NCT05035485

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

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

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Sep 2022

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

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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
1 year until next milestone

Study Start

First participant enrolled

September 13, 2022

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 21, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 21, 2024

Completed
Last Updated

February 2, 2024

Status Verified

January 1, 2024

Enrollment Period

1.4 years

First QC Date

September 2, 2021

Last Update Submit

January 31, 2024

Conditions

Hemodynamic Instability

Keywords

Cardiac output responseNorepinephrinePhenylephrinePreeclampsiaCesarean 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 nausea and vomiting.

    1-30 minutes after spinal anesthesia

  • +7 more secondary outcomes

Study Arms (2)

Phenylephrine group

ACTIVE COMPARATOR

Rescue phenylephrine (75μg) was given when postspinal anesthesia hypotension occurred

Drug: Phenylephrine

Norepinephrine group

EXPERIMENTAL

Rescue norepinephrine (6μg) was given when postspinal anesthesia hypotension occurred

Drug: Norepinephrine

Interventions

PhenylephrineDRUG

A rescue phenylephrine (75μg) was given when postspinal anesthesia hypotension occurred within 30 minutes after spinal anesthesia

Also known as: Vasopressors
Phenylephrine group
NorepinephrineDRUG

A rescue norepinephrine (6μg) was given when postspinal anesthesia hypotension occurred within 30 minutes after spinal anesthesia

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, China

Location

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

  • Yi Chen, M.D.

    General Hospital of Ningxia Medical University

    STUDY CHAIR

  • Xiangzhao Xu, M.D.; Ph. D

    The People's Hospital of Nanchuan

    STUDY CHAIR

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

September 13, 2022

Primary Completion

January 21, 2024

Study Completion

January 21, 2024

Last Updated

February 2, 2024

Record last verified: 2024-01

Locations

CN(1)