NCT06158022

Brief Summary

The objective of this study is to investigate the ED90 of norepinephrine and phenylephrine infusions for preventing postspinal anesthesia hypotension under intensive treatment in preeclamptic patients during cesarean section

Trial Health

87
On Track

Trial Health Score

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

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Oct 2024

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 25, 2023

Completed
11 days until next milestone

First Posted

Study publicly available on registry

December 6, 2023

Completed
10 months until next milestone

Study Start

First participant enrolled

October 3, 2024

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 20, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 20, 2025

Completed
Last Updated

October 6, 2025

Status Verified

September 1, 2025

Enrollment Period

8 months

First QC Date

November 25, 2023

Last Update Submit

September 30, 2025

Conditions

Adverse Effect

Outcome Measures

Primary Outcomes (1)

  • ED50 and ED90

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

    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)

Norepinephrine group

EXPERIMENTAL

The maternal systolic blood pressure was consistently maintained above 90% of the preoperative baseline value from the initiation of spinal anesthesia until fetal delivery.

Drug: Norepinephrine

Phenylephrine group

EXPERIMENTAL

The maternal systolic blood pressure was consistently maintained above 90% of the preoperative baseline value from the initiation of spinal anesthesia until fetal delivery.

Drug: Phenylephrine

Interventions

NorepinephrineDRUG

An initial infusion dose of prophylactic norepinephrine (0.05 ug/kg/min) simultaneous with spinal anesthesia. The dose administered to subsequent patients varied by increments or decrements of 0.01 ug/kg/min of prophylactic norepinephrine according to the responses of previous patients according to the up-down sequential allocation.

Also known as: Vasopressor
Norepinephrine group
PhenylephrineDRUG

An initial infusion dose of prophylactic phenylephrine (0.5 ug/kg/min) simultaneous with spinal anesthesia. The dose administered to subsequent patients varied by increments or decrements of 0.1 ug/kg/min of prophylactic phenylephrine according to the responses of previous patients according to the up-down sequential allocation.

Also known as: Vasopressor
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 ≥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 ≥160 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 University

Yinchuan, Ningxia, 750004, China

Location

Related Publications (1)

  • Ma Y, Ma R, Shi Y, Qin R, Chen Y. Determination of ED90s of Phenylephrine and Norepinephrine Infusion for Strict Blood Pressure Management Targets in Preeclamptic Patients Undergoing Cesarean Section: A Randomized Sequential Allocation Study. Drug Des Devel Ther. 2025 Nov 1;19:9751-9757. doi: 10.2147/DDDT.S545813. eCollection 2025.

    PMID: 41200476DERIVED

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, CARE PROVIDER
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 25, 2023

First Posted

December 6, 2023

Study Start

October 3, 2024

Primary Completion

May 20, 2025

Study Completion

May 20, 2025

Last Updated

October 6, 2025

Record last verified: 2025-09

Locations

CN(1)