Maternal and Neonatal Outcomes of the Use of Vasopressors to Treat Hypotension During Spinal Anesthesia for Cesarean
Status:
Withdrawn
Trial end date:
2014-07-01
Target enrollment:
Participant gender:
Summary
Anesthesia for cesarean section has been a great challenge for the anesthesiologist, for
mother and fetus are closely related. So the challenge is to anesthetize the mother without
interfering with the physiology of the fetus. The spinal block, although safe, are not free
of complications if not treated properly, may be responsible for increased fetal morbidity.
Among the major side effects, there is hypotension, with potentially serious consequences for
the maternal-fetal dyad. Hypotension in pregnant women at low risk may not lead to major
damage, but a pregnant woman with low reserves, as is the case of pregnant women with
pre-eclampsia, any drop in blood pressure of the mother can bring harm to the welfare of
mother and fetus. Based on the above, the purpose of this study is to compare the effects of
maternal and perinatal treatment of hypotension with ephedrine or metaraminol in pregnant
women with severe preeclampsia undergoing cesarean section under spinal anesthesia. There
will be a randomized, double-blind, which will be included pregnant women with severe
preeclampsia with indication of cesarean section, gestational age above 34 weeks gestation
and only.Will be Excluded women with hemorrhagic syndromes of pregnancy, HELLP syndrome,
eclampsia, cardiovascular or cerebrovascular disease, fetal distress and absolute
contraindications to spinal anesthesia.
All patients are fully informed of the research objectives and will only be included in the
study if they agree to participate and sign the Instrument of Consent. The project was
designed following the recommendations of Resolution 196/96 of the National Health and the
Declaration of Helsinki for research involving human subjects (2000). In addition, the
project was submitted to the Ethics Committee in Research of the Institute of Integrative
Medicine Professor Fernando Figueira, is approved. The study will be conducted from June 2011
to July 2012. The study variables are: consumption of metaraminol and ephedrine before and
after birth, the occurrence of nausea and vomiting, incidence of maternal hypotension, the
occurrence of reactive hypertension, occurrence of bradycardia, pH of umbilical cord, Apgar
score 5 minutes, need for face mask ventilation and ICU admission.
Phase:
Phase 3
Details
Lead Sponsor:
Instituto Materno Infantil Prof. Fernando Figueira