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

Sponsor

University of Sao Paulo General Hospital (Other)

Overall Status

Unknown status

CT.gov ID

NCT02245191

Collaborator

(none)

Enrollment

Location

Arms

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Preeclampsia	Drug: Ephedrine Drug: Phenylephrine Drug: Metaraminol	N/A

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

60 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Investigator)

Primary Purpose:

Diagnostic

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

Study Start Date :

Jul 1, 2014

Actual Primary Completion Date :

Jul 1, 2014

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Ephedrine Group Patients who will receive ephedrine after spinal anesthesia	Drug: Ephedrine 5mg after Spinal Anesthesia
Experimental: Phenylephrine Group Patients who will receive Phenylephrine after spinal anesthesia	Drug: Phenylephrine 100mcg after Spinal Anesthesia
Experimental: Metaraminol Patients who will receive Metaraminol after spinal anesthesia	Drug: Metaraminol 200mcg Metaraminol after Spinal Anesthesia

Arm

Intervention/Treatment

Experimental: Ephedrine Group

Patients who will receive ephedrine after spinal anesthesia

Drug: Ephedrine

5mg after Spinal Anesthesia

Experimental: Phenylephrine Group

Patients who will receive Phenylephrine after spinal anesthesia

Drug: Phenylephrine

100mcg after Spinal Anesthesia

Experimental: Metaraminol

Patients who will receive Metaraminol after spinal anesthesia

Drug: Metaraminol

200mcg Metaraminol after Spinal Anesthesia

Outcome Measures

Primary Outcome Measures

Middle cerebral artery pulsatility index changes before and after spinal anesthesia and vasopressor use. [One year]
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.
Maternal cardiac output changes after vasopressor (ephedrine, phenylephrine or metaraminol) use in pregnant patients under spinal anesthesia [One year]
Uterine arterial pulsatility index changes before and after spinal anesthesia and vasopressor use. [One year]
Umbilical arterial pulsatility index changes before an after spinal anesthesia and vasopressor use [One year]