Preeclampsia
Conditions
Keywords
Vasopressor, Cesarian delivery, Hypotension, Maternal cardiac output, Uteroplacental blood flow, Cerebral fetal blood flow, Preeclampsia
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.
Interventions
DRUGEphedrine
5mg after Spinal Anesthesia
DRUGPhenylephrine
100mcg after Spinal Anesthesia
DRUGMetaraminol
200mcg Metaraminol after Spinal Anesthesia
Sponsors
University of Sao Paulo General Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Preeclampsia patients * After 34 weeks pregnant
Exclusion criteria
* Patients' refusal * Obstetric Emergency * Contraindications to spinal anesthesia * Obesity
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 | — |
Countries
Brazil
Outcome results
None listed