Hypotension Clinical Trial
Official title:
Comparative Study of the Effect of 6% Hydroxyethyl Starch 130/0.42 vs Lactated Ringer's Preload on the Hemodynamic Status of Parturients Undergoing Spinal Anesthesia for Elective Cesarean Delivery. Arterial Pulse Contour Analysis (FloTrac/VigileoTM) is Employed for Continuous Monitoring of Maternal Hemodynamic Parameters
Regional anesthesia (spinal, epidural) is considered the method of choice for anesthesia
obstetric deliveries because of the ability to use fewer drugs, a more direct experience of
childbirth and the capability to provide excellent postoperative analgesia. However, the
incidence of hypotension after spinal anesthesia for cesarean delivery is high and can lead
to maternal and fetal morbidities. Certain interventions may reduce the incidence and
severity of spinal anesthesia induced hypotension, including the use of vasopressors and
intravenous pre- or co-hydration using different types of volume expanders; crystalloid or
colloid solutions. Such interventions aim to increase maternal cardiac output, which is the
key in attenuating the hypotensive response to spinal anesthesia.
The primary purpose of this study is to compare the efficacy of intravenous prehydration
(preloading) of healthy parturients scheduled for caesarean section with either a
crystalloid (Ringer's lactated) or colloid solution (HES 130/0.42) in the prevention of
hypotension after spinal anesthesia.
The FloTrac/VigileoTM device provides continuous monitoring of maternal cardiac output by
employment of a minimally invasive technique based on arterial pulse contour analysis.
Assessment of maternal hemodynamic status using the FloTrac/VigileoTM constitutes a
secondary outcome. Other secondary outcomes are total amount of vasopressors used, neonatal
outcome, intraoperative side effects and maternal satisfaction scores.
n/a
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment
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