Actively Recruiting

Early Phase 1
Age: 18Years - 45Years
All Genders
Healthy Volunteers
NCT06080100

RELIEF OF PSYCHOEMOTIONAL STRESS USING XENON SEDATION

Led by The S.N. Fyodorov Eye Microsurgery State Institution · Updated on 2025-06-27

140

Participants Needed

1

Research Sites

126 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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 \[an anti-stress effect of xenon in patients before laser vision correction\].

CONDITIONS

Official Title

RELIEF OF PSYCHOEMOTIONAL STRESS USING XENON SEDATION

Who Can Participate

Age: 18Years - 45Years
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Upcoming operation ReLEx4 SMILE
  • High anxiety and stress instability with a Spielberger-Khanin test score of 46 points or more
  • Signed informed consent to participate in the study
Not Eligible

You will not qualify if you...

  • Concomitant somatic diseases in the decompensation stage

AI-Screening

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Trial Site Locations

Total: 1 location

1

s. Fyodorov Eye Microsurgery Federal State Inctitution

Krasnodar, Russia, 350012

Actively Recruiting

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Research Team

A

Alexandr Romanov

CONTACT

V

Viktoria Myasnikova

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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RELIEF OF PSYCHOEMOTIONAL STRESS USING XENON SEDATION | DecenTrialz