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

Sponsor

Mongi Slim Hospital (Other)

Overall Status

Completed

CT.gov ID

NCT03163407

Collaborator

(none)

110

Enrollment

Arms

Actual Duration (Months)

Study Details

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	N/A

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

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 :

Jul 1, 2016

Actual Primary Completion Date :

Dec 31, 2016

Actual Study Completion Date :

Jan 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

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

number of injections [number of injections required in the first hour]
number of injections required to manage the post spinal hypotension

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

Mongi Slim Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

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 1, 2017

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Additional relevant MeSH terms:

Hypotension

Norepinephrine

Ephedrine

Study Results

No Results Posted as of May 23, 2017