NCT05035498

Brief Summary

The purpose of this study is to investigate the maternal cardiac output response to prophylactic norepinephrine and phenylephrine infusion for postspinal anesthesia hypotension in parturients with preeclampsia undergoing cesarean section.

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
72

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Feb 2024

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

September 2, 2021

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 5, 2021

Completed
2.4 years until next milestone

Study Start

First participant enrolled

February 1, 2024

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 21, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 21, 2025

Completed
Last Updated

February 2, 2024

Status Verified

January 1, 2024

Enrollment Period

1.2 years

First QC Date

September 2, 2021

Last Update Submit

January 31, 2024

Conditions

Hemodynamic Instability

Keywords

NorepinephrinePhenylephrineHemodynamic effectsPreeclampsiaCesarean section

Outcome Measures

Primary Outcomes (3)

  • Cardiac output (CO)

    Evaluated by the VIGILCO monitoring system

    1-30 minutes after spinal anesthesia

  • Stroke volume (SV)

    Evaluated by the VIGILCO monitoring system

    1-30 minutes after spinal anesthesia

  • Systemic vascular resistance (SVR)

    Evaluated by the VIGILCO monitoring system

    1-30 minutes after spinal anesthesia

Secondary Outcomes (12)

  • Overall stability of systolic blood pressure control versus baseline

    1-30 minutes after spinal anesthesia

  • Overall stability of heart rate control versus baseline

    1-30 minutes after spinal anesthesia

  • The incidence of post-spinal anesthesia hypotension

    1-30 minutes after spinal anesthesia.

  • The incidence of severe post-spinal anesthesia hypotension.

    1-30 minutes after spinal anesthesia.

  • The incidence of hypertension.

    1-30 minutes after spinal anesthesia

  • +7 more secondary outcomes

Study Arms (2)

Phenylephrine group

ACTIVE COMPARATOR

Phenylephrine infusion simultaneous with spinal anesthesia

Drug: Phenylephrine

Norepinephrine group

EXPERIMENTAL

Norepinephrine infusion simultaneous with spinal anesthesia

Drug: Norepinephrine

Interventions

PhenylephrineDRUG

A maintenance dose of phenylephrine (0.625 μg/kg/min) infusion simultaneous with subarachnoid block

Also known as: Vasopressors
Phenylephrine group
NorepinephrineDRUG

A maintenance dose of norepinephrine (0.05 μg/kg/min) infusion simultaneous with subarachnoid block

Also known as: Vasopressors
Norepinephrine group

Eligibility Criteria

Age18 Years - 45 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • years
  • Primipara or multipara
  • Singleton pregnancy ≥32 weeks
  • American Society of Anesthesiologists physical status classification II to III
  • Scheduled for cesarean section under spinal anesthesia

You may not qualify if:

  • Baseline blood pressure ≥180 mmHg
  • Body height \< 150 cm
  • Body weight \> 100 kg or body mass index (BMI) ≥ 40 kg/m2
  • Eclampsia or chronic hypertension
  • Hemoglobin \< 7g/dl
  • Fetal distress, or known fetal developmental anomaly

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

General Hospital of Ningxia Medical University

Yinchuan, Ningxia, 750004, China

RECRUITING

MeSH Terms

Conditions

Pre-Eclampsia

Interventions

PhenylephrineVasoconstrictor AgentsNorepinephrine

Condition Hierarchy (Ancestors)

Hypertension, Pregnancy-InducedPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital Diseases

Intervention Hierarchy (Ancestors)

EthanolaminesAmino AlcoholsAlcoholsOrganic ChemicalsAminesCardiovascular AgentsTherapeutic UsesPharmacologic ActionsChemical Actions and UsesBiogenic MonoaminesBiogenic AminesCatecholaminesCatecholsPhenolsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbons

Study Officials

  • Xinli Ni, Dr.

    General Hospital of Ningxia Medical University

    STUDY CHAIR

Central Study Contacts

Xinli Ni, Dr.

CONTACT

86-951-674-3252xinlini6@nyfy.com.cn

Yi Chen, M.D.

CONTACT

86-951-674-3252czzyxgp@163.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, CARE PROVIDER
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 2, 2021

First Posted

September 5, 2021

Study Start

February 1, 2024

Primary Completion

April 21, 2025

Study Completion

April 21, 2025

Last Updated

February 2, 2024

Record last verified: 2024-01

Locations

CN(1)