RecruitingEarly Phase 1NCT06080100

RELIEF OF PSYCHOEMOTIONAL STRESS USING XENON SEDATION

RELIEF OF PSYCHOEMOTIONAL STRESS BEFORE REFRACTIVE LASER VISION CORRECTION SURGERY USING XENON SEDATION


Sponsor

The S.N. Fyodorov Eye Microsurgery State Institution

Enrollment

140 participants

Start Date

Nov 1, 2023

Study Type

INTERVENTIONAL

Conditions

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


Eligibility

Min Age: 18 YearsMax Age: 45 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether inhaling xenon gas at low sedative levels can reduce psychological stress and anxiety in patients who are about to undergo ReLEx SMILE — a type of laser eye surgery for vision correction. **You may be eligible if...** - You are scheduled to have ReLEx SMILE laser eye surgery - You have high anxiety or emotional instability (scoring 46 points or more on the Spielberger-Khanin anxiety test) - You have signed informed consent to participate **You may NOT be eligible if...** - You have serious ongoing health conditions that are not well controlled (decompensated somatic diseases) - You do not meet the anxiety score threshold - You have not consented to participate Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGXenon

inhalation of xenon in a sub-narcotic dosage

OTHERpremedication hydroxyzine 25 mg

taking anxiolytic 30 minutes before surgery


Locations(1)

s. Fyodorov Eye Microsurgery Federal State Inctitution

Krasnodar, Russia

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NCT06080100


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