A Randomized Trial of Creatine-kinase Leak After Rosuvastatin in Elective Percutaneous Coronary Intervention (CLEAR-PCI).

OBJECTIVES: To determine the impact of percutaneous coronary intervention (PCI) performed at the same time of the peak concentration of rosuvastatin to reduce periprocedural myocardial infarction (PMI). BACKGROUND: Prior studies suggest that a high dose of statin before PCI reduce periprocedural myocardial infarction. However, there is no information regarding the elective PCI performed at the time of the peak of statin concentration to reduce PMI. METHODS: From 2001 to 2013, at a single center in Brazil we enrolled 544 patients who underwent elective PCI and after exclusions for baseline biases in clinical and angiographic characteristics, yielding 528 patients, we prospectively randomly assigned them to either a high loading dose of Rosuvastatin before PCI (n = 264) or standard treatment (n = 264). After exclusions for biases in procedural characteristics a total of 487 patients underwent to end points analysis. The primary outcome was the incidence of MB fraction of creatine kinase (CK-MB) greater than three times the upper limit of normal. RESULTS: The primary end point occurred in 7.6% in the rosuvastatin and 4.8% in the control group (P = 0.200). There was a higher incidence in elevation of CK-MB than normal baseline in the rosuvastatin (67.1% vs 59.2%, P = 0.701). There was no difference in major adverse event (0% in the rosuvastatin group vs 0.8% in control).

Neurotoxicity of subarachnoid preservative-free S(+)-ketamine in dogs.

BACKGROUND: Subarachnoid S(+)-ketamine is a matter of much debate as the results regarding its toxicity are contradictory. OBJECTIVES: Our objective was to investigate possible histopathological alterations after subarachnoid administration of different doses of preservative-free S(+)-ketamine to dogs. STUDY DESIGN: A randomized, blind, prospective experimental study. SETTING: Center for Research on Pain at the Federal University of Maranhão, Brazil. METHODS: Sixteen adult mongrel dogs of both sexes, each weighing 11 to 20 kg were divided into 3 groups: Group I (n=6), 0.7 mg/kg-1 S(+)-ketamine; Group II (n=6), 0.5 mg/kg-1 S(+)-ketamine, and a control group, Group III, (n=4), 0.9% NaCl. All substances were administered in one mL volume doses. The animals were kept in captivity for 2 weeks; after this period, they were put down and lumbar and sacral portions of the spinal cords were removed for histological examination using conventional light microscopy. RESULTS: There were histological alterations in the spinal cords of the test subjects in the control group. Comparison showed significant histological abnormalities in Groups I and II when compared to the control group, including gliosis, axonal edema, central chromatolysis, lymphocyte infiltration and fibrous thickening of the dura mater. LIMITATIONS: Test subjects received only a single dose each. The observation period was not very long, less than a month. CONCLUSIONS: Subarachnoid administration of S(+)-ketamine without preservative caused histological lesions on the spinal cord and meninges in the dogs studied. S(+)-ketamine should not be given to clinical patients in this way until further evaluation of the significance of this toxicity has been conducted.

Prospective randomized controlled trial comparing 2 versions of laparoscopic ileal interposition associated with sleeve gastrectomy for patients with type 2 diabetes with BMI 21-34 kg/m(2).

BACKGROUND: The objective of the present study was to prospectively evaluate the results of 2 versions of laparoscopic ileal interposition (II) and sleeve gastrectomy (SG) for the treatment of patients with type 2 diabetes mellitus and body mass index of 21-34 kg/m(2). METHODS: The laparoscopic procedures were prospectively and randomly performed in 38 patients. Of the 38 patients, 18 underwent the first version (II-SG) and 20 underwent the second version in which a diversion of the second portion of the duodenum was applied (II-DSG) and a segment of ileum was interposed into the proximal duodenum. The groups were comparable regarding age (56 and 50 years); gender (13 men and 5 women and 14 men and 6 women); weight (78 and 86 kg); mean BMI (27 and 29 kg/m(2)); duration of type 2 diabetes mellitus (10.1 and 9.2 years); the presence of dyslipidemia (12 and 8 patients), micro- and macroalbuminuria (9 and 9 patients), hypertension (8 and 15 patients), and retinopathy (5 and 8 patients); and the use of antidiabetic medications and the hemoglobin A1c level (8.6% and 8.4%). All patients were followed up for >or=2 years. RESULTS: The mean hospital stay was 3.4 days for the II-SG and 3.5 days for the II-DSG group. No patient required reoperation. All patients in both groups achieved lower levels of hemoglobin A1c. In the II-SG group, the mean hemoglobin A1c level was 6.35% (range 4.9-8.1). In the II-DSG group, the mean hemoglobin A1c level was 5.39% (range 4.2-6.5%). The mean BMI decreased in both groups to 22.2 kg/m(2) in the II-SG group and 22.7 kg/m(2) in the II-DSG group. Normal cholesterol levels (<200 mg/dL) were observed in 95% of the II-SG group and 100% of the II-DSG group. The triglycerides were lower than 150 mg/dL in 73% of the II-SG group and 90% of the II-DSG group after 24 months. CONCLUSION: Laparoscopic II-SG and II-DSG were safe and effective operations for controlling type 2 diabetes mellitus in a nonobese (BMI 21-34 kg/m(2)) population.