EUCTR2019-003795-39-FI进行中（未招募）1 期
Premedication with intranasal dexmedetomidine in sedation of patients undergoing total knee arthroplasty (TKADEX) - a prospective, double blinded randomized controlled trial - TKADEX
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
- 80
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. The patient is scheduled for elective unilateral total knee arthroplasty (TKA) under spinal anesthesia
- •2. Fluent skills in finnish language (to understand the given information and to be able to give informed consent and communicate with the study personnel)
- •3. Age between 35 and 80 years
- •4. Weight between 50 and 100 kg
- •5. ASA (American Society of Anesthesiologists) status 1-3
- •6. Written informed consent from the patient
- •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 80
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 80
排除标准
- •1. A previous history of intolerance to the study drug or related compounds and additives
- •2. Disease or condition affecting patient’s ability to give written informed consent
- •3. Existing or recent significant disease possible affecting absorption, distribution, metabolism, excretion or response to the study drug
- •4. History of cardiac disease (valvular insufficiency, severe left ventricular dysfunction) or abnormal ECG rhythm (bradycardia < 50/min, 2nd or 3rd degree AV-block, pacemaker)
- •5. Chronic opioid use or use of other analgesic adjuvants such as pregabalin, gabapentin, amitriptyline or duloxetine
- •6. Participation in any other study concomitantly or within one month prior to the entry into this study
- •7. Clinically significant abnormal findings in physical examination or laboratory screening
- •8. Use of drugs or natural products known to cause enzyme induction or inhibition
- •9. Pregnancy or breastfeeding
- •10. A previous intolerance to non-steroidal anti-inflammatory drugs (NSAIDs)
- •11. Preoperative systolic blood pressure <110mmHg
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