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Nicardipine versus nitroprusside for breakthrough hypertension following carotid endarterectomy

STUDY OBJECTIVE: To evaluate the effectiveness of nicardipine and nitroprusside for breakthrough hypertension following carotid endarterectomy. DESIGN: Prospective, randomized, double-blind, controlled effectiveness trial. SETTING: University-based surgical intensive care unit. PATIENTS: 60 ASA physical status I, II, III, and IV patients experiencing breakthrough hypertension at the time of admission to the intensive care unit (ICU). INTERVENTIONS: Patients received either nicardipine (n = 29) and placebo or nitroprusside (n = 31) and placebo for up to 6 hours postoperatively. Loading doses of nicardipine were provided, but placebo was used as a load for patients 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 control (p < 0.01). Following initial control, 12 nicardipine- and 24 nitroprusside-treated patients required additional titration of their infusions to maintain blood pressure within the targeted range (p < 0.05). No patient suffered a stroke, myocardial infarction, or was returned to the operating room (OR) for bleeding. CONCLUSIONS: Nicardipine administration produced more rapid BP control, most likely related to the administration of a loading dose. In addition to more rapid control, nicardipine-treated patients had less variability in BP and required significantly fewer additional interventions. Although no patient suffered a major event during this study, this study was not powered sufficiently to assess safety.

Trial
Journal Ref. Dorman T, Thompson DA, Breslow MJ, Lipsett PA, Rosenfeld BA: Nicardipine versus nitroprusside for breakthrough hypertension following carotid endarterectomy. Journal of Clinical Anesthesia 2001, 13:16-19.
Intervention Drug - administration of nicardipine or nitroprusside
Number of sites 1
Countries involved 1
Sample size 60
Type of statistical analyses Unclear appears to be ITT post-randomisation
Risk of bias Overall: Low Risk details
Participant characteristics Age: 70±10 nicardopine/ 67.3±10 Nitroprusside
Condition: Hypertension following carotid endartectomy
Baseline severity: preoperative BP eg Nitropusside MBP 106±12/ Nicardipine MBP 101±15
Duration of trial 10-month 1995-1996
Primary outcome Rapidity and variability of blood pressure control
Effect Measures
Events Intervention Total Events Control Total Risk Diff.
83 100 23 100 60.00 %
Nicardipine: Therapeutic response approx. 15min Nitropruss: Therapeutic response approx. 60mins (more variation)
Show Score Ranges

Scores:

(shows median if more than one score was entered)

Elig. Recr. Setting Org. Int. Flex. Del. Flex. Adherence Follow-Up Prim. Out. Prim. An.
3 3 1 5 5 -1 5 4 5