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
About this trial
This is an interventional treatment trial for Psychological Stress focused on measuring sedation, laser refractive interventions, anxiety, xenon
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.
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
NCT ID
NCT06080100
First Posted
October 1, 2023
Last Updated
October 5, 2023
Sponsor
The S.N. Fyodorov Eye Microsurgery State Institution
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
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RELIEF OF PSYCHOEMOTIONAL STRESS BEFORE REFRACTIVE LASER VISION CORRECTION SURGERY USING XENON SEDATION
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