A Lithium-Based Medication to Improve Neurological Outcomes After Surgical Carotid Reconstruction
Status:
Not yet recruiting
Trial end date:
2024-11-30
Target enrollment:
Participant gender:
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.
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:
1. To determine if Lithium carbonate is superior to placebo for the occurrence of emergence
delirium, agitation, postoperative delirium and postoperative cognitive dysfunction.
2. 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.