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

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ClinicalTrials.gov Identifier: NCT03163407
Recruitment Status : Completed
First Posted : May 23, 2017
Last Update Posted : May 23, 2017
Sponsor:
Information provided by (Responsible Party):
Mhamed Sami Mebazaa, 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.

Condition or disease Intervention/treatment Phase
Hypotension Vasopressors Cesarean Section Complications Anesthesia Complication Drug: Norepinephrine Drug: Ephedrine Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 110 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Supportive Care
Official Title: Norepinephrine Versus Ephedrine for Treatment of Hypotension During Spinal Anesthesia for Caesarean Section
Actual Study Start Date : July 1, 2016
Actual Primary Completion Date : December 31, 2016
Actual Study Completion Date : January 31, 2017


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




Primary Outcome Measures :
  1. number of injections [ Time Frame: number of injections required in the first hour ]
    number of injections required to manage the post spinal hypotension



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • Severe cardiac disease
  • Cardiac arrhythmia
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Responsible Party: Mhamed Sami Mebazaa, Professor, head of the anesthesia and ICU departement, Mongi Slim Hospital
ClinicalTrials.gov Identifier: NCT03163407    
Other Study ID Numbers: Mongi Slim Hospital
First Posted: May 23, 2017    Key Record Dates
Last Update Posted: May 23, 2017
Last Verified: May 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
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Hypotension
Vascular Diseases
Cardiovascular Diseases
Norepinephrine
Ephedrine
Adrenergic alpha-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Sympathomimetics
Autonomic Agents
Peripheral Nervous System Agents
Vasoconstrictor Agents
Central Nervous System Stimulants