Hypotension Clinical Trial
Official title:
ED50 Determination of Hydroxyethylstarch for Treatment of Hypotension During Cesarean Section Under Spinal Anesthesia
The purpose of this trial is to determine the effective volume of hydroxyethylstarch 130/0.4 which would prevent the occurence of maternal hypotension in 50% of healthy pregnant women undergoing a cesarean section under spinal anesthesia.
The incidence of spinal anesthesia-induced hypotension in pregnant women undergoing a
cesarean section is high. A preoperative fluid bolus of undetermined volume is frequently
administered to lower the incidence of maternal hypotension, with a somewhat poor efficacy.
Recently, several investigations have shown that the use of a phenylephrine infusion after
the induction of spinal anesthesia results in a significant reduction in hypotensive
episodes. Given the high efficacy of this therapy (incidence of hypotension around 20%), it
is possible to determine the effective volume of fluid which would prevent hypotension in
50% of the patients studied (ED50).
Healthy term pregnant women undergoing elective cesarean section under spinal anesthesia
will be recruited in this trial. The spinal anesthesia regimen will be standardized and all
subjects will receive a phenylephrine infusion. The fluid investigated is hydroxyethylstarch
(HES) 130/0.4 (Volulyte(R)). The ED50 will be determined using an up-down sequential
allocation method initially described by Dixon & Massey. The determination of the HES ED50
will help the anesthesiologist in further treating maternal hypotension appropriately.
;
Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
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