A Lithium-Based Medication to Improve Neurological Outcomes After Surgical Carotid Reconstruction
- Conditions
- Interventions
- Registration Number
- NCT05126238
- Lead Sponsor
- Negovsky Reanimatology Research Institute
- Brief Summary
There are 10.3 million cases of stroke registered in the world every year; 63% of them lead to death. According to World Health Organization, stroke is one of the most important risk factors of death and early disability.
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- Detailed Description
There are 10.3 million cases of stroke registered in the world every year; 63% of them lead to death. According to World Health Organization, stroke is one of the most important risk factors of death and early disability.
...
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 500
- age > 18 years
- elective carotid artery surgery
- general anesthesia
- written informed consent
- urgent surgery
- recent ( < 1 month) overt stroke
- Mini-mental State Examination < 20 points
- The presence of any mental disorder according to the International Classification of Diseases 11th Revision which is confirmed by a psychiatrist.
- The presence of any neuromuscular disease according to the International Classification of Diseases 11th Revision
- Hypersensitivity or known allergy to lithium carbonate
- History of seizure disorder
- History of leukemia
- Estimated glomerular filtration rate < 30 ml/min/1.73 m2
- Left ventricular ejection fraction < 30%
- Heart failure equal 3 or 4 class according to the New York Heart Association Functional Classification
- Pregnant or breast-feeding women
- Inability to undergo a preoperative assessment for any reason
- Previously enrolled in this trial
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Placebo Placebo In preoperative period patients will take placebo on 1-1-1 regimen during 2 days prior to surgery. On the day of surgery, they will take placebo 2 hours before surgery. After the surgery, patients will take placebo in the afternoon and in the evening. Lithium Lithium Carbonate In preoperative period patients will take 300mg of lithium carbonate on 1-1-1 regimen during 2 days prior to surgery. On the day of surgery, they will take 300mg of lithium carbonate 2 hours before surgery. After the surgery, patients will take 300mg of lithium carbonate in the afternoon and 300mg of lithium carbonate in the evening.
- Primary Outcome Measures
Name Time Method Frequency of emergence delirium 30 days Number of patients with positive the confusion assessment method for the intensive care unit as soon as they reach Aldrete score of 9 points
- Secondary Outcome Measures
Name Time Method Frequency of covert strokes 1 year Number of covert strokes
Serum level of Tau-protein 2 days after surgery Serum level of Tau-protein
Length of postoperative delirium until 1 month after surgery 30 days - number of days in which patient had positive confusion assessment method for the intensive care unit or 3-minute confusion assessment method
Frequency of major adverse cardiac event 1 year Number of major adverse cardiac events
Serum level of neuron-specific enolase 2 days after surgery Serum level of neuron-specific enolase
Length of hospitalization 1 month Number of days in hospital
Frequency of leukocytosis From 2 days before surgery to the day of surgery Number of patients with leukocytosis
Frequency of postoperative nausea and vomit 1 month Number of patients with postoperative nausea and vomit
Frequency of preoperative seizure From 2 days before surgery to the day of surgery Number of patients with seizure
Frequency of postoperative delirium 30 days Number of patients with even one positive confusion assessment method for the intensive care unit or 3-minute confusion assessment method
Frequency of cardiac death 1 year Number of of cardiac deaths
Frequency of non-fatal cardiac arrest 1 year Number of non-fatal cardiac arrests
1-year mortality 1 year Number of deaths in period of 1 year after surgery
Frequency of acute diarrhea From 2 days before surgery to the day of surgery Number of patients with acute diarrhea
Frequency of agitation 30 days Richmond agitation-sedation scale more or equal +2 evaluated from the end of volatile anesthetic supply to the moment when a patient reaches Aldrete score of 9 points
Richmond agitation-sedation scale:
...Length of stay in intensive care unit 1 month Number of days in intensive care unit
Frequency of preoperative nausea and vomit From 2 days before surgery to the day of surgery Number of patients with preoperative nausea and vomit
Frequency of acute kidney injury 1 month Number of patients with acute kidney injury
Frequency of myasthenia From 2 days before surgery to the day of surgery Number of patients with myasthenia
Serum level of S100 beta protein 2 days after surgery Serum level of S100 beta protein
Serum level of Neurofilament light polypeptide 2 days after surgery Serum level of Neurofilament light polypeptide
Serum level of Glial fibrillary acidic protein 2 days after surgery Serum level of Glial fibrillary acidic protein
Frequency of overt strokes 1 year Number of overt strokes
Frequency of major adverse cardiac and cognitive event 1 year Number of major adverse cardiac and cognitive events
30-days mortality 30 days Number of deaths in period of 30 days after surgery
Frequency of new postoperative arrhythmia 1 month Number of new postoperative arrhythmias
Frequency of postoperative seizure 1 month Number of patients with seizure
Trial Locations
- Locations (2)
Vishnevsky Center of Surgery
🇷🇺Moscow, Russian Federation
Demikhov Municipal Clinical Hospital 68
🇷🇺Moscow, Russian Federation