Pregnancy
Conditions
Interventions
This is a randomized, controlled, double-blind, non-inferiority clinical trial. It will consist of 140 obese pregnant women with a single fetus with gestational age >
36 weeks who are candidates for elective cesarean section, classified in Physical Status II to III of the American Society of Anesthesiologists and who sign the Informed Consent Form. Patients with pr
Sponsors
Associação de Proteção a Maternidade e a Infancia de Cuiabá
Hospital Geral e Maternidade de Cuiabá
Eligibility
Sex/Gender
Female
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: Pregnant women with a single fetus; gestational age greater than 36 weeks; age greater than or equal to 18 years; body mass índex (BMI) 35kg/m2; candidates for elective cesarean section under spinal anesthesia; classified as Physical Status II to III by the American Society of Anesthesiologists (ASA); who sign the Informed Consent Form
Exclusion criteria
Exclusion criteria: Hypertensive disease of pregnancy; pre-existing arterial hypertension (blood pressure greather than 140/90); twin pregnancy; known cerebrovascular or cardiovascular disease; suspected or confirmed congenital malformation or fetal distress; active labor; emergency cesarean section; any contraindication to spinal anesthesia; refusal to participate in the study; and spinal anesthesia failure
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To evaluate the incidence of maternal hypotension. This will be verified by measuring blood pressure with an automatic sphygmomanometer every 2 minutes, from the beginning of anesthesia until the end of surgery. An incidence of hypotension of 27% is expected for phenylephrine and norepinephrine infusion (respecting the non-inferiority margin of 20%) | — |
Secondary
| Measure | Time frame |
|---|---|
| To evaluate the number of hypotensive episodes. This will be verified by measuring blood pressure with an automatic sphygmomanometer every 2 minutes, from the beginning of anesthesia until the end of surgery. The median number of maternal hypotensive episodes is expected to be zero for both phenylephrine and norepinephrine infusion;To evaluate the incidence of reactive hypertension. This will be verified by measuring blood pressure with an automatic sphygmomanometer every 2 minutes, from the beginning of anesthesia until the end of surgery. The incidence of reactive hypertension is expected to be less than 10% in both study groups;To evaluate the incidence of bradycardia with the prophylactic use of phenylephrine. This was verified by the method of perioperative electrocardiography. Bradycardia was defined as a heart rate below 55 beats per minute (bpm). A 20% reduction in the incidence of bradycardia is expected with norepinephrine infusion compared to phenylephrine infusion;"To evaluate the incidence of nausea and vomiting. Verified by the method of direct observation and recording by one of the researchers. A low incidence of this outcome is expected, around 10%, in both study groups;To evaluate pH, partial pressure of oxygen, partial pressure of carbon dioxide, base excess, and lactate, verified by the method of umbilical cord arterial blood gas analysis of the newborn. These parameters are expected to be similar in both study groups;To evaluate the Apgar score of the newborn at the first and fifth minutes. Verified by the method of clinical observation by the pediatrician present in the obstetric operating room. It is expected that more than 95% of newborns will achieve a score greater than 7 in both study groups | — |
Countries
Brazil
Contacts
Public ContactMatheus Fiorotti
Hospital Geral e Maternidade de Cuiabá
Outcome results
None listed