RELIEF OF PSYCHOEMOTIONAL STRESS USING XENON SEDATION

Anxiety Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06080100
• Other study ID #: 2
• Status: Recruiting
• Phase: Early Phase 1
• Start date: November 1, 2023
• Est. completion date: April 1, 2025

Study information

• Verified date: February 2024
• Source: The S.N. Fyodorov Eye Microsurgery State Institution
• Contact: Alexandr Romanov
• Phone: +79182942721
• Email: Saha_ro[@]mail.ru
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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].

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 140
• Est. completion date: April 1, 2025
• Est. primary completion date: December 1, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 45 Years

Eligibility

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.

Related Conditions & MeSH terms

• Anesthesia
• Anxiety
• Psychological Stress
• Stress, Psychological
• Xenon

Intervention

Drug:
• Xenon
inhalation of xenon in a sub-narcotic dosage

Other:
• premedication hydroxyzine 25 mg
taking anxiolytic 30 minutes before surgery

Locations

Country	Name	City	State
Russian Federation	s. Fyodorov Eye Microsurgery Federal State Inctitution	Krasnodar

Sponsors (1)

Lead Sponsor	Collaborator
The S.N. Fyodorov Eye Microsurgery State Institution

Country where clinical trial is conducted

Russian Federation, 

References & Publications (8)

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.97

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. — View 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

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; — View 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. — View 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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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