Perioperative Argon Inhalation to Improve Neurocognitive Recovery After Carotid Surgery

Recruiting now · Phase 3

Conditions studied: Carotid Artery Disease, Carotid Artery Stenoses

In brief

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.

Key facts

Study ID: NCT07200180
Run by: Negovsky Reanimatology Research Institute
People needed: 100
Starts: 2025-09-22
Expected to finish: 2026-11-01
Last updated by the study team: 2026-06-18

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

age > 18 years
elective carotid artery surgery
general anesthesia
written informed consent

You may not qualify if…

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
Inability to undergo a preoperative assessment for any reason
Previously enrolled in this trial

Where it is running

GBWZ of Moscow city hospital n.a. S.P. Botkin — Moscow, Russia (enrolling)
Demikhov Municipal Clinical Hospital 68 — Moscow, Russia (enrolling)

Full record on ClinicalTrials.gov

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