NCT06508359

Brief Summary

This study aims to explore the effects of different application modes (prophylactic and rescue strategy) of norepinephrine and norepinephrine on neonate umbilical artery pH undergoing cesarean section.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
700

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Aug 2025

Shorter than P25 for not_applicable

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

July 14, 2024

Completed
4 days until next milestone

First Posted

Study publicly available on registry

July 18, 2024

Completed
1 year until next milestone

Study Start

First participant enrolled

August 1, 2025

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 21, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 21, 2026

Completed
Last Updated

April 28, 2026

Status Verified

April 1, 2026

Enrollment Period

9 months

First QC Date

July 14, 2024

Last Update Submit

April 27, 2026

Conditions

Outcome

Keywords

Spinal anesthesia-induced hypotensionNorepinephrinePhenylephrineNeonatal outcomesCesarean section

Outcome Measures

Primary Outcomes (2)

  • pH

    From umbilical arterial blood gases.

    Immediately after delivery

  • Base excess (BE)

    From umbilical arterial blood gases.

    Immediately after delivery

Secondary Outcomes (8)

  • 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

  • +3 more secondary outcomes

Study Arms (4)

Prophylactic norepinephrine group

EXPERIMENTAL

A maintenance dose of norepinephrine (0.05 ug/kg/min) infusion simultaneous with spinal anesthesia. The maternal systolic blood pressure was consistently maintained above 80% of the preoperative baseline value from the initiation of spinal anesthesia until fetal delivery.

Drug: Norepinephrine

Prophylactic phenylephrine group

EXPERIMENTAL

A maintenance dose of phenylephrine (0.625 ug/kg/min) infusion simultaneous with spinal anesthesia. The maternal systolic blood pressure was consistently maintained above 80% of the preoperative baseline value from the initiation of spinal anesthesia until fetal delivery.

Drug: Phenylephrine

Rescue norepinephrine group

ACTIVE COMPARATOR

The maternal systolic blood pressure was consistently maintained above 80% of the preoperative baseline value from the initiation of spinal anesthesia until fetal delivery. Spinal anesthesia-induced hypotension is managed by administering a 6 μg intravenous bolus of norepinephrine.

Drug: Norepinephrine

Rescue phenylephrine group

ACTIVE COMPARATOR

The maternal systolic blood pressure was consistently maintained above 80% of the preoperative baseline value from the initiation of spinal anesthesia until fetal delivery. Spinal anesthesia-induced hypotension is managed by administering a 75 μg intravenous bolus of phenylephrine.

Drug: Phenylephrine

Interventions

NorepinephrineDRUG

Prophylactic or rescue norepinephrine for spinal anesthesia-induced hypotension

Also known as: Vasopressor
Prophylactic norepinephrine groupRescue norepinephrine group
PhenylephrineDRUG

Prophylactic or rescue phenylephrine for spinal anesthesia-induced hypotension

Also known as: Vasopressor
Prophylactic phenylephrine groupRescue phenylephrine group

Eligibility Criteria

Age18 Years - 45 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • years
  • Primipara or multipara
  • Singleton pregnancy ≥37 weeks
  • American Society of Anesthesiologists physical status classification II
  • Scheduled for cesarean section under spinal anesthesia

You may not qualify if:

  • Body height \< 150 cm
  • Body weight \> 100 kg or body mass index (BMI) ≥ 40 kg/m2
  • Eclampsia or chronic hypertension or baseline blood pressure ≥140 mmHg
  • 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

Interventions

NorepinephrineVasoconstrictor AgentsPhenylephrine

Intervention Hierarchy (Ancestors)

EthanolaminesAmino 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
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 14, 2024

First Posted

July 18, 2024

Study Start

August 1, 2025

Primary Completion

April 21, 2026

Study Completion

April 21, 2026

Last Updated

April 28, 2026

Record last verified: 2026-04

Locations

CN(1)