A Phase 3 interventional study of Lithium Carbonate and Placebo in Carotid Artery Diseases and Carotid Artery Stenosis, sponsored by Negovsky Reanimatology Research Institute. Terminated at 1 site in Russia. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-09-25.
Sponsored by Negovsky Reanimatology Research Institute · Phase 3, Interventional, and Treatment
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.
Carotid artery surgery is a gold standard of hemodynamically significant carotid artery disease treatment. According to some trials, carotid artery surgery decreases the 2-years mortality.
The most important part of carotid artery surgery is a temporary absence of blood flow in the carotid artery. The duration of this period is a crucial characteristic of this type of surgery. The absence of blood flow leads to brain ischemia which is the risk factor of postoperative neurocognitive disorders such as emergence delirium, postoperative delirium and postoperative cognitive dysfunction.
Some surgical and non-surgical methods for brain protection were evaluated. According to recent data, there is no evidence of effective pharmacological protective methods that can decrease brain damage during carotid artery surgery.
Nevertheless, some trials demonstrated that using lithium-based medications for patients with a stroke can reduce the volume of the stroke. Therefore, the investigators want to check the hypothesis that using lithium-based medication in the preoperative period can reduce brain damage during carotid artery surgery.
The objectives of this trial:
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.
Carotid artery surgery is a gold standard of hemodynamically significant carotid artery disease treatment. According to some trials, carotid artery surgery decreases the 2-years mortality.
The most important part of carotid artery surgery is a temporary absence of blood flow in the carotid artery. The duration of this period is a crucial characteristic of this type of surgery. The absence of blood flow leads to brain ischemia which is the risk factor of postoperative neurocognitive disorders such as emergence delirium, postoperative delirium and postoperative cognitive dysfunction.
Some surgical and non-surgical methods for brain protection were evaluated. According to recent data, there is no evidence of effective pharmacological protective methods that can decrease brain damage during carotid artery surgery.
Nevertheless, some trials demonstrated that using lithium-based medications for patients with a stroke can reduce the volume of the stroke. Therefore, the investigators want to check the hypothesis that using lithium-based medication in the preoperative period can reduce brain damage during carotid artery surgery.
The objectives of this trial:
To determine if Lithium carbonate is superior to placebo for the occurrence of emergence delirium, agitation, postoperative delirium and postoperative cognitive dysfunction.
To determine if Lithium carbonate is non-inferior to placebo for the occurrence of a new arrhythmia, leukocytosis, acute kidney injury, seizure disorders, diarrhea, nausea, and vomit.
248 studies on the registry are indexed under Carotid Artery Diseases; 56 are open to participants now.
This study's enrollment of 107 is below the median of 120 across 118 interventional studies indexed under Carotid Artery Diseases.
Browse Carotid Artery Diseases studies →Negovsky Reanimatology Research Institute is the lead sponsor of 10 studies on the registry; 2 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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.
Drug: Lithium Carbonate
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.
Drug: Placebo
In preoperative period patients will take 300 mg 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.
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 placebo 2 hours before surgery.
Frequency of emergence delirium
Number of patients with positive the confusion assessment method for the intensive care unit as soon as they reach Aldrete score of 9 points
Time frame: 30 days
Frequency of agitation
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: minimum value = -5 (Unarousable - no response to voice or physical stimulation) maximum value = +4 (Combative - overtly combative or violent; immediate danger to staff) Adequate patients have the results of Richmond agitation-sedation score equal 0 (Alert and calm; Spontaneously pays attention to caregiver)
Time frame: 30 days
Frequency of postoperative delirium
Number of patients with even one positive confusion assessment method for the intensive care unit or 3-minute confusion assessment method
Time frame: 30 days
Length of postoperative delirium
30 days - number of days in which patient had positive confusion assessment method for the intensive care unit or 3-minute confusion assessment method
Time frame: until 1 month after surgery
Frequency of overt strokes
Number of overt strokes
Time frame: 1 year
Frequency of covert strokes
Number of covert strokes
Time frame: 1 year
Length of stay in intensive care unit
Number of days in intensive care unit
Time frame: 1 month
Length of hospitalization
Number of days in hospital
Time frame: 1 month
Frequency of cardiac death
Number of of cardiac deaths
Time frame: 1 year
Frequency of non-fatal cardiac arrest
Number of non-fatal cardiac arrests
Time frame: 1 year
Frequency of major adverse cardiac event
Number of major adverse cardiac events
Time frame: 1 year
Frequency of major adverse cardiac and cognitive event
Number of major adverse cardiac and cognitive events
Time frame: 1 year
30-days mortality
Number of deaths in period of 30 days after surgery
Time frame: 30 days
1-year mortality
Number of deaths in period of 1 year after surgery
Time frame: 1 year
Frequency of new postoperative arrhythmia
Number of new postoperative arrhythmias
Time frame: 1 month
Frequency of leukocytosis
Number of patients with leukocytosis
Time frame: From 2 days before surgery to the day of surgery
Frequency of acute diarrhea
Number of patients with acute diarrhea
Time frame: From 2 days before surgery to the day of surgery
Frequency of postoperative nausea and vomit
Number of patients with postoperative nausea and vomit
Time frame: 1 month
Frequency of preoperative nausea and vomit
Number of patients with preoperative nausea and vomit
Time frame: From 2 days before surgery to the day of surgery
Frequency of acute kidney injury
Number of patients with acute kidney injury
Time frame: 1 month
Frequency of myasthenia
Number of patients with myasthenia
Time frame: From 2 days before surgery to the day of surgery
Frequency of preoperative seizure
Number of patients with seizure
Time frame: From 2 days before surgery to the day of surgery
Frequency of postoperative seizure
Number of patients with seizure
Time frame: 1 month
Serum level of S100 beta protein
Serum level of S100 beta protein
Time frame: 2 days after surgery
Serum level of neuron-specific enolase
Serum level of neuron-specific enolase
Time frame: 2 days after surgery
Serum level of Tau-protein
Serum level of Tau-protein
Time frame: 2 days after surgery
Serum level of Neurofilament light polypeptide
Serum level of Neurofilament light polypeptide
Time frame: 2 days after surgery
Serum level of Glial fibrillary acidic protein
Serum level of Glial fibrillary acidic protein
Time frame: 2 days after surgery
This study is terminated, as verified in Sep 2025. You cannot join it, but the record below documents what was studied.
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Negovsky Reanimatology Research Institute