NCT02477501

Brief Summary

The purpose of the study is to determine if norepinephrine is more effective as a continuous intravenous (IV) infusion compared to continuous IV ephedrine associated with crystalloid loading for maintaining blood pressure during a spinal anesthetic for a cesarean delivery. Prevention of low blood pressure has been shown to decrease nausea and vomiting during and after cesarean delivery under spinal anesthesia. For elective cesarean delivery, all participants will receive spinal anesthesia with a local anesthetic and morphine. This study plans to enroll 120 pregnant women. Patients will be randomly assigned according to a computer generated system to be in one of two groups.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
120

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Jan 2016

Shorter than P25 for phase_4

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

June 10, 2015

Completed
12 days until next milestone

First Posted

Study publicly available on registry

June 22, 2015

Completed
6 months until next milestone

Study Start

First participant enrolled

January 1, 2016

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2016

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2016

Completed
Last Updated

October 26, 2017

Status Verified

October 1, 2017

Enrollment Period

10 months

First QC Date

June 10, 2015

Last Update Submit

October 25, 2017

Conditions

Anesthesia; Adverse Effect, Spinal and EpiduralHypotensionComplications; Cesarean Section

Keywords

Spinal anesthesiacesareanblood pressureNorepinephrineEphedrine

Outcome Measures

Primary Outcomes (1)

  • Maternal Blood Pressure

    Measurement of systolic, diastolic and mean, non-invasive blood pressure during cesarean section with an infusion of either Ephedrine or Norepinephrine

    At time of surgery (right after spinal anesthesia untill end of surgery)

Secondary Outcomes (5)

  • Hemodynamic Parameters - heart rate

    At time of surgery (right after spinal anesthesia untill end of surgery)

  • Hemodynamic Parameters - arrhythmia

    AT TIME OF SURGERY(right after spinal anesthesia untill end of surgery)

  • Vomiting

    AT TIME OF SURGERY (right after spinal anesthesia untill end of surgery)

  • mean pH of the fetal cord blood in each group

    At time of birth

  • Nausea

    AT TIME OF SURGERY (right after spinal anesthesia untill end of surgery)

Study Arms (2)

Ephedrine

ACTIVE COMPARATOR

A continuous Ephedrine infusion at 10 mcg/kg/min

Drug: Ephedrine

Norepinephrine

ACTIVE COMPARATOR

A continuous Norepinephrine infusion at 0.1 mcg/kg/min

Drug: Norepinephrine

Interventions

NorepinephrineDRUG

continuous infusion

Also known as: Noradrenaline, Noraline
Norepinephrine
EphedrineDRUG

continuous infusion

Ephedrine

Eligibility Criteria

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

You may qualify if:

  • The American Society of Anesthesiologists (ASA) Physical Status classification 1 and 2
  • Pregnant women with singleton pregnancy
  • Gestational age greater than 36 weeks
  • Cesarean delivery under spinal anesthesia

You may not qualify if:

  • Use of cardiac medication or medication for blood pressure control
  • Cardiovascular disease
  • Multiple gestation
  • Gestation diabetes requiring insulin
  • Refusal to be in study
  • History of chronic opioid use (chronic pain syndrome)
  • Emergent caesarean delivery for maternal and/or fetal distress
  • Preeclampsia
  • Eclampsia
  • Progressive neurologic disease
  • Infection at insertion site
  • Allergy to local anesthetics, narcotics or other study medications

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Tunis maternity and neonatology center, minisetry of public health

Tunis, 1007, Tunisia

Location

MeSH Terms

Conditions

Hypotension

Interventions

NorepinephrineEphedrine

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

EthanolaminesAmino AlcoholsAlcoholsOrganic ChemicalsAminesBiogenic MonoaminesBiogenic AminesCatecholaminesCatecholsPhenolsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsPropanolaminesPropanolsPhenethylaminesEthylamines

Study Officials

  • Hayen maghrebi, professor

    University Tunis El Manar

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD, assistant professor

Study Record Dates

First Submitted

June 10, 2015

First Posted

June 22, 2015

Study Start

January 1, 2016

Primary Completion

November 1, 2016

Study Completion

December 1, 2016

Last Updated

October 26, 2017

Record last verified: 2017-10

Locations

TU(1)