Efficacy and Safety of Cytoflavin® Used in Elderly Patients for the Prevention of Cognitive Decline After Major Surgery
Condition: Cognitive Dysfunction
MeSH terms: Cognitive Dysfunction
Study type: Interventional
Phase: Phase 3

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.
    

Detailed description: 
      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.
    

Intervention name(s): Cytoflavin® solution; Cytoflavin® enteric-coated tablet; Placebo solution; Placebo enteric-coated tablet
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): 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).
Other intervention name(s): Inosine + Nicotinamide + Riboflavin + Succinic Acid solution; Inosine+Nicotinamide+Riboflavin+Succinic Acid tablet; riboflavin; meglumine, soduim hydroxide, water; povidone, calcium stearate, hypromellose, polysorban, dyes
Intervention MeSH terms: Niacinamide; Niacin; Nicotinic Acids; Riboflavin; Flavin Mononucleotide; Povidone; Pharmaceutical Solutions
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: postoperative cognitive decline