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

Preeclampsia Clinical Trial

Official title:

Ephedrine, Phenylephrine and Metaraminol Effects on Maternal Cardiac Output, Uterine Blood Flow and Fetal Circulation in Patients With Preeclampsia Under Spinal Anesthesia for Cesarean

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02245191
• Other study ID #: VASPRES-3
• Status: Active, not recruiting
• Phase: N/A
• First received: August 7, 2014
• Last updated: September 16, 2014
• Start date: July 2014

Study information

• Verified date: May 2014
• Source: University of Sao Paulo General Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brazil: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 60
• Est. primary completion date: July 2014
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Preeclampsia patients

• After 34 weeks pregnant

Exclusion Criteria:

• Patients' refusal

• Obstetric Emergency

• Contraindications to spinal anesthesia

• Obesity

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Pre-Eclampsia
• Preeclampsia

Intervention

Drug:
• Ephedrine
5mg after Spinal Anesthesia
• Phenylephrine
100mcg after Spinal Anesthesia
• Metaraminol
200mcg Metaraminol after Spinal Anesthesia

Locations

Country	Name	City	State
Brazil	University of São Paulo	São Paulo

Sponsors (1)

Lead Sponsor	Collaborator
University of Sao Paulo General Hospital

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Middle cerebral artery pulsatility index changes before and after spinal anesthesia and vasopressor use.	The main purpose of this study is evaluate if one of related drugs (ephedrine, phenylephrine or metaraminol) is superior than others to keep the maternal cardiac output, uteroplacental and fetal cerebral bloodflow despite the hemodynamic changes that is peculiar after spinal anesthesia.	One year	Yes
Primary	Maternal cardiac output changes after vasopressor (ephedrine, phenylephrine or metaraminol) use in pregnant patients under spinal anesthesia		One year	Yes
Primary	Uterine arterial pulsatility index changes before and after spinal anesthesia and vasopressor use.		One year	Yes
Primary	Umbilical arterial pulsatility index changes before an after spinal anesthesia and vasopressor use		One year	Yes