RELIEF OF PSYCHOEMOTIONAL STRESS USING XENON SEDATION

• Status: Recruiting
• Trial end date: 2025-04-01
• Target enrollment: 0
• Participant gender: All

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].

• Phase: Early Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: The S.N. Fyodorov Eye Microsurgery State Institution
• Treatments: Hydroxyzine

Criteria

Inclusion Criteria:

• upcoming operation ReLEx® SMILE;

• high anxiety and stress instability (Spielberger-Khanin test of 46 points or more);

• signed informed consent to participate in the study.

Exclusion Criteria:

• concomitant somatic diseases in the decompensation stage.