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Clinical Trials/NCT06080100
NCT06080100
Recruiting
Early Phase 1

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

The S.N. Fyodorov Eye Microsurgery State Institution1 site in 1 country140 target enrollmentNovember 1, 2023

Overview

Phase
Early Phase 1
Intervention
Xenon
Conditions
Psychological Stress
Sponsor
The S.N. Fyodorov Eye Microsurgery State Institution
Enrollment
140
Locations
1
Primary Endpoint
glucose concentration in capillary blood
Status
Recruiting
Last Updated
10 months ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
November 1, 2023
End Date
April 1, 2026
Last Updated
10 months ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
The S.N. Fyodorov Eye Microsurgery State Institution
Responsible Party
Principal Investigator
Principal Investigator

Alexander Romanov

anesthesiologist

The S.N. Fyodorov Eye Microsurgery State Institution

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.

Arms & Interventions

Main group

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

Intervention: Xenon

Control group

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

Intervention: premedication hydroxyzine 25 mg

Outcomes

Primary Outcomes

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.

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.

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.

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 Sites (1)

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