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.
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: 1. To study the efficacy of Cytoflavin® administered in elderly patients age for the prevention of cognitive decline after major surgery. 2. To study the safety and tolerability of Cytoflavin® in elderly patients for after major surgery.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
200
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).
Regional Clinical Hospital № 3
Chelyabinsk, Russia
Central Clinical Hospital with a polyclinic of the Office of the President of the Russian Federation
Moscow, Russia
Alexandrovskaya City Hospital
Saint Petersburg, Russia
City Hospital №15
Saint Petersburg, Russia
City Hospital №38 named after N.A. Semashko
Saint Petersburg, Russia
City Hospital №40 of the Kurortny District
Saint Petersburg, Russia
Hospital for War Veterans
Saint Petersburg, Russia
I. P. Pavlov 1st St. Petersburg State Medical University
Saint Petersburg, Russia
Military Medical Academy named after S.M. Kirov
Saint Petersburg, Russia
Pokrovskaya City Hospital
Saint Petersburg, Russia
...and 3 more locations
Montreal Cognitive Assessment (MoCA) scale score
The MoCA test is a one-page 30-point test, ranging between 0 and 30, where 0 is the worst and 30 is the best result; a score of 26-30 or over is considered to be normal. Outcome measure is the change in the MoCA scale score by the end of the treatment course compared with the preoperative score.
Time frame: 32 days
The Mini-Mental State Examination (MMSE) scale
MMSE test is a 30-point questionnaire; any score greater than or equal to 24 points (out of 30) indicates a normal cognition; below this, scores can indicate severe (≤9 points), moderate (10-18 points) or mild (19-23 points) cognitive impairment. Outcome measure will be the change of MMSE scale score by the end of the treatment course compared to the preoperative score
Time frame: 32 days
The Mini-Mental State Examination (MMSE) follow-up score
MMSE test is a 30-point questionnaire; any score greater than or equal to 24 points (out of 30) indicates a normal cognition; below this, scores can indicate severe (≤9 points), moderate (10-18 points) or mild (19-23 points) cognitive impairment. Outcome measure will be the change of MMSE scale score by the end of the follow-up period
Time frame: 90 days
Montreal Cognitive Assessment (MoCA) follow-up
The MoCA test is a one-page 30-point test, ranging between 0 and 30, where 0 is the worst and 30 is the best result; a score of 26-30 or over is considered to be normal. Outcome measure is the change of the MoCA scale score by the end of the follow-up period
Time frame: 90 days
Median group Mini-Mental State Examination (MMSE) score
MMSE test is a 30-point questionnaire; any score greater than or equal to 24 points (out of 30) indicates a normal cognition; below this, scores can indicate severe (≤9 points), moderate (10-18 points) or mild (19-23 points) cognitive impairment. Outcome measure will be the difference between median group total scores on the MMSE scale.
Time frame: day 7, 32, 90
Median Montreal Cognitive Assessment (MoCA) scale score
The MoCA test is a one-page 30-point test, ranging between 0 and 30, where 0 is the worst and 30 is the best result; a score of 26-30 or over is considered to be normal. Outcome measure is the difference in median group values of the MOCA scale
Time frame: day 7, 32, 90
Proportion of postoperative delirium
The proportion of patients who developed postoperative delirium in the first 96 hours after surgery according to the results of CAM-ICU
Time frame: day 3-6
Length of stay in the ICU
Length of stay in the ICU
Time frame: day 32
Mortality
Mortality in the postoperative period in the experimental and control groups
Time frame: day 32
Postoperative cognitive decline
The proportion of patients with a decrease in the results of two or more neuropsychological tests by more than 20% by the end of the treatment course and by the end of the follow-up period compared the baseline values
Time frame: day 32, day 90
Quality of life score
Change in the overall score for the EQ-5D questionnaire for assessing the quality of life
Time frame: day 90
Independence and activity
The proportion of patients dependent in at least two daily functions according to the results of the Katz Daily Activity Index at the end of the treatment course
Time frame: day 32
Anxiety/depression
The group average score by Hospital Anxiety and Depression Scale (HADS) at the end of the treatment course and at the end of the follow-up period. The HADS is a fourteen item scale, a person can score between 0 and 21 for either anxiety or depression, where scores on each scale can be interpreted in ranges: normal (0-7), mild (8-10), moderate (11-14) and severe (15-21).
Time frame: day 32, day 90
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