Comparison Between Three Norepinephrine Bolus Doses for Management of Post-spinal Hypotension During Ceaserian Section for Patients With Preeclampsia

August 16, 2022 updated by: Mohamed Sayed Arafa, Kasr El Aini Hospital

Comparison Between Different Norepinephrine Bolus Doses for Management of Post-spinal Hypotension During Ceaserian Section for Patients With Preeclampsia

Maternal hypotension after subarachnoid block is a frequent and deleterious complication during lower segment caesarean section (LSCS). Prophylaxis against hypotension using vasopressors had become a standard recommendation. In mothers with preeclampsia, post-spinal hypotension is less frequent compared to healthy mothers; thus, the latest guidelines do not recommend using vasopressors in preeclampsia patients unless there is a hypotensive episode . The incidence of post-spinal hypotension in mother with preeclampsia is nearly 25%. The commonly used vasopressors during CS are ephedrine, phenylephrine, and recently norepinephrine. The use of ephedrine is usually accompanied with maternal tachycardia and foetal acidosis. Phenylephrine (PE) had been the first line for prevention and management of maternal hypotension; however, its use in mothers with preeclampsia had not been adequately investigated. Thus, the best vasopressor for management of hypotension in mothers with preeclampsia is unknown. Norepinephrine (NE) is an alpha adrenergic agonist with weak beta adrenergic agonistic activity; thus, it does not cause significant cardiac depression as phenylephrine does. NE was introduced for use during CS with promising results when used as infusion and as boluses in healthy mothers .

The use of NE boluses in management of hypotension in preeclamptic mothers was not adequately investigated. A dose 4 mcg NE was recently evaluated in preeclamptic mothers. In this study, we will compare 3 NE bolus doses (3 mcg, 4 mcg, and 5 mcg) in management of maternal hypotension after spinal block during CS in preeclamptic mothers.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

60

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
      • Cairo, Egypt
        • Cairo university, Kasr Alainy hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 40 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • pregnant female with preeclampsia
  • age 18-40

Exclusion Criteria:

  • age less than 18
  • age above 40
  • patient refusal of spinal anesthesia
  • patient with eclampsia
  • patient allergy to anesthesia drugs or to NE

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: 3 mcg grup
this group will receive Norepinephrine bolus of 3 mcg for management of hypotension.
Drug: Norepinephrine
mothers will received NE bolus of 3,4 or 5 mcg for management of hypotension according to group allocation
Other Names:
  • levophed
Active Comparator: 4 mcg group
this group will receive Norepinephrine bolus of 4 mcg for management of hypotension
Drug: Norepinephrine
mothers will received NE bolus of 3,4 or 5 mcg for management of hypotension according to group allocation
Other Names:
  • levophed
Active Comparator: 5 mcg group
this group will receive Norepinephrine bolus of 5 mcg for management of hypotension
Drug: Norepinephrine
mothers will received NE bolus of 3,4 or 5 mcg for management of hypotension according to group allocation
Other Names:
  • levophed

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Neonatal concentration of HCO3 from a sample of umbilical cord as a surrogate of neonatal outcome
Time Frame: up to 5 minutes after delivery
measuring HCO3 from umbilical cord blood gases analysis
up to 5 minutes after delivery

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Rate of successful management of maternal hypotension
Time Frame: 2 minutes after NE bolus
defined as returned of SBP to be > 80% of the baseline reading in the next reading 2 minutes after administration of NE bolus
2 minutes after NE bolus

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Kasr El Aini Hospital

Investigators

  • Principal Investigator: Mohamed S Arafa, MD, Lecturer of anesthesia and surgical ICU

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 15, 2022

Primary Completion (Actual)

August 1, 2022

Study Completion (Actual)

August 15, 2022

Study Registration Dates

First Submitted

May 6, 2022

First Submitted That Met QC Criteria

May 9, 2022

First Posted (Actual)

May 10, 2022

Study Record Updates

Last Update Posted (Actual)

August 18, 2022

Last Update Submitted That Met QC Criteria

August 16, 2022

Last Verified

August 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Levo bolus in CS

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

upon reasonable request

IPD Sharing Time Frame

August 2022

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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