Articles: postoperative-complications.
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Randomized Controlled Trial Multicenter Study Clinical Trial
Efficacy and safety of intravenous nicardipine in the control of postoperative hypertension. IV Nicardipine Study Group.
In a double-blind, randomized, multicenter study, the efficacy and safety of intravenous (IV) nicardipine was compared with placebo in the control of postoperative hypertension in cardiac and noncardiac surgical patients. One hundred twenty-two patients (17 cardiac and 105 noncardiac surgery) met the entry criteria (systolic BP greater than or equal to 140 mm Hg or diastolic BP greater than or equal to 95 mm Hg) and were randomized (3:2) to receive IV nicardipine (n = 71) or placebo (n = 51). Therapeutic response (greater than or equal to 15 percent reduction in BP from baseline) was achieved in 94 percent of patients treated with IV nicardipine vs 12 percent with placebo (p less than 0.001). ⋯ In the placebo group, the incidence of adverse experience was 6 percent, with an equal distribution of hypotension (2 percent), nausea/vomiting (2 percent), and headache (2 percent). No clinically important changes in laboratory variables related to IV nicardipine were reported. In conclusion, these findings indicate that nicardipine, a titratable intravenous calcium channel blocker, can rapidly and effectively control postoperative hypertension in cardiac and noncardiac surgical patients.
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Randomized Controlled Trial Multicenter Study Clinical Trial
Prevention by ambroxol of bronchopulmonary complications after upper abdominal surgery: double-blind Italian multicenter clinical study versus placebo.
A double-blind multicenter study was carried out to evaluate the effectiveness of ambroxol, a drug able to promote surfactant synthesis, in the prevention of postoperative bronchopulmonary complications. A total of 252 patients with chronic obstructive lung disease (COLD) undergoing upper abdominal surgery were randomly allocated to receive either 1 g/day of ambroxol intravenously for 6 consecutive days in the perioperative period or placebo. Pulmonary complications were evaluated by clinical studies, radiographic, and blood gas analysis. ⋯ In addition, analysis of variance showed that the PaO2 values of the ambroxol-treated group after surgery decreased less than those of the placebo-treated group (p less than 0.05) from the preoperative values. The treatment was well tolerated, although nausea was significantly more frequent in the ambroxol-treated group. We think that ambroxol should be considered as an alternative and new pharmacologic approach for the prevention of postoperative pulmonary complications.
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Randomized Controlled Trial Multicenter Study Clinical Trial
Psychological outcomes of different treatment policies in women with early breast cancer outside a clinical trial.
To assess outside a clinical trial the psychological outcome of different treatment policies in women with early breast cancer who underwent either mastectomy or breast conservation surgery depending on the surgeon's opinion or the patient's choice. To determine whether the extent of psychiatric morbidity reported in women who underwent breast conservation surgery was associated with their participation in a randomised clinical trial. ⋯ There is still no evidence that women with early breast cancer who undergo breast conservation surgery have less psychiatric morbidity after treatment than those who undergo mastectomy. Women who surrender autonomy for decision making by agreeing to participate in randomised clinical trials do not experience any different psychological, sexual, or social problems from those women who are treated for breast cancer outside a clinical trial.
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Randomized Controlled Trial Multicenter Study Clinical Trial
Effectiveness and safety of the low-molecular-weight heparin CY 216 in the prevention of fatal pulmonary embolism and thromboembolic death in general surgery. A multicentre, double-blind, randomized, controlled clinical trial versus placebo (STEP). STEP Study Group.
Deep venous thrombosis is very frequent after general surgery, and its major complication, pulmonary embolism, is today the most frequent cause of postoperative death. The reduction of this cause of mortality is mainly based on its prevention rather than its therapy. This purpose was achieved by using physical and pharmacological means. ⋯ Eight (0.36%) belonged to the CY 216 group and 18 (0.80%) to the placebo group. In the CY 216 group, pulmonary embolism was the direct cause of death in 2 patients (0.09%), while the remaining 6 deaths could not be ascribed either directly or indirectly to thrombosis. In the placebo group, pulmonary embolism was the cause of death in 4 cases (0.18%; p less than 0.05) and contributed to death in 4.(ABSTRACT TRUNCATED AT 400 WORDS)
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Prog. Clin. Biol. Res. · Jan 1990
Multicenter Study Clinical TrialInterceed (TC7) as an adjuvant for adhesion reduction: clinical studies.