NCT03672071

Brief Summary

The aim of this study is to investigate the effect of combined use of Ephedrine and Norepinephrine on maternal hemodynamics in patients undergoing cesarean delivery under spinal anesthesia. Secondary aim of the study is to investigate the effect of this combination on neonatal Apgar score and umbilical cord blood gas values.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
90

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Sep 2018

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 4, 2018

Completed
1 month until next milestone

First Posted

Study publicly available on registry

September 14, 2018

Completed
16 days until next milestone

Study Start

First participant enrolled

September 30, 2018

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 30, 2018

Completed
1 day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2018

Completed
Last Updated

September 14, 2018

Status Verified

August 1, 2018

Enrollment Period

2 months

First QC Date

August 4, 2018

Last Update Submit

September 11, 2018

Conditions

Cesarean

Keywords

ephedrinenorepinephrinematernal hemodynamicsspinal anesthesia

Outcome Measures

Primary Outcomes (2)

  • systolic arterial blood pressure

    The maximal aortic pressure following ejection is termed the systolic pressure.Throughout the surgical procedure, it will be recorded using noninvasive methods every 2 minute as mm/Hg

    during operation

  • diastolic arterial blood pressure

    The lowest pressure in the aorta, which occurs just before the ventricle ejects blood into the aorta, is termed the diastolic pressure.Throughout the surgical procedure, it will be recorded using noninvasive methods every 2 minute as mm/Hg

    during operation

Study Arms (3)

Group E

OTHER

If a 20% decrease in any parameter compared to their baseline levels is sustained, necessary interventions 5 mg Ephedrine i.v. will be administered to patient will be performed. In the case of hypotension,

Other: Ephedrine, Noradrenaline ,ephedrine+Noradrenaline)

Group NE

OTHER

.If a 20% decrease in any parameter compared to their baseline levels is sustained, necessary interventions 5 mg Noradrenaline, i.v. will be administered to patient will be performed. In the case of hypotension,

Other: Ephedrine, Noradrenaline ,ephedrine+Noradrenaline)

Group N

OTHER

. If a 20% decrease in parameter compared to their baseline levels is sustained, necessary interventions mg Ephedrine + 2.5 mg Noradrenaline i.v. will be administered to patient will be performed. In the case of hypotension,

Other: Ephedrine, Noradrenaline ,ephedrine+Noradrenaline)

Interventions

Ephedrine, Noradrenaline ,ephedrine+Noradrenaline)OTHER

If a 20% decrease in any hemodynamic parameter compared to their baseline levels is sustained, necessary interventions will be performed. In the case of hypotension, for all groups

Group EGroup NGroup NE

Eligibility Criteria

Age18 Years - 45 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsTerm pregnant patients
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Term pregnant patients.

You may not qualify if:

  • A maternal cardiac diseases
  • Pulmonary diseases
  • Placenta previa
  • Placental abruption
  • Intrauterine fetal death
  • Expectancy for a syndromic child
  • İntrauterine growth restriction
  • Preeclampsia

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Celaleddin Soyalp

Van, 65080, Turkey (Türkiye)

RECRUITING

MeSH Terms

Interventions

Ephedrine

Intervention Hierarchy (Ancestors)

PropanolaminesAmino AlcoholsAlcoholsOrganic ChemicalsPropanolsAminesPhenethylaminesEthylamines

Study Officials

  • CELALEDDİN SOYALP

    Yuzuncu Yil University Dursun Odabas Medical School Anesthesiology a nd Reanimation Department, Van, Turkey

    PRINCIPAL INVESTIGATOR

Central Study Contacts

CELALEDDİN SOYALP

CONTACT

5068456504c.soyalp@hotmail.com

YUZKAT NUREDDIN

CONTACT

+905052294728nyuzkat@gmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
OTHER
Intervention Model
PARALLEL
Model Details: A randomized prospective controlled study
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assist. prof.

Study Record Dates

First Submitted

August 4, 2018

First Posted

September 14, 2018

Study Start

September 30, 2018

Primary Completion

November 30, 2018

Study Completion

December 1, 2018

Last Updated

September 14, 2018

Record last verified: 2018-08

Locations

TU(1)