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

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

Study Description

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.

Study Design

• 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

Arms and Interventions

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

Outcome Measures

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

Eligibility Criteria

• 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

Contacts and Locations

No Contacts or Locations Provided

More Information

• 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
• 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:

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