NCT04576663

Brief Summary

The purpose of this study is to investigate the suitable infusion dose of phenylephrine for prophylaxis against postspinal anesthesia hypotension in parturients with preeclampsia undergoing cesarean section.

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
95

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Oct 2023

Typical duration for not_applicable

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 30, 2020

Completed
6 days until next milestone

First Posted

Study publicly available on registry

October 6, 2020

Completed
3 years until next milestone

Study Start

First participant enrolled

October 1, 2023

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 21, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 21, 2025

Completed
Last Updated

November 29, 2021

Status Verified

September 1, 2021

Enrollment Period

2 years

First QC Date

September 30, 2020

Last Update Submit

November 25, 2021

Conditions

Adverse Effect

Keywords

PhenylephrinePostspinal 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

0.3125 μg/kg/min group

EXPERIMENTAL

A maintenance dose of phenylephrine (0.3125 μg/kg/ min) infusion simultaneous with subarachnoid block

Drug: Phenylephrine

0.625 μg/kg/min group

EXPERIMENTAL

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

Drug: Phenylephrine

0.9375 μg/kg/min group

EXPERIMENTAL

A maintenance dose of phenylephrine (0.9375 μg/kg/ min) infusion simultaneous with subarachnoid block

Drug: Phenylephrine

Interventions

Normal salineDRUG

Normal saline infusion simultaneous with subarachnoid block

Also known as: NS
Control group
PhenylephrineDRUG

Different infusion dose of phenylephrine simultaneous with subarachnoid block

Also known as: Vasopressors
0.3125 μg/kg/min group0.625 μg/kg/min group0.9375 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

MeSH Terms

Conditions

Pre-Eclampsia

Interventions

Saline SolutionPhenylephrineVasoconstrictor Agents

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Crystalloid SolutionsIsotonic SolutionsSolutionsPharmaceutical PreparationsEthanolaminesAmino AlcoholsAlcoholsOrganic ChemicalsAminesCardiovascular AgentsTherapeutic UsesPharmacologic ActionsChemical Actions and Uses

Study Officials

  • Xinli Ni, Dr.

    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
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 30, 2020

First Posted

October 6, 2020

Study Start

October 1, 2023

Primary Completion

September 21, 2025

Study Completion

September 21, 2025

Last Updated

November 29, 2021

Record last verified: 2021-09