Pregnancy Hypotension
Conditions
Interventions
The minimum sample size will be 50 patients. The study will be composed of a group, pregnant women undergoing spinal anesthesia for cesarean section, who received phenylephrine vasopressor
In the operating room, every patient will be monitored with pulse oximetry, continuous electrocardioscopy and non-invasive blood pressure throughout the anesthetic-surgical procedure. The average of t
E04.520.252.500.150
Sponsors
Hospital Geral de Cuiabá – Associação de Proteção à Maternidade e à Infância de Cuiabá
Hospital Geral de Cuiabá – Associação de Proteção à Maternidade e à Infância de Cuiabá
Eligibility
Sex/Gender
Female
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: Healthy pregnant women; older than 18 years; undergoing elective cesarean section under spinal anesthesia who signed a Free and Informed Consent Form
Exclusion criteria
Exclusion criteria: Age less than 18 years; gestational age less than 37 weeks; systemic arterial hypertension and hypertensive disease of pregnancy, defined as a systolic blood pressure greater than 140 mmHg or diastolic blood pressure less than 90 mmHg; twinning; intrauterine growth retardation; New York Heart Association class II major cardiovascular disease; cerebrovascular disease, fetal abnormality and contraindications to spinal anesthesia
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. To avaluate the incidence of maternal hypotension. The method used to verify this outcome will be by measuring blood pressure with an automatic sphygmomanometer every 2 minutes, from the beginning of anesthesia until the birth of the fetus. Arterial hypotension will be defined as a drop in systolic blood pressure greater than 80% or less than 100 mmHg of preoperative blood pressure. A 40% reduction in the incidence of hypotension during cesarean section is expected to be found with the prophylactic intravenous use of phenylephrine. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1.To evaluate the consumption of phenylephrine in milligrams used to treat maternal hypotension. One of the researchers record the amount of phenylephrine used each time the criterion used to define hypotension is met. Expect to find a reduction in phenylephrine consumption in milligrams by 60 to 80%.;2. To avaluate the incidence of bradycardia with the use of prophylactic phenylephrine. The method used to demonstrate the occurrence of maternal bradycardia will be with the use of perioperative electrocardioscopy. Bradycardia will be defined as a heart rate less than 50 beats per minute. And it will be treated with the administration of 0.5 mg of atropine. It is expected to find a 10% increase in the incidence of bradycardia. ;3. To assess the number of times you stopped the phenylephrine infusion due to reactive hypertension by measuring blood pressure with an automatic sphygmomanometer for 2 minutes. Reactive hypertension will be defined as an increase in systolic blood pressure greater than 20% of baseline pressure. And it will be treated by stopping the prophylactic phenylephrine infusion. A low incidence of this outcome (less than 3%) is expected.;4. To assess the occurrence of nausea and vomiting. One of the researchers will record the occurrence of each event. Nausea will be defined as a bad and uncomfortable feeling in the upper abdomen and vomiting as forced elimination of gastric contents. A low incidence of this outcome of around 10% is expected.;5. To avaluate the pH, partial pressure of oxygen, partial pressure of carbon dioxide and base excess by means of arterial blood gas analysis of the newborn's umbilical cord. These parameters are expected to be normal in more than 95% of newborns. ;6. To avaluate the newborn's Apgar score at the first and fifth minutes. It will be evaluated by the clinical observation of the pediatrician present in the operating room. More than 99% of newborns are expected to obtain a score greater than 8 on a 0 to 10 Apgar scal | — |
Countries
Brazil
Contacts
Public ContactBreno Benevides Andrade
Hospital Geral de Cuiabá – Associação de Proteção à Maternidade e à Infância de Cuiabá
Outcome results
None listed