europrotection with Dexmedetomidine in patients undergoing elective cardiac or abdominal surgery

Phase 1

• Conditions: The drug Dexmedetomidine will be investigated in patients (men and women) undergoing elective cardiac or abdominal surgery. The study medication will be administered perioperatively by intravenous infusion continously (at the longest 48 h) to prevent/reduce the rate of Delirium and the incidence of POCD.; Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Anesthesia and Analgesia [E03]

• Registration Number: EUCTR2013-000823-15-DE
• Lead Sponsor: Charité – Universitätsmedizin Berlin

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2013-11-19
• Last Update Posted: 1 February 2020

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Not specified
• Target Recruitment: 77

Inclusion Criteria

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

Exclusion Criteria

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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified