Efficacy and Safety of Cytoflavin® Used in Elderly Patients for the Prevention of Cognitive Decline After Major Surgery

• Status: Completed
• Trial end date: 2019-07-11
• Target enrollment: 0
• Participant gender: All

Summary

Postoperative cognitive impairment develops in the early and continues in the late postoperative period; it is manifested by impaired memory, attention, concentration and other higher cortical functions (thinking, speech). Early studies demonstrated the positive impact of perioperative administration of Cytoflavin (Inosine + Nicotinamide + Riboflavin + Succinic Acid), which prevented impairments of intelligence, speech, and attention after cardiac surgery, both in conditions of cardiopulmonary bypass and on a working heart. The aim of the present study is to evaluate the safety and efficacy of Cytoflavin for the prevention of cognitive disorders after major surgeries performed in elderly patients.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: POLYSAN Scientific & Technological Pharmaceutical Company; Scientific Technological Pharmaceutical Firm Polysan, Ltd.
• Treatments: Flavin Mononucleotide; Niacin; Niacinamide; Nicotinic Acids; Pharmaceutical Solutions; Povidone; Riboflavin

Criteria

Inclusion Criteria:

1. Signed informed consent

2. Men and women aged 60-80 years, inclusive.

3. Planned cardiac surgery, which does not assume the use of a cardiopulmonary bypass.

4. Planned or delayed orthopedic surgery (hip joint endoprosthetics, osteosynthesis for fractures of the proximal third of the hip, etc.), under general or combined anesthesia.

5. Legal capacity of the patient

6. Absence of dementia (MoCA≥17, MMSE≥19)

7. Lack of reproductive potential or

8. Consent to use adequate methods of contraception

Exclusion Criteria:

1. Hypersensitivity to any component of the study drug

2. Emergency surgery

3. Repeated surgery or reoperation

4. Anesthesia risk ASA≥5

5. Severe visual or hearing impairment which impedes the performance of neuropsychological tests

6. Operation under general anesthesia in the previous 3 months

7. Severe renal failure requiring replacement of renal function (dialysis)

8. Severe hepatic failure (class C and above in Child-Pugh)

9. Chronic obstructive pulmonary disease

10. Terminal stage of other chronic incurable diseases

11. Decompensated diabetes

12. A history of oncological diseases, mental illness, HIV infection, syphilis, tuberculosis, alcohol or drug addiction

13. The use of 5 or more units of alcohol per week in the previous 3 months

14. Diagnosis of mental or neurodegenerative disease (e.g. schizophrenia, Parkinson's disease, clinically manifest depression)

15. Permanent intake of psychotropic drugs (neuroleptics, tranquilizers, antidepressants)

16. Course intake of nootropic drugs in the previous 3 months

17. Communicative, sensory, motor, or any other deficiency that does not allow the patient to adequately assess their behavior and correctly fulfill the conditions of the study protocol.

18. The presence in the history of any significant, according to the physician-researcher, condition that prevents the inclusion of the patient in the study.

19. Participation in any clinical study in the previous 3 months

20. Employees of the study centres and their family members.