Actively Recruiting
Perioperative Argon Inhalation to Improve Neurocognitive Recovery After Carotid Surgery (PAIRS Trial)
Led by Negovsky Reanimatology Research Institute · Updated on 2025-12-29
100
Participants Needed
1
Research Sites
4 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating whether inhaling an argon-containing gas mixture during the perioperative period can reduce brain injuries and cognitive problems in patients undergoing carotid endarterectomy (CEA) surgery. This surgery is performed to prevent ischemic strokes caused by significant narrowing of the carotid arteries. Despite successful surgery, patients remain at risk for silent strokes and cognitive decline, which can lead to dementia. There are currently no established drug treatments to prevent these complications, making this study important for improving patient outcomes. The study compares two groups: one inhales a mixture of 70% argon and 30% oxygen, while the other inhales a mixture of 70% nitrogen and 30% oxygen as a control. Each patient receives inhalations lasting 60 minutes on the day before surgery, 60 minutes one hour before going to the operating room, and 60 minutes on the first day after surgery. This approach aims to assess the potential protective effects of argon gas during the surgical period. Participants will be monitored for signs of postoperative delirium and cognitive dysfunction over 30 days after surgery. Researchers will measure various outcomes, including the occurrence and duration of delirium, incidence of both overt and silent strokes, inflammatory markers in the blood, and length of hospital and intensive care stays. The study uses a randomized, triple-blind design to ensure reliable results and will follow patients carefully to assess the impact of the gas mixtures on neurocognitive recovery.
CONDITIONS
Brief Title
Perioperative Argon Inhalation to Improve Neurocognitive Recovery After Carotid Surgery
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age over 18 years
- Scheduled for elective carotid artery surgery
- Planned use of general anesthesia
- Able and willing to provide written informed consent
You will not qualify if you...
- Any mental disorder confirmed by a psychiatrist
- Any neuromuscular disease
- Heart failure classified as New York Heart Association class 3 or 4
- Pregnant or breastfeeding women
- Inability to undergo preoperative assessment
- Previous participation in this trial
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 1 day
Participants receive inhalations with an argon-oxygen or nitrogen-oxygen mixture prior to surgery.
3 inhalation sessions on day 1 prior to surgery and before operating room transfer
Duration - Until hospital discharge
Participants undergo carotid artery surgery with general anesthesia and receive a postoperative inhalation session.
1 postoperative inhalation session and monitoring during hospital stay
Duration - 30 days after surgery
Participants are monitored for neurocognitive recovery and postoperative outcomes including delirium and stroke incidence.
Follow-up visits and assessments during the 30 days after surgery
Trial Site Locations
Total: 1 location
1
Demikhov Municipal Clinical Hospital 68
Moscow, Russia
Actively Recruiting
Research Team
O
Oleg Grebenchikov, MD, PhD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
2
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