At a glance
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Determination of the 90% Effective Dose of the Initial Bolus of Norepinephrine in Elective Cesarean Section: An Up-Down Study
In Brief
A Phase 4 clinical trial evaluating Norepinephrine for Hypotension and 4 related conditions. Completed, enrolled 60 participants across 1 site.
Detailed Summary
The investigators are aiming to determine what is the effective intravenous dose required of an initial bolus of norepinephrine prior to a maintenance infusion to prevent a 20% decrease in maternal blood pressure from baseline following the administration of spinal anesthesia for elective cesarean section in healthy parturients
Study Details
Timeline
Interventions
The outcome of patient n in each sequence will determine the dose to be allocated patient n+1. Successive doses will be determined with the up-and-down k-in-row design method for ED90 determination: * Failure: the dose should be increased in one level (+0.02 µg/kg) after failure to respond (arterial hypotension); * Success: decrease in one level (-0.02 µg/kg) upon successful response (no arterial hypotension), but only after observing at least k-consecutive positive responses at the same dose (in this case, k=7); otherwise, remain at the same dose. This will be done until each sequence completes n=30.