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

Status: Recruiting
Location: See location...
Intervention Type: Other, Drug
Study Type: Interventional
Study Phase: Early Phase 1
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 \[an anti-stress effect of xenon in patients before laser vision correction\].

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 45
Healthy Volunteers: t
View:

• 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.

Locations
Other Locations
Russian Federation
s. Fyodorov Eye Microsurgery Federal State Inctitution
RECRUITING
Krasnodar
Contact Information
Primary
Alexandr Romanov
Saha_ro@mail.ru
+79182942721
Backup
Viktoria Myasnikova
vivlad7@mail.ru
Time Frame
Start Date: 2023-11-01
Estimated Completion Date: 2026-04-01
Participants
Target number of participants: 140
Treatments
Active_comparator: Main group
patients with high anxiety and stress instability who underwent xenon analgosedation before refractive laser vision correction
Other: Control group
patients with high anxiety and stress instability who underwent local anesthesia using standard premedication with hydroxyzine (hydroxyzine) 25 mg.
Related Therapeutic Areas
Sponsors
Leads: The S.N. Fyodorov Eye Microsurgery State Institution

This content was sourced from clinicaltrials.gov