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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Preeclampsia

Intervention / Treatment
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* Drug: Ephedrine
* Drug: Phenylephrine
* Drug: Metaraminol


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Preeclampsia patients After 34 weeks pregnant Exclusion Criteria: Patients' refusal Obstetric Emergency Contraindications to spinal anesthesia Obesity

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Ephedrine Group<br>Patients who will receive ephedrine after spinal anesthesia | Drug: Ephedrine<br>* 5mg after Spinal Anesthesia<br>|
| Experimental: Phenylephrine Group<br>Patients who will receive Phenylephrine after spinal anesthesia | Drug: Phenylephrine<br>* 100mcg after Spinal Anesthesia<br>|
| Experimental: Metaraminol<br>Patients who will receive Metaraminol after spinal anesthesia | Drug: Metaraminol<br>* 200mcg Metaraminol after Spinal Anesthesia<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Vasopressor, Cesarian delivery, Hypotension, Maternal cardiac output, Uteroplacental blood flow, Cerebral fetal blood flow, Preeclampsia