NCT02854787

Brief Summary

The purpose of the study is to determine if an intravenous bolus of phenylephrine is more effective compared to an intravenous bolus of norepinephrine 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 sufentanil. 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 May 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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2016

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

July 30, 2016

Completed
4 days until next milestone

First Posted

Study publicly available on registry

August 3, 2016

Completed
29 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2016

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2016

Completed
Last Updated

October 26, 2017

Status Verified

July 1, 2016

Enrollment Period

4 months

First QC Date

July 30, 2016

Last Update Submit

October 25, 2017

Conditions

Anesthesia, Spinal and EpiduralAdverse EffectHypotensionComplications, Cesarean Section

Keywords

Spinal anesthesiacesareanblood pressureNorepinephrinePhenylephrine

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 until end of surgery)

Secondary Outcomes (5)

  • Hemodynamic Parameters - heart rate

    At time of surgery (right after spinal anesthesia until end of surgery

  • Hemodynamic Parameters - arrhythmia

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

  • Vomiting

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

Study Arms (2)

Phenylephrine

ACTIVE COMPARATOR

A bolus of 100 mcg

Drug: Phenylephrine

Norepinephrine

ACTIVE COMPARATOR

A bolus of 0,2 mcg/kg

Drug: Norepinephrine

Interventions

PhenylephrineDRUG

A bolus of 100 mcg

Phenylephrine
NorepinephrineDRUG

A bolus of 0,2 mcg/kg

Also known as: Noraline, Noradrénaline
Norepinephrine

Eligibility Criteria

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

You may qualify if:

  • of Anesthesiologists (ASA) Physical Status classification 1 and 2
  • Pregnant women with singleton pregnancy

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

PhenylephrineNorepinephrine

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

EthanolaminesAmino AlcoholsAlcoholsOrganic ChemicalsAminesBiogenic MonoaminesBiogenic AminesCatecholaminesCatecholsPhenolsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbons

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

July 30, 2016

First Posted

August 3, 2016

Study Start

May 1, 2016

Primary Completion

September 1, 2016

Study Completion

December 1, 2016

Last Updated

October 26, 2017

Record last verified: 2016-07

Locations

TU(1)