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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

110 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-07-01

Study Completion Date

2017-01-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Hypotension Vasopressors Cesarean Section Complications Anesthesia Complication

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

SINGLE

Participants

Study Groups

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Norepinephrine group

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

Group Type ACTIVE_COMPARATOR

Norepinephrine

Intervention Type DRUG

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

Ephedrine group

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

Group Type ACTIVE_COMPARATOR

Ephedrine

Intervention Type DRUG

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

Interventions

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Norepinephrine

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

Intervention Type DRUG