About this trial
Currently, over 400,000 reconstructive surgeries on carotid arteries are performed annually worldwide, including carotid endarterectomy (CEA) and carotid stenting. These interventions have proven effective in preventing ischemic stroke in patients with hemodynamically significant carotid artery stenoses. However, even following a technically successful procedure, the risk of perioperative ischemic brain injury persists. According to meta-analyses, one in five patients exhibits covert ("silent") strokes after reconstructive interventions, with their frequency being ten times higher than that of clinically manifest events. Such lesions are associated with cognitive decline and an increased risk of dementia. An additional risk factor is the "no-reflow" phenomenon-an impairment of microcirculatory reperfusion that occurs even after the restoration of macrovascular blood flow, thereby limiting the effectiveness of surgical revascularization.
Cognitive disorders and postoperative delirium, observed in 15-30% of patients after CEA, adversely affect rehabilitation and long-term prognosis. To date, there are no reliable pharmacological strategies to prevent these complications.
In this context, inert gases have attracted significant interest as potential neuroprotective agents. Xenon, despite its proven efficacy, is limited by high cost and challenges in industrial production. Argon, in contrast, is accessible, safe, and technologically straightforward to administer. In preclinical models of stroke and ischemia-reperfusion, argon has demonstrated pronounced anti-apoptotic, anti-inflammatory, and antioxidant effects, mediated through the regulation of TLR2/4-, ERK1/2-, Nrf2-, and NF-κB-dependent signaling pathways. Its ability to suppress microglial activation towards the M1 phenotype and inhibit the NLRP3 inflammasome has been noted, which reduces neuroinflammation and decreases the volume of secondary neuronal damage. Short-term argon inhalation in healthy volunteers has shown a favorable safety profile with no adverse effects on cerebral hemodynamics.
Thus, it is highly relevant to clinically test the hypothesis that perioperative inhalation of an argon-containing gas mixture can reduce the incidence of ischemic brain injuries and cognitive impairments in patients undergoing CEA.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
age > 18 years
elective carotid artery surgery
general anesthesia
written informed consent
Disqualifiers
The presence of any mental disorder according to the International Classification of Diseases 10th Revision which is confirmed by a psychiatrist.
The presence of any neuromuscular disease according to the International Classification of Diseases 10th Revision
Heart failure equal 3 or 4 class according to the New York Heart Association Functional Classification
Pregnant or breast-feeding women
Trial design
Parallel
Treatments tested in this trial
Аrgon-oxygen breathing mixture
DrugPatients receive a course of inhalations with an argon-oxygen mixture according to the following protocol: 60 minutes on day 1 prior to surgery, 60 minutes one hour before being transferred to the operating room, and 60 minutes on the first postoperative day
Nitrogen-oxygen breathing mixture
DrugPatients receive a course of inhalations with an nitrogen-oxygen mixture according to the following protocol: 60 minutes on day 1 prior to surgery, 60 minutes one hour before being transferred to the operating room, and 60 minutes on the first postoperative day
Treatment groups
Trial outcomes
Primary outcomes
Incidence of postoperative delirium
Number of patients with even one positive confusion assessment method for the intensive care unit or 3-minute confusion assessment method
Secondary outcomes
Incidence 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
Incidence of postoperative 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)
Duration 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
Incidence of cognitive dysfunction
reduction of ≥1 standard deviation in the Montreal Cognitive Assessment (MoCA) total z-score compared to the preoperative assessment
Sponsors and contacts
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Negovsky Reanimatology Research Institute
Lead sponsor
GBWZ of Moscow city hospital n.a. S.P. Botkin
Collaborator