NCT05035472

Brief Summary

The purpose of this study is to investigate the potency between prophylactic norepinephrine and phenylephrine boluses for postspinal anesthesia hypotension in patients with severe preeclampsia during caesarean 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
80

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2023

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
1.3 years until next milestone

Study Start

First participant enrolled

January 1, 2023

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2023

Completed
Last Updated

September 13, 2021

Status Verified

September 1, 2021

Enrollment Period

12 months

First QC Date

September 2, 2021

Last Update Submit

September 5, 2021

Conditions

Adverse Effect

Keywords

NorepinephrinePhenylephrinePostspinal anesthesia hypotensionPreeclampsiaCesarean section

Outcome Measures

Primary Outcomes (1)

  • The dose that would be effective in preventing postspinal anesthesia hypotension in 50% (effective dose, ED 50) and 90% (ED90) of patients

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

    1-15 minutes after spinal anesthesia

Secondary Outcomes (10)

  • The incidence of post-spinal anesthesia hypotension

    1-15 minutes after spinal anesthesia

  • The incidence of severe post-spinal anesthesia hypotension.

    1-15 minutes after spinal anesthesia

  • The incidence of bradycardia.

    1-15 minutes after spinal anesthesia

  • The incidence of nausea and vomiting.

    1-15 minutes after spinal anesthesia

  • The incidence of hypertension.

    1-15 minutes after spinal anesthesia

  • +5 more secondary outcomes

Study Arms (2)

Phenylephrine group

ACTIVE COMPARATOR

Prophylactic phenylephrine bolus simultaneous with spinal anesthesia

Drug: Phenylephrine

Norepinephrine group

EXPERIMENTAL

Prophylactic norepinephrine bolus simultaneous with spinal anesthesia

Drug: Norepinephrine

Interventions

PhenylephrineDRUG

An initial prophylactic bolus dose of phenylephrine (37.5μg) simultaneous with spinal anesthesia. If the patient did not respond adequately to the current dose (SBP decreased to \< 80% of baseline), the dose was considered to have failed and the subsequent dose for the following patient was increased to the next higher dose level. The dose administered to subsequent patients varied by increments or decrements of 12.5 μg according to the responses of previous patients according to the up-down sequential allocation.

Also known as: Vasopressors
Phenylephrine group
NorepinephrineDRUG

An initial prophylactic bolus dose of norepinephrine (3μg) simultaneous with spinal anesthesia. The dose administered to subsequent patients varied by increments or decrements of 1 μg according to the responses of previous patients according to the up-down sequential allocation.

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

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

January 1, 2023

Primary Completion

December 31, 2023

Study Completion

December 31, 2023

Last Updated

September 13, 2021

Record last verified: 2021-09