RELIEF OF PSYCHOEMOTIONAL STRESS USING XENON SEDATION

NCT06080100 | Recruiting Early Phase 1

• 1 other identifier: 2
• Study Type: interventional
• Target: 140
• Locations: 1 country
• Sites: 1

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:

1. 1.To develop a method of xenon sedation in patients with a high level of psychoemotional stress before surgery - refractive laser vision correction.
2. 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.

Conditions

Psychological Stress; Anesthesia; Anxiety; Xenon

Keywords

sedation; laser refractive interventions; anxiety; xenon

Outcome Measures

Primary Outcomes (4)

• 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

Study Arms (2)

Main group

ACTIVE COMPARATOR

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

Drug: Xenon

Control group

OTHER

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

Other: premedication hydroxyzine 25 mg

Interventions

Xenon DRUG

inhalation of xenon in a sub-narcotic dosage

Main group

premedication hydroxyzine 25 mg OTHER

taking anxiolytic 30 minutes before surgery

Control group

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• \- concomitant somatic diseases in the decompensation stage.

Sponsors & Collaborators

• The S.N. Fyodorov Eye Microsurgery State Institution: lead

Study Sites (1)

s. Fyodorov Eye Microsurgery Federal State Inctitution

Krasnodar, 350012, Russia

RECRUITING

Related 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.976914

  BACKGROUND

• 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.

  PMID: 25276687 BACKGROUND

• 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.

  PMID: 36977985 BACKGROUND

• 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

  BACKGROUND

• 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.

  PMID: 36042911 BACKGROUND

• 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.

  PMID: 31567264 BACKGROUND

• 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.

  PMID: 29283117 BACKGROUND

• 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.

  PMID: 29768360 BACKGROUND

MeSH Terms

Conditions

Stress, Psychological; Anxiety Disorders

Interventions

Xenon

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior; Mental Disorders

Intervention Hierarchy (Ancestors)

Noble Gases; Elements; Inorganic Chemicals; Gases

Study Officials

• Sergey Sakhnov

  Director

  STUDY DIRECTOR

Central Study Contacts

Alexandr Romanov

CONTACT

+79182942721; Saha_ro@mail.ru

Viktoria Myasnikova

CONTACT

vivlad7@mail.ru

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: anesthesiologist

Model Details: 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.

Study Record Dates

• First Submitted: October 1, 2023
• First Posted: October 12, 2023
• Study Start: November 1, 2023
• Primary Completion: January 1, 2026
• Study Completion: April 1, 2026
• Last Updated: June 27, 2025

Record last verified: 2025-06

Locations

RU (1)