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

Study Overview
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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.

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.

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

Conditions
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Hypotension, Vasopressors, Cesarean Section Complications, Anesthesia Complication

Intervention / Treatment
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* Drug: Norepinephrine
* Drug: Ephedrine


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Fully term parturients Caesarean section under spinal anesthesia ASA status I or II Exclusion Criteria: Severe cardiac disease Cardiac arrhythmia

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Norepinephrine group<br>Treatment of the postspinal anesthesia hypotension by administrating 5 mcg of Norepinephrine intravenously every 3 min until normal systolic blood pressure | Drug: Norepinephrine<br>* Treatment of the postspinal anesthesia hypotension by administrating 5 mcg of Norepinephrine intravenously every 3 min until normal systolic blood pressure<br>|
| Active Comparator: Ephedrine group<br>Management of the post spinal hypotension by administrating 6 mg of Ephedrine intravenously every 3 min | Drug: Ephedrine<br>* Management of the post spinal hypotension by administrating 6 mg of Ephedrine intravenously every 3 min<br>|

What is the study measuring?
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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 |