NCT03997500

Brief Summary

The purpose of this study is to investigate the preventive effect of norepinephrine on post-spinal hypotension and the effect of norepinephrine on inferior vena cava collapsibility index (IVC-CI).

Trial Health

87
On Track

Trial Health Score

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

Enrollment
195

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2019

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

Study Start

First participant enrolled

January 1, 2019

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

May 28, 2019

Completed
28 days until next milestone

First Posted

Study publicly available on registry

June 25, 2019

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 21, 2019

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2019

Completed
Last Updated

February 17, 2020

Status Verified

May 1, 2019

Enrollment Period

10 months

First QC Date

May 28, 2019

Last Update Submit

February 13, 2020

Conditions

Adverse Effect

Keywords

NorepinephrineHypotensionInferior Vena Cava Collapsibility IndexCesarean Delivery

Outcome Measures

Primary Outcomes (2)

  • The incidence of hypotension

    SBP decreased to \<80% of the baseline value

    1 to 20 minutes after subarachnoid block

  • Inferior vena cava collapsibility index

    CI = (dIVCmax - dIVCmin)/dIVCmax

    5 to 20 minutes after subarachnoid block

Secondary Outcomes (10)

  • The incidence of nausea and vomiting

    1 to 20 minutes after subarachnoid block

  • The incidence of bradycardia

    1 to 20 minutes after subarachnoid block

  • Incidence of hypertension

    1 to 20 minutes after subarachnoid block

  • Arterial base excess of fetal vein blood

    Immediately after delivery

  • Pressure of oxygen of fetal vein blood

    Immediately after delivery

  • +5 more secondary outcomes

Study Arms (2)

Normal saline

PLACEBO COMPARATOR

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

Drug: normal saline

Norepinephrine

EXPERIMENTAL

Simultaneous with subarachnoid block, a bolus of norepinephrine was given followed by norepinephrine infusion

Drug: Norepinephrine

Interventions

normal salineDRUG

a bolus of normal saline was given followed by normal saline infusion

Also known as: NS
Normal saline
NorepinephrineDRUG

a bolus of norepinephrine was given followed by norepinephrine infusion

Also known as: Vasopressors
Norepinephrine

Eligibility Criteria

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

You may qualify if:

  • years
  • American Society of Anesthesiologists physical status classification I to II
  • Scheduled for elective cesarean delivery under spinal anesthesia
  • Full-term, singleton, pregnant women

You may not qualify if:

  • Height of no more than 150 centimeters
  • Body weight greater than 100 kg or BMI greater than 30
  • Labor analgesia had been performed
  • Contraindication of spinal or epidural anesthesia
  • Eclampsia or chronic hypertension or baseline blood pressure ≥160mmHg
  • Hemoglobin \<7g/dl
  • Fetal distress or known abnormal fetal development
  • Severe vascular disease
  • Diabetes mellitus or cardiovascular disease or nervous system disease

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

Saline SolutionNorepinephrineVasoconstrictor Agents

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

Crystalloid SolutionsIsotonic SolutionsSolutionsPharmaceutical PreparationsEthanolaminesAmino AlcoholsAlcoholsOrganic ChemicalsAminesBiogenic MonoaminesBiogenic AminesCatecholaminesCatecholsPhenolsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsCardiovascular AgentsTherapeutic UsesPharmacologic ActionsChemical Actions and Uses

Study Officials

  • Xinli Ni, Dr.

    xinlini6@yahoo.com

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 28, 2019

First Posted

June 25, 2019

Study Start

January 1, 2019

Primary Completion

October 21, 2019

Study Completion

December 31, 2019

Last Updated

February 17, 2020

Record last verified: 2019-05

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)