I/II and patients with arrhythmia were excluded. Spinal anesthesia was performed in sitting position at L3-4 or L4-5. A 25 G spinal needle was used for intrathecal injection of 8 mg of hyperbaric bupivacaine, 2.5 mcg sufentanil and 100 mcg morphine. All patients received 15 ml/kg of crystalloids intravenously during the spinal block. Patients were positioned in left lateral tilt position. Baseline hemodynamics; HR, systolic (SBP) and diastolic blood pressure (DPB) were recorded before spinal anesthesia and intraoperatively (every 2 min). Post anesthesia hypotension was defined as decrease of SBP>20% from the baseline value. If hypotension occurred, patients were randomized into 2 groups:

• GE group in which hypotension were managed using ephedrine increments of 6 mg Ephedrine every 3 min until correction of SBP
• GN group: patients of this group received 5mcg of Norepinephrine/3 min demographic and hemodynamic data of the two groups were compared.

• Study Type: Interventional
• Enrollment (Actual): 110
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

Description

Inclusion Criteria:

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

Exclusion Criteria:

• Severe cardiac disease
• Cardiac arrhythmia

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: Norepinephrine group; Treatment of the postspinal anesthesia hypotension by administrating 5 mcg of Norepinephrine intravenously every 3 min until normal systolic blood pressure	Drug: Norepinephrine; Treatment of the postspinal anesthesia hypotension by administrating 5 mcg of Norepinephrine intravenously every 3 min until normal systolic blood pressure
ACTIVE_COMPARATOR: Ephedrine group; Management of the post spinal hypotension by administrating 6 mg of Ephedrine intravenously every 3 min	Drug: Ephedrine; Management of the post spinal hypotension by administrating 6 mg of Ephedrine intravenously every 3 min

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
number of injections	number of injections required to manage the post spinal hypotension	number of injections required in the first hour

Collaborators and Investigators

• Sponsor: Mongi Slim Hospital

Study record dates

Study Major Dates

• Study Start (ACTUAL): July 1, 2016
• Primary Completion (ACTUAL): December 31, 2016
• Study Completion (ACTUAL): January 31, 2017

Study Registration Dates

• First Submitted: May 19, 2017
• First Submitted That Met QC Criteria: May 19, 2017
• First Posted (ACTUAL): May 23, 2017

Study Record Updates

• Last Update Posted (ACTUAL): May 23, 2017
• Last Update Submitted That Met QC Criteria: May 19, 2017
• Last Verified: May 1, 2017

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: Mongi Slim Hospital

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO