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

Study Overview
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Brief Summary
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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: 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. 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].

Detailed Description
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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.

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

Conditions
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Psychological Stress, Anesthesia, Anxiety, Xenon

Intervention / Treatment
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* Drug: Xenon
* Other: premedication hydroxyzine 25 mg


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: According to the latest data, the need for xenon analgosedation occurs in 10% of cases from all excimer laser operations. N= 1,96*10*90/25=70.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Main group<br>patients with high anxiety and stress instability who underwent xenon analgosedation before refractive laser vision correction | Drug: Xenon<br>* inhalation of xenon in a sub-narcotic dosage<br>|
| Other: Control group<br>patients with high anxiety and stress instability who underwent local anesthesia using standard premedication with hydroxyzine (hydroxyzine) 25 mg. | Other: premedication hydroxyzine 25 mg<br>* taking anxiolytic 30 minutes before surgery<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| the concentration of cortisol in the blood | 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. | 30 minutes before surgery and 30 minutes after surgery | 
| glucose concentration in capillary blood | 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. | 30 minutes before surgery and 30 minutes after surgery | 
| stress index | 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. | 30 minutes before surgery and 30 minutes after surgery | 
| rhythm index | the change in the rhythm index measured by the Cardiovisor device in comparison with benzodiazepine-type anxiolytics in the studied groups of patients. | 30 minutes before surgery and 30 minutes after surgery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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sedation, laser refractive interventions, anxiety, xenon