NCT04556357

Brief Summary

The purpose of this study is to investigate the efficacy and safety of norepinephrine for prophylaxis against 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
138

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Sep 2020

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 15, 2020

Completed
6 days until next milestone

First Posted

Study publicly available on registry

September 21, 2020

Completed
1 day until next milestone

Study Start

First participant enrolled

September 22, 2020

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 15, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 15, 2021

Completed
Last Updated

November 29, 2021

Status Verified

September 1, 2020

Enrollment Period

1.1 years

First QC Date

September 15, 2020

Last Update Submit

November 25, 2021

Conditions

Adverse Effect

Keywords

NorepinephrinePostspinal anesthesia hypotensionPreeclampsiaCesarean section

Outcome Measures

Primary Outcomes (1)

  • The incidence of bradycardia

    Heart rate \< 60 beats/min

    1-15 minutes after spinal anesthesia.

Secondary Outcomes (1)

  • Overall stability of systolic blood pressure control versus baseline

    1-15 minutes after spinal anesthesia

Other Outcomes (10)

  • Overall stability of heart rate control versus baseline

    1-15 minutes after spinal anesthesia

  • The incidence of postspinal anesthesia hypotension

    1-15 minutes after spinal anesthesia

  • The incidence of severe post-spinal anesthesia hypotension

    1-15 minutes after spinal anesthesia

  • +7 more other outcomes

Study Arms (2)

Control group

ACTIVE COMPARATOR

Phenylephrine infusion simultaneous with subarachnoid block

Drug: Phenylephrine

Norepinephrine group

EXPERIMENTAL

Norepinephrine infusion simultaneous with subarachnoid block

Drug: Norepinephrine

Interventions

PhenylephrineDRUG

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

Also known as: Vasopressors
Control 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

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

  • Xinli Ni, Dr.

    General Hospital of Ningxia Medical University

    STUDY CHAIR

Study Design

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

Study Record Dates

First Submitted

September 15, 2020

First Posted

September 21, 2020

Study Start

September 22, 2020

Primary Completion

November 15, 2021

Study Completion

November 15, 2021

Last Updated

November 29, 2021

Record last verified: 2020-09

Locations

CN(1)