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

Primary Purpose

Psychological Stress, Anesthesia, Anxiety

Status
Not yet recruiting
Phase
Early Phase 1
Locations
Study Type
Interventional
Intervention
Xenon
premedication hydroxyzine 25 mg
Sponsored by
The S.N. Fyodorov Eye Microsurgery State Institution
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Psychological Stress focused on measuring sedation, laser refractive interventions, anxiety, xenon

Eligibility Criteria

18 Years - 45 Years (Adult)All SexesAccepts 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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Other

    Arm Label

    Main group

    Control group

    Arm Description

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

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

    Outcomes

    Primary Outcome Measures

    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.
    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.
    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.
    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.

    Secondary Outcome Measures

    Full Information

    First Posted
    October 1, 2023
    Last Updated
    October 5, 2023
    Sponsor
    The S.N. Fyodorov Eye Microsurgery State Institution
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    1. Study Identification

    Unique Protocol Identification Number
    NCT06080100
    Brief Title
    RELIEF OF PSYCHOEMOTIONAL STRESS BEFORE REFRACTIVE LASER VISION CORRECTION SURGERY USING XENON SEDATION
    Official Title
    RELIEF OF PSYCHOEMOTIONAL STRESS BEFORE REFRACTIVE LASER VISION CORRECTION SURGERY USING XENON SEDATION
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    October 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    November 1, 2023 (Anticipated)
    Primary Completion Date
    December 1, 2024 (Anticipated)
    Study Completion Date
    April 1, 2025 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    The S.N. Fyodorov Eye Microsurgery State Institution

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Product Manufactured in and Exported from the U.S.
    No
    Data Monitoring Committee
    No

    5. Study Description

    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: 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
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Psychological Stress, Anesthesia, Anxiety, Xenon
    Keywords
    sedation, laser refractive interventions, anxiety, xenon

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Early Phase 1
    Interventional Study Model
    Parallel Assignment
    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)
    Allocation
    Randomized
    Enrollment
    140 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Main group
    Arm Type
    Active Comparator
    Arm Description
    patients with high anxiety and stress instability who underwent xenon analgosedation before refractive laser vision correction
    Arm Title
    Control group
    Arm Type
    Other
    Arm Description
    patients with high anxiety and stress instability who underwent local anesthesia using standard premedication with hydroxyzine (hydroxyzine) 25 mg.
    Intervention Type
    Drug
    Intervention Name(s)
    Xenon
    Intervention Description
    inhalation of xenon in a sub-narcotic dosage
    Intervention Type
    Other
    Intervention Name(s)
    premedication hydroxyzine 25 mg
    Intervention Description
    taking anxiolytic 30 minutes before surgery
    Primary Outcome Measure Information:
    Title
    the concentration of cortisol in the blood
    Description
    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.
    Time Frame
    30 minutes before surgery and 30 minutes after surgery
    Title
    glucose concentration in capillary blood
    Description
    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.
    Time Frame
    30 minutes before surgery and 30 minutes after surgery
    Title
    stress index
    Description
    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.
    Time Frame
    30 minutes before surgery and 30 minutes after surgery
    Title
    rhythm index
    Description
    the change in the rhythm index measured by the Cardiovisor device in comparison with benzodiazepine-type anxiolytics in the studied groups of patients.
    Time Frame
    30 minutes before surgery and 30 minutes after surgery

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    45 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    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.
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Alexandr Romanov
    Phone
    +79182942721
    Email
    Saha_ro@mail.ru
    First Name & Middle Initial & Last Name or Official Title & Degree
    Viktoria Myasnikova
    Email
    vivlad7@mail.ru
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Sergey Sakhnov
    Organizational Affiliation
    Director
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Plan to Share IPD
    Undecided
    Citations:
    Citation
    Duygu Yalinbas, Erman Bozali, Ayla Uzun Çiçek. Comparison of Self-Esteem and Social Anxiety Levels of Adolescents Who Wear Spectacles and Who Do Not. Turkish Journal of Family Medicine & Primary Care.2021; 15(4):862-871. https://doi.org/10.21763/tjfmpc.976914
    Results Reference
    result
    PubMed Identifier
    25276687
    Citation
    Nazari R, Ahmadzadeh R, Mohammadi S, Rafiei Kiasari J. Effects of hand massage on anxiety in patients undergoing ophthalmology surgery using local anesthesia. J Caring Sci. 2012 Aug 25;1(3):129-34. doi: 10.5681/jcs.2012.019. eCollection 2012 Sep.
    Results Reference
    result
    PubMed Identifier
    36977985
    Citation
    Hou H, Li X, Song Y, Ji Y, Sun M, Wang D, Jiao J, Qu J, Gu H. Effect of interactive, multimedia-based home-initiated education on preoperative anxiety inchildren and their parents: a single-center randomized controlled trial. BMC Anesthesiol. 2023 Mar 28;23(1):95. doi: 10.1186/s12871-023-02055-7.
    Results Reference
    result
    Citation
    Hatam Boustani, Sirus Pakseresht, Mitra Zamani, Mohammad Akmali. The effect of music therapy on the anxiety level of patients undergoing LASIK eye surgery before operation. Minerva Medica. 2018. 5(7): 80-87. https://doi.org/10.23736/S0394-9508.17.04756-8
    Results Reference
    result
    PubMed Identifier
    36042911
    Citation
    Sasajima H, Zako M, Ueta Y, Murotani K. Effects of Low-Concentration Nitrous Oxide Anesthesia on Patient Anxiety During Cataract Surgery: A Retrospective Cohort Study. Clin Ophthalmol. 2022 Aug 24;16:2803-2812. doi: 10.2147/OPTH.S382476. eCollection 2022.
    Results Reference
    result
    PubMed Identifier
    31567264
    Citation
    Shah R. History and Results; Indications and Contraindications of SMILE Compared With LASIK. Asia Pac J Ophthalmol (Phila). 2019 Sep-Oct;8(5):371-376. doi: 10.1097/01.APO.0000580132.98159.fa.
    Results Reference
    result
    PubMed Identifier
    29283117
    Citation
    Ganesh S, Brar S, Arra RR. Refractive lenticule extraction small incision lenticule extraction: A new refractive surgery paradigm. Indian J Ophthalmol. 2018 Jan;66(1):10-19. doi: 10.4103/ijo.IJO_761_17.
    Results Reference
    result
    PubMed Identifier
    29768360
    Citation
    Xia Y, Fang H, Xu J, Jia C, Tao G, Yu B. Clinical efficacy of xenon versus propofol: A systematic review and meta-analysis. Medicine (Baltimore). 2018 May;97(20):e10758. doi: 10.1097/MD.0000000000010758.
    Results Reference
    result

    Learn more about this trial

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

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