NCT04272567

Brief Summary

The purpose of this study is to investigate the suitable infusion dose of norepinephrine for prophylaxis against post-spinal anesthesia hypotension.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
99

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Mar 2020

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

February 11, 2020

Completed
6 days until next milestone

First Posted

Study publicly available on registry

February 17, 2020

Completed
1 month until next milestone

Study Start

First participant enrolled

March 28, 2020

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2020

Completed
Last Updated

August 4, 2020

Status Verified

February 1, 2020

Enrollment Period

3 months

First QC Date

February 11, 2020

Last Update Submit

July 31, 2020

Conditions

Adverse Effect

Keywords

NorepinephrineHypotensionCesarean 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 (5)

Control group

SHAM COMPARATOR

Simultaneous with subarachnoid block, a bolus of 1ml normal saline was given followed by normal saline infusion

Drug: Normal saline

0.025 μg/kg/min group

EXPERIMENTAL

Simultaneous with subarachnoid block, a bolus of 6μg norepinephrine was given followed by a maintenance dose of norepinephrine (0.025 μg/kg/min).

Drug: Norepinephrine

0.05 μg/kg/min group

EXPERIMENTAL

Simultaneous with subarachnoid block, a bolus of 6μg norepinephrine was given followed by a maintenance dose of norepinephrine (0.05 μg/kg/min).

Drug: Norepinephrine

0.075 μg/kg/min group

EXPERIMENTAL

Simultaneous with subarachnoid block, a bolus of 6μg norepinephrine was given followed by a maintenance dose of norepinephrine (0.075 μg/kg/min).

Drug: Norepinephrine

0.1 μg/kg/min group

EXPERIMENTAL

Simultaneous with subarachnoid block, a bolus of 6μg norepinephrine was given followed by a maintenance dose of norepinephrine (0.1 μg/kg/min).

Drug: Norepinephrine

Interventions

NorepinephrineDRUG

Simultaneous with subarachnoid block, a bolus of 6μg norepinephrine was given followed by different infusion dose of norepinephrine.

Also known as: Vasopressors
0.025 μg/kg/min group0.05 μg/kg/min group0.075 μg/kg/min group0.1 μg/kg/min group
Normal salineDRUG

Simultaneous with subarachnoid block, a bolus of 1ml normal saline was given followed by normal saline infusion

Also known as: NS
Control group

Eligibility Criteria

Age18 Years - 40 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 I to II
  • Scheduled for elective 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 ≥ 160mmHg
  • 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

Conditions

Hypotension

Interventions

NorepinephrineVasoconstrictor AgentsSaline Solution

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

EthanolaminesAmino AlcoholsAlcoholsOrganic ChemicalsAminesBiogenic MonoaminesBiogenic AminesCatecholaminesCatecholsPhenolsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsCardiovascular AgentsTherapeutic UsesPharmacologic ActionsChemical Actions and UsesCrystalloid SolutionsIsotonic SolutionsSolutionsPharmaceutical Preparations

Study Officials

  • Xinli Ni, Dr.

    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
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 11, 2020

First Posted

February 17, 2020

Study Start

March 28, 2020

Primary Completion

June 30, 2020

Study Completion

June 30, 2020

Last Updated

August 4, 2020

Record last verified: 2020-02

Locations

CN(1)