Phenylephrine Versus Ephedrine in Pre-eclampsia

Duke University

Status and phase: Terminated; Phase 4

Conditions: Pre-eclampsia

Treatments: Drug: Ephedrine; Drug: Phenylephrine

Study type: Interventional

Funder types: Other

Identifiers

NCT02025426

Pro00032812

Details and patient eligibility

About

Phenylephrine administration is associated with reductions in CO and SctO2 compared with ephedrine when used for blood pressure management in women with pre-eclampsia undergoing cesarean delivery under spinal anesthesia.

Enrollment: 13 patients

Sex: Female

Ages: 18 to 50 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• English speaking
• Age ≥18 yrs
• Pre-eclampsia (mild, or severe)
• Non-laboring women
• CD under spinal anesthesia

Exclusion criteria

• Height < 5'0"
• Allergy to phenylephrine or ephedrine, or any other standardized medication
• Severe Cardiac disease in pregnancy with marked functional limitations (NYHA Class III and IV)
• Patients on Monoamine Oxidase Inhibitors or Tricyclic Antidepressants
• History of recent amphetamine or cocaine use.
• Subject enrollment in another study involving a study medication within 30 days of CD
• Any other physical or psychiatric condition which may impair their ability to cooperate with study data collection

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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13 participants in 2 patient groups

Phenylephrine

Active Comparator group

Description:

Phenylephrine for maintaining blood pressure within 10 % of baseline

Treatment:

Drug: Phenylephrine

Ephedrine

Active Comparator group

Description:

Ephedrine for maintaining blood pressure within 10 % of baseline

Treatment:

Drug: Ephedrine