Ephedrine, Phenylephrine and Metaraminol Effects on Maternal Cardiac Output, Uterine Blood Flow and Fetal Circulation

NCT ID: NCT02245191

Last Updated: 2014-09-19

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-07-31

Brief Summary

It is a prospective clinical trial with random distribution that intends to investigate maternal and fetal effects of ephedrine, phenylephrine and metaraminol during cesarean delivery in patients with pre-eclampsia.

Detailed Description

Spinal anesthesia has become the main anesthetic technique for cesarean delivery due to avoidance of failed tracheal intubation risk, improvement of post-operative analgesia and promotion of early mother-neonate bonding. Spinal anesthesia should be safe and comfortable for mother and child when referring to the side effects, including hypotension. The choice of the best vasopressor in this context is approaching to a resolution, favoring phenylephrine use. However, studies on high-risk pregnancies are still required, such as uteroplacental insufficiency, preeclampsia and intra-uterine growth restriction cases. The purpose of this study is to compare the effects of the vasopressors ephedrine, phenylephrine and metaraminol on maternal cardiac output, uteroplacental and cerebral fetal blood flow in patients with preeclampsia under spinal anesthesia for cesarean delivery. Sixty pregnant patients will be recruited and randomly assigned to receive either ephedrine, phenylephrine or metaraminol, making a total of three groups with 20 patients each. Variables to be analyzed are uterine arterial pulsatility index, umbilical arterial pulsatility index, fetus middle cerebral artery pulsatility index, maternal cardiac output, maternal cardiac frequency, maternal mean arterial blood pressure and maternal peripheral vascular resistance. These variables will be recorded in three moments: before the spinal anesthesia with the patient in dorsal recumbent and left displacement of the uterus, after spinal anesthesia in dorsal recumbent and after vasopressor bolus. Averages will be calculated in these intervals and then compared to the alteration caused by spinal anesthesia and the return to basal levels after drug intervention.

Conditions

Preeclampsia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: DOUBLE

Study Groups

Ephedrine Group

Patients who will receive ephedrine after spinal anesthesia

Group Type: EXPERIMENTAL

Ephedrine

Intervention Type: DRUG

5mg after Spinal Anesthesia

Phenylephrine Group

Patients who will receive Phenylephrine after spinal anesthesia

Group Type: EXPERIMENTAL

Phenylephrine

Intervention Type: DRUG

100mcg after Spinal Anesthesia

Metaraminol

Patients who will receive Metaraminol after spinal anesthesia

Group Type: EXPERIMENTAL

Metaraminol

Intervention Type: DRUG

200mcg Metaraminol after Spinal Anesthesia

Interventions

Ephedrine

5mg after Spinal Anesthesia

Intervention Type: DRUG

Phenylephrine

100mcg after Spinal Anesthesia

Intervention Type: DRUG

Metaraminol

200mcg Metaraminol after Spinal Anesthesia

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Preeclampsia patients
• After 34 weeks pregnant

Exclusion Criteria

• Patients' refusal
• Obstetric Emergency
• Contraindications to spinal anesthesia
• Obesity

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

University of Sao Paulo General Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Fernando Bliacheriene, MD

Role: STUDY_DIRECTOR

Instituto do Coracao

Locations

University of São Paulo

São Paulo, São Paulo, Brazil

Countries

Brazil

Other Identifiers

VASPRES-3

Identifier Type: -

Identifier Source: org_study_id