Clinical Trial

RELIEF OF PSYCHOEMOTIONAL STRESS USING XENON SEDATION

Recruiting Early Phase 1
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Record status
This record was last updated June 27, 2025 (before its estimated January 1, 2026 completion). Its status may not reflect the trial's current state.
Summary
The goal of this clinical trial is to propose for implementation and evaluate the effectiveness of xenon sedation for the relief of psychoemotional stress disorder before the operation of refractive laser vision correction patients with high anxiety and stress instability who underwent xenon analgosedation before refractive laser vision correction. The main question\[s\] it aims to answer are: 1. To develop a method of xenon sedation in patients with a high level of psychoemotional stress before surgery - refractive laser vision correction. 2. To evaluate the effect of inhaled xenon anesthesia in a sub-narcotic dose on the duration of surgery, satisfaction of surgeons and patients with anesthesia, the level of postoperative pain in patients in comparison with anxiolytics. The following will be studied: the level of preoperative anxiety, the dynamics of glycemia and blood cortisol levels, heart rate variability, electrical microamplitudes of the ECG signal, the anti-stress and analgesic effect of xenon. If there is a comparison group: the researchers will compare \[the group with xenon sedation and the control group\] to see if there is \[an anti-stress effect of xenon in patients before laser vision correction\].
Protocol Amendment History 2 amendments
This ClinicalTrials.gov record has been amended 2 times since 2023-10-05; most recent amendment 2025-06-24.
Status change: Not Yet Recruiting → Recruiting 2024-02-13
Trial Details
NCT Number NCT06080100
Lead Sponsor The S.N. Fyodorov Eye Microsurgery State Institution
Conditions Psychological Stress, Anesthesia, Anxiety, Xenon
Enrollment 140 participants
Start Date 2023-11-01
Primary Completion 2026-01-01 (estimated)
Study Completion 2026-04-01 (estimated)
Updated on ClinicalTrials.gov 2025-06-27