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RELIEF OF PSYCHOEMOTIONAL STRESS USING XENON SEDATION

NCT06080100 · Status: RECRUITING · Phase: EARLY_PHASE1 · Type: INTERVENTIONAL · Enrollment: 140

Last updated 2025-06-27

No results posted yet for this study

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

Conditions

  • Psychological Stress
  • Anesthesia
  • Anxiety
  • Xenon

Interventions

DRUG

Xenon

inhalation of xenon in a sub-narcotic dosage

OTHER

premedication hydroxyzine 25 mg

taking anxiolytic 30 minutes before surgery

Sponsors & Collaborators

  • The S.N. Fyodorov Eye Microsurgery State Institution

    lead OTHER_GOV

Principal Investigators

  • Sergey Sakhnov · Director

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2023-11-01
Primary Completion
2026-01-01
Completion
2026-04-01

Countries

  • Russia

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06080100 on ClinicalTrials.gov