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

Hypotension Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03163407
• Other study ID #: Mongi Slim Hospital
• Status: Completed
• Phase: N/A
• First received: May 19, 2017
• Last updated: May 19, 2017
• Start date: July 1, 2016
• Est. completion date: January 31, 2017

Study information

• Verified date: May 2017
• Source: Mongi Slim Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 110
• Est. completion date: January 31, 2017
• Est. primary completion date: December 31, 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Fully term parturients

• Caesarean section under spinal anesthesia

• ASA status I or II

Exclusion Criteria:

• Severe cardiac disease

• Cardiac arrhythmia

Related Conditions & MeSH terms

• Anesthesia Complication
• Cesarean Section Complications
• Hypotension
• Vasopressors

Intervention

Drug:
• Norepinephrine
Treatment of the postspinal anesthesia hypotension by administrating 5 mcg of Norepinephrine intravenously every 3 min until normal systolic blood pressure
• Ephedrine
Management of the post spinal hypotension by administrating 6 mg of Ephedrine intravenously every 3 min

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Mongi Slim Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	number of injections	number of injections required to manage the post spinal hypotension	number of injections required in the first hour