Ignite Creation Date:
2024-05-06 @ 7:39 PM
Last Modification Date:
2024-10-26 @ 3:10 PM
Study NCT ID:
NCT06080100
Status:
RECRUITING
Last Update Posted:
2024-02-14
First Post:
2023-10-01
Brief Title:
RELIEF OF PSYCHOEMOTIONAL STRESS USING XENON SEDATION
Sponsor:
The SN Fyodorov Eye Microsurgery State Institution
Organization:
The SN Fyodorov Eye Microsurgery State Institution
Study Overview
Official Title:
RELIEF OF PSYCHOEMOTIONAL STRESS BEFORE REFRACTIVE LASER VISION CORRECTION SURGERY USING XENON SEDATION
Status:
RECRUITING
Status Verified Date:
2024-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 questions 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
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 patients 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
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 patients 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None