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

Not Applicable

Completed

• Conditions: Cesarean Section Complications; Hypotension; Anesthesia Complication; Vasopressors
• Interventions: Drug: Ephedrine; Drug: Norepinephrine

• Registration Number: NCT03163407
• Lead Sponsor: Mongi Slim Hospital

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.

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 Timeline

• Study Start: 2016-07-01
• Primary Completion: 2016-12-31
• Study Completion: 2017-01-31
• Status Verified: 2017-05
• Study First Submitted: 2017-05-19
• Study First Submitted QC: 2017-05-19
• Last Update Submitted: 2017-05-19
• Study First Posted: 2017-05-23
• Last Update Posted: 2017-05-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 110

Inclusion Criteria

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

Exclusion Criteria

• Severe cardiac disease
• Cardiac arrhythmia

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Ephedrine group	Ephedrine	Management of the post spinal hypotension by administrating 6 mg of Ephedrine intravenously every 3 min
Norepinephrine group	Norepinephrine	Treatment of the postspinal anesthesia hypotension by administrating 5 mcg of Norepinephrine intravenously every 3 min until normal systolic blood pressure

Primary Outcome Measures

Name	Time	Method
number of injections	number of injections required in the first hour	number of injections required to manage the post spinal hypotension