Title
Efficacy and Safety of Cytoflavin® Used in Elderly Patients for the Prevention of Cognitive Decline After Major Surgery
A Multicentre Double-blind Placebo-controlled Randomized Study of Efficacy and Safety of Cytoflavin®, Intravenous Administration and Enteric-coated Tablets, Used in Elderly Patients for Prevention of Cognitive Decline After Major Surgery
Phase
Phase 3Lead Sponsor
Polysan, Ltd.Study Type
InterventionalStatus
Completed No Results PostedIndication/Condition
Cognitive DysfunctionIntervention/Treatment
Cytoflavin® enteric-coated tablet [inosine (114487), nicotinamide (80160), riboflavin (109006), sodium succinate (109242)] ...Study Participants
200Postoperative 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.
Cytoflavin® (Inosine + Nicotinamide + Riboflavin + Succinic Acid) is a combination drug, which improves coronary and cerebral blood flow, activates metabolic processes in the central nervous system, restores impaired consciousness, promotes regression of neurological symptoms and improvement of cognitive functions of the brain. It has a quick awakening effect in post-anesthetic depression of consciousness. The positive effect of Cytoflavin® on cognitive function has been previously shown in patients with dyscirculatory encephalopathy and acute stroke, as well as in a population of patients during cardiac surgery in cardiopulmonary bypass and working heart. The present study aims to evaluate the opportunity of prevention of postoperative cognitive decline by administration of Cytoflavin® at a sequential regimen, starting from intravenous infusions and followed by oral intake during 1 month.
Study objectives:
To study the efficacy of Cytoflavin® administered in elderly patients age for the prevention of cognitive decline after major surgery.
To study the safety and tolerability of Cytoflavin® in elderly patients for after major surgery.
Single drip infusion of 20 ml of Cytoflavin® solution in 200 ml of 0.9%NaCl intravenously once a day
2 tablets, orally, with 100 ml of drinking water, 30 minutes before meals, 2 times a day, with an interval of 8-10 hours (but no later than 18:00).
Single drip infusion of 20 ml of placebo solution in 200 ml of 0.9%NaCl intravenously once a day
2 tablets, orally, with 100 ml of drinking water, 30 minutes before meals, 2 times a day, with an interval of 8-10 hours (but no later than 18:00).
Patients of group I will receive the experimental drug Cytoflavin®, manufactured by POLYSAN (Russia), on the day before surgery, during the surgical intervention, and in the postoperative period. Cytoflavin® solution(Inosine + Nicotinamide + Riboflavin + Succinic Acid) will be administered IV for 7 days, and Cytoflavin® enteric-coated tablets (Inosine + Nicotinamide + Riboflavin + Succinic Acid) will be administered for 25 days (in total 32 days of treatment).
Patients of group II will receive placebo (manufactured by POLYSAN, Russia), on the day before surgery, during the surgical intervention, and in the postoperative period. Placebo solution will be administered IV for 7 days, and placebo enteric-coated tablets will be administered for 25 days (in total 32 days of treatment).
Inclusion Criteria: Signed informed consent Men and women aged 60-80 years, inclusive. Planned cardiac surgery, which does not assume the use of a cardiopulmonary bypass. Planned or delayed orthopedic surgery (hip joint endoprosthetics, osteosynthesis for fractures of the proximal third of the hip, etc.), under general or combined anesthesia. Legal capacity of the patient Absence of dementia (MoCA≥17, MMSE≥19) Lack of reproductive potential or Consent to use adequate methods of contraception Exclusion Criteria: Hypersensitivity to any component of the study drug Emergency surgery Repeated surgery or reoperation Anesthesia risk ASA≥5 Severe visual or hearing impairment which impedes the performance of neuropsychological tests Operation under general anesthesia in the previous 3 months Severe renal failure requiring replacement of renal function (dialysis) Severe hepatic failure (class C and above in Child-Pugh) Chronic obstructive pulmonary disease Terminal stage of other chronic incurable diseases Decompensated diabetes A history of oncological diseases, mental illness, HIV infection, syphilis, tuberculosis, alcohol or drug addiction The use of 5 or more units of alcohol per week in the previous 3 months Diagnosis of mental or neurodegenerative disease (e.g. schizophrenia, Parkinson's disease, clinically manifest depression) Permanent intake of psychotropic drugs (neuroleptics, tranquilizers, antidepressants) Course intake of nootropic drugs in the previous 3 months 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. The presence in the history of any significant, according to the physician-researcher, condition that prevents the inclusion of the patient in the study. Participation in any clinical study in the previous 3 months Employees of the study centres and their family members.
