EUCTR2013-000823-15-DE进行中（未招募）1 期
europrotection with Dexmedetomidine in patients undergoing elective cardiac or abdominal surgery - NEUPRODEX
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
- 77
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
入选标准
- •1.Patients aged = 60 years
- •2.Male and female patients undergoing elective cardiac (elective CABG-surgery without valve surgery with left ventricular ejection fraction = 30%) or pancreatic or hepatic or intestinal or gastric surgery of both Campus Charité Mitte and Campus Virchow - Klinikum, Charité – University Medicine Berlin
- •3.Offered patient information and written consent by the patient (according to AMG § 40 (1) 3b)
- •4.Premedication only with benzodiazepines
- •5.Paintherapy during the operation with regional procedures and/or Sufentanil/Fentanyl
- •6.Anesthesia in cardioasurgery according to Heart-Lung-Apparatus
- •7.Anesthesia with hypnoticum Propofol
- •8.Paintherapy after operation according to S3-Guideline
- •9.Postoperative medication for anxiolysis only with benzodiazepines
- •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 7
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 70
排除标准
- •1.Known drug intolerance/allergy: dexmedetomidine or to other ingredients
- •2.Lacking willingness to save and hand out pseudonymised data within the clinical trial
- •3.Accommodation in an institution due to an official or judicial order
- •(according to AMG §40 (1) 4)
- •4. Employee of the Charité - University - Medicine Berlin CVK/CCM
- •5. Illiteracy
- •6. Inability to speak and/or read German
- •7. Minimal mental status examination (MMSE) < 24
- •8. Severe hearing loss or visual impairment
- •9. Acute brain injury
- •10. Intracranial haemorrhage within one year before participation in the study
- •11. Manifest psychiatric disease
- •12. Known illicit substance abuse
- •13. Acute intoxication
- •14. For women: Pregnancy or positive pregnancy test within the preoperative screening
- •15. Homeless or other circumstances, where the patient would not be reachable by telephone or postal services for the 3-months follow up
- •16. Participation in another interventional clinical trial according to the German Drug Law at time of inclusion and during the trial
- •17. Acute circulatory failure at time of randomisation (severe hypotension with mean arterial pressure < 55 mmHg despite vasopressors or optimal preload)
- •18. AV-conduction-block II or III (unless pacemaker installed)
- •19. Severe bradycardia (heart-rate < 50 bpm, preoperative, permanent)
- •20. Spinal cord injury with known autonomic dysregulation
- •21. Preoperative acute cerebrovascular event with neurologic residues
- •22. Liver insufficiency (Child C cirrhosis, MELD Score > 17)
- •23. Aplication of Remifentanil during the operation
- •24. Postoperatively planned deep sedation (RASS, -4 to -5)
- •25. Administration of Clonidin during administration of the study drug
- •26. Additional administration of Dexmedetomidine within 3 months after study inclusion
研究者
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