Perioperative Argon Inhalation to Improve Neurocognitive Recovery After Carotid Surgery
NCT ID: NCT07200180
Last Updated: 2025-09-30
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
PHASE3
100 participants
INTERVENTIONAL
2025-10-01
2026-11-01
Brief Summary
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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.
Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
TRIPLE
Study Groups
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Аrgon-oxygen breathing mixture
Perioperative inhalation of an argon-oxygen mixture (70% argon, 30% oxygen)
Аrgon-oxygen breathing mixture
Patients 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
Perioperative inhalation of an nitrogen-oxygen mixture (70% nitrogen, 30% oxygen)
Nitrogen-oxygen breathing mixture
Patients 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
Interventions
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Аrgon-oxygen breathing mixture
Patients 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
Patients 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
Eligibility Criteria
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Inclusion Criteria
* elective carotid artery surgery
* general anesthesia
* written informed consent
Exclusion Criteria
* 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
18 Years
ALL
No
Sponsors
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Negovsky Reanimatology Research Institute
OTHER_GOV
Responsible Party
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Oleg A. Grebenchikov
The head of the laboratory in the Negovsky Reanimatology Research Institute
Principal Investigators
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Oleg Grebenchikov, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Negovsky Reanimatology Research Institute
Locations
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Demikhov Municipal Clinical Hospital 68
Moscow, , Russia
Countries
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Central Contacts
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Facility Contacts
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Viktoriya Antonova, MD, PhD
Role: primary
Other Identifiers
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PAIRS
Identifier Type: -
Identifier Source: org_study_id