RELIEF OF PSYCHOEMOTIONAL STRESS USING XENON SEDATION

The S.N. Fyodorov Eye Microsurgery State Institution

Status and phase: Enrolling; Early Phase 1

Conditions: Psychological Stress; Anxiety; Xenon; Anesthesia

Treatments: Drug: Xenon; Other: premedication hydroxyzine 25 mg

Study type: Interventional

Funder types: Other

Identifiers

NCT06080100

2

Details and patient eligibility

About

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].

Full 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.

Enrollment: 140 estimated patients

Sex: All

Ages: 18 to 45 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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140 participants in 2 patient groups

Main group

Active Comparator group

Description:

patients with high anxiety and stress instability who underwent xenon analgosedation before refractive laser vision correction

Treatment:

Drug: Xenon

Control group

Other group

Description:

patients with high anxiety and stress instability who underwent local anesthesia using standard premedication with hydroxyzine (hydroxyzine) 25 mg.

Treatment:

Other: premedication hydroxyzine 25 mg