EUCTR2012-005701-43-FR进行中（未招募）1 期
Therapeutic Equivalence Study of Propofol Using Target-Controlled Infusion of Propofol 2% (20 mg/mL) MCT Fresenius Compared with Diprivan® 20 mg/mL (AstraZeneca) in Patients Undergoing Elective Surgery
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 71
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
- •1. Male or female subjects =18 years and <65 years old
- •2. Able to understand and give signed and dated written informed consent
- •3. Body mass index (BMI) =20 and =30 kg/m2 at screening
- •4. ASA physical status 1 or 2
- •5. Undergoing elective, minor orthopaedic, vascular, urological, or gynaecological surgery
- •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 70
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •1. The following planned procedures are to be excluded:
- •- Day surgery
- •- Emergency surgery
- •- Total hip or total knee replacement
- •- Requiring opening of the great cavities of the body (cranium, thorax, peritoneum, or pelvis)
- •- With routine risk, even if low, of haemorrhage severe enough to require administration or colloid or blood products
- •- With routine risk, even if low, of death during or soon after the procedure
- •- Vascular surgery involving the aorta, venae cavae, iliac arteries, or femoral arteries
- •2. Intended administration of IV medications through a central venous catheter
- •3. Administration of general anaesthesia or propofol within the 7 days prior to randomisation
- •4. History of hypersensitivity to propofol, eggs, Soya, peanuts, or any other constituent of the study drugs
- •5. ASA physical status =3
- •6. History of major anaesthesia complications
- •7. History of difficult airway management
- •8. History of difficult venous access
- •9. Myocardial infarction within 6 months of randomisation or a cardiac reperfusion procedure within 6 weeks of randomisation
- •10. Significant respiratory, cardiovascular, liver or renal disease as assessed by Investigator
- •11. Active systemic infection (localised infection related to surgical procedure is allowable as long as there is no indication of systemic involvement)
- •12. History of psychiatric disorder, including use of sedatives or antidepressants for any reason, within 6 months prior to randomisation
- •13. Alcohol or other substance abuse within 2 years prior to randomisation, as well as for the duration of the study
- •14. Use of medication that could reduce the subject’s respiratory and cardiac output
研究者
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