Perioperative Argon Inhalation to Improve Neurocognitive Recovery After Carotid Surgery

Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18+
SponsorNegovsky Reanimatology Research Institute

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 volunteers

Qualifiers

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

Design model

Parallel

Treatments tested in this trial

  • Аrgon-oxygen breathing mixture

    Drug

    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

    Drug

    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

Treatment groups

100 Participants
are divided into 2 treatment groups
Group A: Аrgon-oxygen breathing mixtureExperimental treatment 1 intervention
Group B: Nitrogen-oxygen breathing mixtureSham comparator 1 intervention

Trial outcomes

Primary outcomes

1

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

Time frame
30 days

Secondary outcomes

1

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

Time frame
30 days
2

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)

Time frame
30 days
3

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

Time frame
until 1 month after surgery
4

Incidence of cognitive dysfunction

reduction of ≥1 standard deviation in the Montreal Cognitive Assessment (MoCA) total z-score compared to the preoperative assessment

Time frame
30 days

Other outcomes

Sponsors and contacts

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Negovsky Reanimatology Research Institute

Lead sponsor

GBWZ of Moscow city hospital n.a. S.P. Botkin

Collaborator