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NCT Number: NCT06080100

RELIEF OF PSYCHOEMOTIONAL STRESS USING XENON SEDATION

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].

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Key information

Age range

18 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Early Phase 1

Primary location

s. Fyodorov Eye Microsurgery Federal State Inctitution

Krasnodar, 350012, Russia

Location status: Recruiting

Location contact

Valer'evich Romanov

CONTACT

[email protected]

89182942721

About this study

The aim of the study 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.

Research objectives

  • To develop a method of xenon sedation in patients with a high level of psychoemotional stress before surgery - refractive laser vision correction.
  • 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.
  • To study the dynamics of laboratory stress markers during xenon sedation before refractive laser vision correction operations, in comparison with anxiolytics of the non-benzodiazepine series.
  • To evaluate the change in heart rate variability indicators on the "Varicard" devices and the "Cardiovisor" software package (ECG dispersion mapping method) in comparison with the anxiolytics of the non-benzodiazepine series in the studied groups of patients.
  • To study the economic component in the expenditure of an inhalation anesthetic during xenon anesthesia in a sub-narcotic dosage in outpatient ophthalmic surgery.

The studied phenomena are: 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.

The object of the study:

The main group (patients with high anxiety and stress instability, who underwent xenon analgosedation before refractive laser vision correction) - 70 people.

The control group (patients with high anxiety and stress instability, who underwent local anesthesia using standard premedication with hydroxyzine (hydroxyzine) 25 mg.) - 70 people.

Inclusion criteria

  • upcoming surgery in the form of laser vision correction (Femto Lasik or ReLEx ® SMILE);
  • male and female patients over 18 years of age with high anxiety and stress instability (Spielberger-Khanin test of 46 points or more);
  • signed informed consent to participate in the study.

Non-inclusion criteria:

  • concomitant somatic diseases in the decompensation stage.

Exclusion criteria

  • the patient's desire to withdraw from the study;

Research methods:

  • Assessment of stress levels by testing on the Spielberger-Hanin scale.
  • Examination of the patient on a Cardiovisor and Varicard before and after surgery.
  • Laboratory assessment of the level of capillary glucose and cortisol in the blood before and after surgery.
  • Assessment of postoperative pain on a visual-analog scale.
  • Statistical methods. Practical significance: the use of xenon sedation to relieve the psychoemotional tension of patients during the operation ReLEx® SMILE and Femto Lasik will reduce the frequency of complications of these operations (loss of vacuum fixation). The proposed method will also expand the availability of such operations for patients with increased neuro-reflex excitability.

Novelty of the study:

In this study, for the first time, there will be:

  • The method of application of xenon sedation for relief of psychoemotional tension of patients during operations - refractive laser vision correction (ReLEx® SMILE and Femto Lasik) will be presented.
  • The method of assessing the autonomic nervous system (Varicard) will be used for the first time to control the dynamics of stress in ophthalmic surgery using xenon sedation.
  • The method reflecting changes in the electrophysiological state of the myocardium (Cardiovisor) under the influence of xenon sedation will be used for the first time.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Xenon

Drug

inhalation of xenon in a sub-narcotic dosage

premedication hydroxyzine 25 mg

Other

taking anxiolytic 30 minutes before surgery

Primary outcomes

  1. the concentration of cortisol in the blood

    Time frame: 30 minutes before surgery and 30 minutes after surgery

    the change in the cortisol concentration index as a stress marker during xenon sedation before refractive laser vision correction operations in comparison with anxiolytics of the non-benzodiazepine series.

  2. glucose concentration in capillary blood

    Time frame: 30 minutes before surgery and 30 minutes after surgery

    changes in glucose concentration index as a stress marker during xenon sedation before refractive laser vision correction operations in comparison with anxiolytics of the non-benzodiazepine series.

  3. stress index

    Time frame: 30 minutes before surgery and 30 minutes after surgery

    the change in the heart rate variability measured by the Varikard device in comparison with the anxiolytics of the non-benzodiazepine series in the studied groups of patients.

  4. rhythm index

    Time frame: 30 minutes before surgery and 30 minutes after surgery

    the change in the rhythm index measured by the Cardiovisor device in comparison with benzodiazepine-type anxiolytics in the studied groups of patients.

Study contacts

Contact information is provided by the study sponsor or research team.

Alexandr Romanov

CONTACT

[email protected]

+79182942721

Viktoria Myasnikova

CONTACT

[email protected]

Sponsors and collaborators

Lead sponsor

The S.N. Fyodorov Eye Microsurgery State Institution

Other Gov

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2026
Study completion
2026
First posted
Oct 12, 2023
Registry last updated
Jun 27, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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