Hypotension Clinical Trial
Official title:
Norepinephrine To Prevent Hypotension After Spinal Anesthesia For Cesarean Delivery: A Dose Finding Study
Spinal anesthesia is the most common anesthetic technique for elective Cesarean delivery
(CD), but the most frequent unwanted side effect is hypotension, which can cause nausea and
vomiting, as well as effects on the fetus. Prevention and treatment of maternal hypotension
includes intravenous fluids and vasopressors. Phenylephrine is the most common vasopressor
used for this purpose. However, it has been shown to reduce maternal heart rate and cardiac
output, which may be a concern in an already compromised fetus. Norepinephrine is commonly
used in high concentrations in intensive care and recent studies have suggested that in low
concentrations it may be a better alternative to phenylephrine in elective CD, as it does
not reduce the maternal heart rate or cardiac output. The optimum bolus dose of
norepinephrine to prevent hypotension after spinal anesthesia in elective CD has not been
elucidated. The investigators propose this study to determine the dose that would be
effective in 90% of patients (ED90).
A previous study by Ngan Kee et al, using continuous infusion of norepinephrine to prevent
hypotension in elective CD, suggested a potency ratio for norepinephrine to phenylephrine of
approximately 16:1. Hence, the investigators hypothesise that the ED90 will be approximately
6 µg, given that the current phenylephrine bolus dose at the investigators' institution is
approximately 100 µg.
The use of norepinephrine to prevent and treat hypotension during cesarean delivery (CD) is new and data in the literature are scarce. A recent randomised controlled trial by Ngan Kee et al compared continuous infusions of norepinephrine and phenylephrine to prevent hypotension during CD. They showed that norepinephrine was effective at maintaining blood pressure, with a greater cardiac output and heart rate compared to phenylephrine. However, the effective bolus dose of norepinephrine needed to prevent maternal hypotension was not determined, and since this is a relatively new arena, no dose-response studies are available in the literature either. Therefore, it would be logical to establish the effective bolus dose of norepinephrine TO PREVENT HYPOTENSION during elective CD. ;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment
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