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NCT07200180RecruitingPhase 3

Perioperative Argon Inhalation to Improve Neurocognitive Recovery After Carotid Surgery

Perioperative Argon Inhalation to Improve Neurocognitive Recovery After Carotid Surgery (PAIRS Trial)

Source: ClinicalTrials.gov · Last updated 18 Jun 2026

Brief summary (registry, in English)

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.

Status (registry)
Recruiting
Phase (registry)
Phase 3
Study type
Interventional
Enrollment
100 (estimated)
First submitted
22 Sept 2025
Start date
22 Sept 2025
Primary completion date
1 Oct 2026
Lead sponsor
Negovsky Reanimatology Research Institute
Diseases
Stroke
NCT number
NCT07200180

What you commit to

  • Study type: Interventional · Phase 3
  • Planned participants: 100
  • From 22 Sept 2025 to the primary completion date, 1 Oct 2026
  • 2 sites in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Previously enrolled in this trial

Other illness

  • 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

Other

  • Pregnant or breast-feeding women
  • Inability to undergo a preoperative assessment for any reason

Who the study is looking for

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

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (2)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
GBWZ of Moscow city hospital n.a. S.P. Botkin
Coordinator of this site? Confirm its status
MoscowRussiaRecruiting
Demikhov Municipal Clinical Hospital 68
Coordinator of this site? Confirm its status
MoscowRussiaRecruiting

This page is information, not medical advice. Discuss any trial with your doctor.