Clinical trial NCT06080100: RELIEF OF PSYCHOEMOTIONAL STRESS USING XENON SEDATION
Official title: RELIEF OF PSYCHOEMOTIONAL STRESS BEFORE REFRACTIVE LASER VISION CORRECTION SURGERY USING XENON SEDATION
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: EARLY_PHASE1
Conditions: Psychological Stress
Anesthesia
Anxiety
Xenon
Keywords: sedation
laser refractive interventions
anxiety
xenon
Lead sponsor: The S.N. Fyodorov Eye Microsurgery State Institution
Sponsor class: OTHER_GOV
First posted: 2023-10-12
Enrollment: 140
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: TREATMENT

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

Detailed description: 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

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.
3. 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.
4. 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.
5. 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:

1. Assessment of stress levels by testing on the Spielberger-Hanin scale.
2. Examination of the patient on a Cardiovisor and Varicard before and after surgery.
3. Laboratory assessment of the level of capillary glucose and cortisol in the blood before and after surgery.
4. Assessment of postoperative pain on a visual-analog scale.
5. 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:

1. 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.
2. 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.
3. 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.

Eligibility criteria: 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.

Primary outcomes:
measure: the concentration of cortisol in the blood
timeFrame: 30 minutes before surgery and 30 minutes after surgery
measure: glucose concentration in capillary blood
timeFrame: 30 minutes before surgery and 30 minutes after surgery
measure: stress index
timeFrame: 30 minutes before surgery and 30 minutes after surgery
measure: rhythm index
timeFrame: 30 minutes before surgery and 30 minutes after surgery
Secondary outcomes:
Other outcomes:
Locations:
city: Krasnodar
country: Russian Federation
facility: s. Fyodorov Eye Microsurgery Federal State Inctitution
Study officials:
affiliation: Director
name: Sergey Sakhnov
role: STUDY_DIRECTOR
References:
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