NCT02101047

Brief Summary

Three different regimens of phenylephrine are being evaluated to see if one is superior over the other in the maintenance of cardiac output while keeping normotension and/or treating hypotension experienced when receiving spinal anesthesia for cesarean delivery.

Trial Health

30
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Timeline
Completed

Started Aug 2015

Geographic Reach
1 country

1 active site

Status
withdrawn

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

March 27, 2014

Completed
5 days until next milestone

First Posted

Study publicly available on registry

April 1, 2014

Completed
1.3 years until next milestone

Study Start

First participant enrolled

August 1, 2015

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2016

Completed
Last Updated

November 8, 2017

Status Verified

February 1, 2017

Enrollment Period

1.4 years

First QC Date

March 27, 2014

Last Update Submit

November 6, 2017

Conditions

Complications; Cesarean SectionSpinal Anesthetics Causing Adverse Effects in Therapeutic Use

Keywords

cesarean sectionhypotensionphenylephrine

Outcome Measures

Primary Outcomes (1)

  • Magnitude of cardiac output changes

    Magnitude of cardiac output reduction for the duration from preoperative baseline from time of spinal anesthesia to delivery of fetus and placenta.

    0-90 minutes

Secondary Outcomes (7)

  • provider intervention

    0-90 minutes

  • vasopressor requirement

    0-90 minutes

  • Emetic symptoms

    0-90 minutes

  • hypertension

    0-90 minutes

  • hypotension

    0-90 minutes

  • +2 more secondary outcomes

Study Arms (3)

phenylephrine 50mcg bolus

EXPERIMENTAL

Phenylephrine 50 mcg bolus dosing with continuous placebo infusion

Drug: Phenylephrine

Phenylephrine 100 mcg bolus

EXPERIMENTAL

Phenylephrine 100 mcg bolus dosing wtih continuous placebo infusion.

Drug: Phenylephrine

Phenylephrine continuous infusion 100mcg/min

EXPERIMENTAL

Continuous phenylephrine infusion of 100 mcg/min with placebo bolus dosing.

Drug: Phenylephrine

Interventions

PhenylephrineDRUG
Phenylephrine 100 mcg bolusPhenylephrine continuous infusion 100mcg/minphenylephrine 50mcg bolus

Eligibility Criteria

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

You may qualify if:

  • scheduled for cesarean delivery age \>/=18 years of age \>/= 37 weeks EGA ASA status I-III

You may not qualify if:

  • allergy to medications used in the study non-English speaking

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Novant Health Forsyth Medical Center

Winston-Salem, North Carolina, 27103, United States

Location

MeSH Terms

Conditions

Hypotension

Interventions

Phenylephrine

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

EthanolaminesAmino AlcoholsAlcoholsOrganic ChemicalsAmines

Study Officials

  • Peter Pan, MD

    Wake Forest University Health Sciences

    PRINCIPAL INVESTIGATOR
0

Study Design

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

Study Record Dates

First Submitted

March 27, 2014

First Posted

April 1, 2014

Study Start

August 1, 2015

Primary Completion

December 31, 2016

Study Completion

December 31, 2016

Last Updated

November 8, 2017

Record last verified: 2017-02

Locations

US(1)