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Postoperative hypertension: a multicenter, prospective, randomized comparison between intravenous nicardipine and sodium nitroprusside

OBJECTIVE: To compare the efficacy and safety of iv nicardipine with sodium nitroprusside in the treatment of postoperative hypertension after both cardiac and noncardiac surgery. DESIGN: Multicenter, prospective, randomized, open-label study. SETTING: Six tertiary referral medical centers (recovery rooms and surgical ICUs). PATIENTS: A total of 139 patients with postoperative hypertension: i.v. nicardipine (n = 71), sodium nitroprusside (n = 68). INTERVENTION: Administration of i.v. nicardipine or sodium nitroprusside. MEASUREMENTS: Vital signs (BP, heart rate), hemodynamic variables, medication dosage, total number of dose changes, and time to achieve BP control were recorded. MAIN RESULTS: Both medications were equally effective in reducing BP in both the cardiac and noncardiac surgical groups. Under the conditions of the study, i.v. nicardipine controlled hypertension more rapidly than sodium nitroprusside (i.v. nicardipine 14.0 +/- 1.0 mins and sodium nitroprusside 30.4 +/- 3.5 mins, p = .0029). The total number of dose changes required to achieve therapeutic BP response was significantly less in the i.v. nicardipine-treated patients (i.v. nicardipine 1.5 +/- 0.2 vs. sodium nitroprusside 5.1 +/- 1.4, p < .05). Adverse effects were observed with both drugs (i.v. nicardipine 7% [5/71] and sodium nitroprusside 18% [12/68] [NS]). CONCLUSIONS: Intravenous nicardipine is as effective as sodium nitroprusside in the therapy of postoperative hypertension. Specific advantages have been identified. The use of i.v. nicardipine should be considered in the therapy of postoperative hypertension.

Trial
Journal Ref. Halpern NA, Goldberg M, Neely C, Sladen RN, Goldberg JS, Floyd J, et al: Postoperative hypertension: a multicenter, prospective, randomized comparison between intravenous nicardipine and sodium nitroprusside. Crit Care Med 1992, 20:1637-1643.
Intervention Drug - administration of iv nicardipine or sodium nitroprusside
Number of sites 6
Countries involved 1
Sample size 139
Type of statistical analyses ANOVA - analysis of variance BP changes, Kaplan Meier therapeutic doses.
Risk of bias Overall: High Risk details
Participant characteristics Age: 55-75
Condition: post-op hypertension
Baseline severity: 151±2 systolic; 81±2 diastolic
Duration of trial June 1988 to July 1989
Primary outcome Composite: BP/Heart Rate; Therapeutic response rate
Effect Measures
Events Intervention Total Events Control Total Risk Diff.
9 18 10 15 -16.67 %
Cardiac surgery [n=51] Nicardipine: Therapeutic response 14.0±1.0[SEM] mins [n=51] Nitropruss: Therapeutic response 30.4±3.5 min ( p=0.0029)
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.
2 3 4 4 2 -1 3 2 2