Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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:
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].
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
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:
Non-inclusion criteria:
• concomitant somatic diseases in the decompensation stage.
Exclusion criteria:
• the patient's desire to withdraw from the study;
Research methods:
Novelty of the study:
In this study, for the first time, there will be:
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Main group | Active Comparator | patients with high anxiety and stress instability who underwent xenon analgosedation before refractive laser vision correction |
|
| Control group | Other | patients with high anxiety and stress instability who underwent local anesthesia using standard premedication with hydroxyzine (hydroxyzine) 25 mg. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Xenon | Drug | inhalation of xenon in a sub-narcotic dosage |
| |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 30 minutes before surgery and 30 minutes after surgery |
| 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. | 30 minutes before surgery and 30 minutes after surgery |
| 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. | 30 minutes before surgery and 30 minutes after surgery |
| 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. | 30 minutes before surgery and 30 minutes after surgery |
Not provided
Not provided
Inclusion Criteria:
Exclusion Criteria:
- concomitant somatic diseases in the decompensation stage.
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Alexandr Romanov | Contact | +79182942721 | Saha_ro@mail.ru | |
| Viktoria Myasnikova | Contact | vivlad7@mail.ru |
| Name | Affiliation | Role |
|---|---|---|
| Sergey Sakhnov | Director | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| s. Fyodorov Eye Microsurgery Federal State Inctitution | Recruiting | Krasnodar | 350012 | Russia |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| Result | 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 | ||
| 25276687 | Result | 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. | |
| 36977985 |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D013315 | Stress, Psychological |
| D001008 | Anxiety Disorders |
| ID | Term |
|---|---|
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
| D001523 | Mental Disorders |
Not provided
Not provided
| ID | Term |
|---|---|
| D014978 | Xenon |
| ID | Term |
|---|---|
| D005741 | Noble Gases |
| D004602 | Elements |
| D007287 | Inorganic Chemicals |
| D005740 | Gases |
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
| premedication hydroxyzine 25 mg |
| Other |
taking anxiolytic 30 minutes before surgery |
|
| Result |
| 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. |
| Result | 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 |
| 36042911 | Result | 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. |
| 31567264 | Result | 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. |
| 29283117 | Result | 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. |
| 29768360 | Result | 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. |