EUCTR2012-004383-22-DE进行中（未招募）1 期
Perioperative complications in obese and non-obese patients: Prevention and treatment of wound infections and post-operative pain.Prospective, open, monocentric study to investigate perioperative tissue concentrations of antibiotics and regional analgesics using microdialysis in obese and non-obese patients. - Microdialysis
niversity of Leipzig0 个研究点开始时间: 2013年1月15日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •-Obese (BMI = 35 kg/m2)
- •-age = 18 years
- •-patients undergoing an abdominal surgery and needing a perioperative prophylactic antibiotic and analgesics
- •-Written informed consent of the patient
- •Control group:
- •- BMI = 18,5 kg/m² und BMI < 30 kg/m²
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 90
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 90
排除标准
- •Exclusion Kriteria – Drug Group 1 (Linezolid, Meropenem and Paracetamol/Metamizol):
- •-Patients who have received the study medication within the 72 hours before surgery
- •-known allergic reactions, hypersensitivity or contra-indications to Propacetamol-HCl or Metamizol-Sodium, Carbapenem-Antibiotics, ß-Laktam-Antibiotics (e.g. Penicilline, Cephalosporine), Pyrazolone und Pyrazolidine
- •-sever liver insufficiency
- •-Patients with disorders of bone marrow functions (e.g. after treatment with cytostacics) or disorders of the hematopoiesis system
- •-genetic induced Glucose-6-phosphate dehydrogenase deficiency
- •-acute hepatic porphyria
- •-existing hypotony
- •-patients with phenylketonuria or hereditary fructose-intolerance
- •-within the previous tow weeks intake of drugs, which inhibit Monoaminooxidase A or B (e.g. Phenelzin, Isocarboxazid, Selegilin, Moclobemid)
- •-pregnant or breast-feeding women (positive pregnancy test for pre-menopausal women)
- •-participation in another interventional AMG study (studies falling in the jurisdiction of German Drug Law)
- •Exclusion Kriteria – Drug Group 2 (Tigecyclin and Paracetamol/ Metamizol):
- •-Patients who have received the study medication within the 72 hours before surgery
- •-known allergic reactions, hypersensitivity or contra-indications to Propacetamol-HCl or Metamizol-Sodium, Tigecycline, Tetracycline Antibiotics
- •-sever liver insufficiency
- •-Patients with disorders of bone marrow functions or disorders of the hematopoiesis system
- •-genetic induced Glucose-6-phosphate dehydrogenase deficiency (risk of hemolysis)
- •-acute hepatic porphyria
- •-existing hypotony
- •-pregnant or breast-feeding women (positive pregnancy test for pre-menopausal women)
- •-participation in another interventional AMG study (studies falling in the jurisdiction of German Drug Law)
- •Exclusion Kriteria – Drug Group 3 (Cefazolin, Metronidazol and Paracetamol/Metamizol):
- •-Patients who have received the study medication within the 72 hours before surgery
- •-known allergic reactions, hypersensitivity or contra-indications to Propacetamol-HCl or Metamizol-Sodium, Cephalosporins, other Cephalosporins, 5-Nitroimidazoles
- •-sever liver insufficiency
- •-Patients with disorders of bone marrow functions or disorders of the hematopoiesis system
- •-genetic induced Glucose-6-phosphate dehydrogenase deficiency (risk of hemolysis)
- •-acute hepatic porphyria
- •-existing hypotony
- •-compromised renal function (creatinine-clearance < 35 ml/min)
- •-pregnant or breast-feeding women (positive pregnancy test for pre-menopausal women)
- •-participation in another interventional AMG study (studies falling in the jurisdiction of German Drug Law)
研究者
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