Study Objective: To evaluate the effectiveness of nicardipine and nitroprus
side for breakthrough hypertension following carotid endarterectomy,
Design: Prospective, randomized, double-blind controlled effectiveness tria
l.
Setting: University-based surgical intensive care unit.
Patients: GO ASA physical status I; II, III, and IV patients experiencing b
reakthrough hypertension at the time of admission to the intensive care uni
t (ICU).
Interventions: Patients received either nicardipine (n = 29) and placebo or
nitroprusside (n = 31) and placebo for up to 6 hours postoperatively, Load
ing doses of nicardipine were provided, but placebo was wed as a load for p
atients randomized to nitroprusside.
Measurements and Main Results: Rapidity and variability of blood pressure (
BP) control were assessed. During the first 10 minutes, 83% of nicardipine
patients compared to 23% of nitroprusside-treated patients, achieved BP con
trol (p < 0.01). Following initial control, 12 nicardipine- and 24 nitropru
sside-treated patients required additional titration of their infusions to
maintain blood pressure within the targeted range (p < 0.05). No patient su
ffered a stroke, myocardial infarction, or was returned to the operating ro
om (OR) for bleeding.
Conclusions: Nicardipine administration produced more rapid BP control, mos
t likely related to the administration of a loading dose. In addition to mo
re rapid control, nicardipine-treated patients had less variability in BP a
nd required significantly fewer additional interventions. Although no patie
nt suffered a major event during this study, this study was not powered suf
ficiently to assess safety. (C) 2001 by Elsevier Science Inc.