NCT04556370

Brief Summary

The purpose of this study is to investigate the suitable infusion dose 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
180

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Nov 2021

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
1.2 years until next milestone

Study Start

First participant enrolled

November 16, 2021

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 6, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 6, 2023

Completed
Last Updated

June 13, 2023

Status Verified

June 1, 2023

Enrollment Period

1.6 years

First QC Date

September 15, 2020

Last Update Submit

June 9, 2023

Conditions

Adverse Effect

Keywords

NorepinephrinePostspinal anesthesia hypotensionPreeclampsiaCesarean sectionDose-finding

Outcome Measures

Primary Outcomes (1)

  • The incidence of post-spinal anesthesia hypotension

    Systolic blood pressure (SBP) \< 80% of the baseline

    1-15 minutes after spinal anesthesia.

Secondary Outcomes (11)

  • Overall stability of systolic blood pressure control versus baseline

    1-15 minutes after spinal anesthesia

  • Overall stability of heart rate control versus baseline

    1-15 minutes after spinal anesthesia

  • The incidence of severe post-spinal anesthesia hypotension

    1-15 minutes after spinal anesthesia

  • The incidence of nausea and vomiting

    1-15 minutes after spinal anesthesia

  • The incidence of bradycardia

    1-15 minutes after spinal anesthesia

  • +6 more secondary outcomes

Study Arms (4)

Control group

PLACEBO COMPARATOR

Normal saline infusion simultaneous with subarachnoid block

Drug: Normal saline

0.025 μg/kg/min group

EXPERIMENTAL

A maintenance dose of norepinephrine (0.025 μg/kg/min) infusion simultaneous with subarachnoid block

Drug: Norepinephrine

0.050 μg/kg/min group

EXPERIMENTAL

A maintenance dose of norepinephrine (0.050 μg/kg/min) infusion simultaneous with subarachnoid block

Drug: Norepinephrine

0.075 μg/kg/min group

EXPERIMENTAL

A maintenance dose of norepinephrine (0.075 μg/kg/min) infusion simultaneous with subarachnoid block

Drug: Norepinephrine

Interventions

Normal salineDRUG

Normal saline infusion simultaneous with subarachnoid block

Also known as: NS
Control group
NorepinephrineDRUG

Different infusion dose of norepinephrine simultaneous with subarachnoid block

Also known as: Vasopressors
0.025 μg/kg/min group0.050 μg/kg/min group0.075 μg/kg/min 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, 75004, China

Location

Related Publications (1)

  • Chen Y, Guo L, Qin R, Xi N, Wang S, Ma Y, Ni X. Dose-Response Study of Norepinephrine Infusion for Maternal Hypotension in Preeclamptic Patients Undergoing Cesarean Delivery Under Spinal Anesthesia. Clin Pharmacokinet. 2024 Jun;63(6):847-856. doi: 10.1007/s40262-024-01381-4. Epub 2024 Jun 13.

    PMID: 38869701DERIVED

MeSH Terms

Conditions

Pre-Eclampsia

Interventions

Saline SolutionNorepinephrineVasoconstrictor Agents

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Crystalloid SolutionsIsotonic SolutionsSolutionsPharmaceutical PreparationsEthanolaminesAmino AlcoholsAlcoholsOrganic ChemicalsAminesBiogenic MonoaminesBiogenic AminesCatecholaminesCatecholsPhenolsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsCardiovascular AgentsTherapeutic UsesPharmacologic ActionsChemical Actions and Uses

Study Officials

  • Yi Chen, M.D.

    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

November 16, 2021

Primary Completion

June 6, 2023

Study Completion

June 6, 2023

Last Updated

June 13, 2023

Record last verified: 2023-06

Locations

CN(1)