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

Sponsor
Kasr El Aini Hospital (Other)
Overall Status
Completed
CT.gov ID
NCT05368415
Collaborator
(none)
60
Enrollment
1
Location
3
Arms
3
Actual Duration (Months)
19.9
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase
Phase 4

Study Design

Study Type:
Interventional
Actual Enrollment :
60 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Care Provider, Investigator)
Primary Purpose:
Treatment
Official Title:
Comparison Between Different Norepinephrine Bolus Doses for Management of Post-spinal Hypotension During Ceaserian Section for Patients With Preeclampsia
Actual Study Start Date :
May 15, 2022
Actual Primary Completion Date :
Aug 1, 2022
Actual Study Completion Date :
Aug 15, 2022

Arms and Interventions

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

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Neonatal concentration of HCO3 from a sample of umbilical cord as a surrogate of neonatal outcome [up to 5 minutes after delivery]

      measuring HCO3 from umbilical cord blood gases analysis

    Secondary Outcome Measures

    1. Rate of successful management of maternal hypotension [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

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 40 Years
    Sexes Eligible for Study:
    Female
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Cairo university, Kasr Alainy hospital Cairo Egypt

    Sponsors and Collaborators

    • Kasr El Aini Hospital

    Investigators

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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    Mohamed Sayed Arafa, lecturer of anesthesia and surgical ICU, Kasr El Aini Hospital
    ClinicalTrials.gov Identifier:
    NCT05368415
    Other Study ID Numbers:
    • Levo bolus in CS
    First Posted:
    May 10, 2022
    Last Update Posted:
    Aug 18, 2022
    Last Verified:
    Aug 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    Yes
    Plan to Share IPD:
    Yes
    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
    Additional relevant MeSH terms:
    Pre-Eclampsia
    Hypotension
    Norepinephrine

    Study Results

    No Results Posted as of Aug 18, 2022