A Lithium-Based Medication to Improve Neurological Outcomes After Surgical Carotid Reconstruction

Launched by NEGOVSKY REANIMATOLOGY RESEARCH INSTITUTE · Nov 8, 2021

Keywords

ClinConnect Summary

This clinical trial is studying whether a lithium-based medication can help improve brain health after carotid artery surgery. Carotid artery surgery is often needed to treat serious blockages that can lead to strokes, but during the surgery, there is a temporary loss of blood flow to the brain, which can cause problems like confusion or memory issues after the procedure. Researchers want to find out if taking lithium carbonate before the surgery can reduce these risks and improve recovery.

To join the trial, participants must be at least 18 years old and scheduled for elective carotid artery surgery under general anesthesia. They need to give their written consent to participate. However, people with recent strokes, certain mental health conditions, or specific heart and kidney issues will not be eligible. Those who participate will be randomly assigned to receive either the lithium medication or a placebo (a non-active treatment) to see how well it works. This trial is still recruiting participants, and it aims to determine if lithium can help patients avoid some of the common complications after surgery.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • age \> 18 years
• • elective carotid artery surgery
• • general anesthesia
• • written informed consent
• Exclusion Criteria:
• • 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