NCT06080100 RELIEF OF PSYCHOEMOTIONAL STRESS USING XENON SEDATION
| NCT ID | NCT06080100 |
| Status | Recruiting |
| Phase | EARLY_Phase 1 |
| Sponsor | The S.N. Fyodorov Eye Microsurgery State Institution |
| Condition | Psychological Stress |
| Study Type | INTERVENTIONAL |
| Enrollment | 140 participants |
| Start Date | 2023-11-01 |
| Primary Completion | 2026-01-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 140 participants in total. It began in 2023-11-01 with a primary completion date of 2026-01-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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. 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 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.
Contact & Investigator
Sergey Sakhnov
STUDY DIRECTOR
Director
Frequently Asked Questions
Who can join the NCT06080100 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 45 Years, studying Psychological Stress. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06080100 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT06080100 currently recruiting?
Yes, NCT06080100 is actively recruiting participants. Contact the research team at Saha_ro@mail.ru for enrollment information.
Where is the NCT06080100 trial being conducted?
This trial is being conducted at Krasnodar, Russia.
Who is sponsoring the NCT06080100 clinical trial?
NCT06080100 is sponsored by The S.N. Fyodorov Eye Microsurgery State Institution. The principal investigator is Sergey Sakhnov at Director. The trial plans to enroll 140 participants.