Norepinephrine Versus Ephedrine in Treatment of Hypotension During Spinal Anesthesia for Caesarean Section
Primary Purpose
Hypotension, Vasopressors, Cesarean Section Complications
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Norepinephrine
Ephedrine
Sponsored by
About this trial
This is an interventional supportive care trial for Hypotension
Eligibility Criteria
Inclusion Criteria:
- Fully term parturients
- Caesarean section under spinal anesthesia
- ASA status I or II
Exclusion Criteria:
- Severe cardiac disease
- Cardiac arrhythmia
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Norepinephrine group
Ephedrine group
Arm Description
Treatment of the postspinal anesthesia hypotension by administrating 5 mcg of Norepinephrine intravenously every 3 min until normal systolic blood pressure
Management of the post spinal hypotension by administrating 6 mg of Ephedrine intravenously every 3 min
Outcomes
Primary Outcome Measures
number of injections
number of injections required to manage the post spinal hypotension
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03163407
Brief Title
Norepinephrine Versus Ephedrine in Treatment of Hypotension During Spinal Anesthesia for Caesarean Section
Official Title
Norepinephrine Versus Ephedrine for Treatment of Hypotension During Spinal Anesthesia for Caesarean Section
Study Type
Interventional
2. Study Status
Record Verification Date
May 2017
Overall Recruitment Status
Completed
Study Start Date
July 1, 2016 (Actual)
Primary Completion Date
December 31, 2016 (Actual)
Study Completion Date
January 31, 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Mongi Slim Hospital
4. Oversight
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypotension, Vasopressors, Cesarean Section Complications, Anesthesia Complication
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
110 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Norepinephrine group
Arm Type
Active Comparator
Arm Description
Treatment of the postspinal anesthesia hypotension by administrating 5 mcg of Norepinephrine intravenously every 3 min until normal systolic blood pressure
Arm Title
Ephedrine group
Arm Type
Active Comparator
Arm Description
Management of the post spinal hypotension by administrating 6 mg of Ephedrine intravenously every 3 min
Intervention Type
Drug
Intervention Name(s)
Norepinephrine
Intervention Description
Treatment of the postspinal anesthesia hypotension by administrating 5 mcg of Norepinephrine intravenously every 3 min until normal systolic blood pressure
Intervention Type
Drug
Intervention Name(s)
Ephedrine
Intervention Description
Management of the post spinal hypotension by administrating 6 mg of Ephedrine intravenously every 3 min
Primary Outcome Measure Information:
Title
number of injections
Description
number of injections required to manage the post spinal hypotension
Time Frame
number of injections required in the first hour
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Fully term parturients
Caesarean section under spinal anesthesia
ASA status I or II
Exclusion Criteria:
Severe cardiac disease
Cardiac arrhythmia
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Norepinephrine Versus Ephedrine in Treatment of Hypotension During Spinal Anesthesia for Caesarean Section
We'll reach out to this number within 24 hrs