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
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Condition or disease | Intervention/treatment | Phase |
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Hypotension Vasopressors Cesarean Section Complications Anesthesia Complication | Drug: Norepinephrine Drug: Ephedrine | Not Applicable |
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 (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 |
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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
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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
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Drug: Ephedrine
Management of the post spinal hypotension by administrating 6 mg of Ephedrine intravenously every 3 min |
- 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 |
Inclusion Criteria:
- Fully term parturients
- Caesarean section under spinal anesthesia
- ASA status I or II
Exclusion Criteria:
- Severe cardiac disease
- Cardiac arrhythmia
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 |
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 |