Using xenon sedation to reduce stress before eye surgery
RELIEF OF PSYCHOEMOTIONAL STRESS BEFORE REFRACTIVE LASER VISION CORRECTION SURGERY USING XENON SEDATION
This study is testing if using xenon sedation can help reduce stress and improve the experience for people getting laser eye surgery compared to regular anxiety medications.
Quick facts
| Phase | Early Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 140 (estimated) |
| Ages | 18 Years to 45 Years |
| Sex | All |
| Sponsor | The S.N. Fyodorov Eye Microsurgery State Institution Government |
| Locations | 1 site (Krasnodar) |
| Trial ID | NCT06080100 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to evaluate the effectiveness of xenon sedation in alleviating psychoemotional stress in patients undergoing refractive laser vision correction. It will develop a method for administering xenon sedation and assess its impact on surgery duration, patient and surgeon satisfaction, and postoperative pain levels compared to traditional anxiolytics. The study will also monitor various physiological stress markers and the economic aspects of using xenon as an anesthetic. Participants will be closely monitored for changes in anxiety levels and heart rate variability during the procedure.
Who should consider this trial
Good fit: Ideal candidates are patients scheduled for ReLEx® SMILE surgery who exhibit high levels of anxiety and stress instability.
Not a fit: Patients with concomitant somatic diseases in the decompensation stage may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly improve the surgical experience for patients with high anxiety, leading to better outcomes and satisfaction.
How similar studies have performed: While the use of xenon sedation is a novel approach, similar studies have shown promising results with alternative sedation methods in high-anxiety surgical patients.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Krasnodar
- s. Fyodorov Eye Microsurgery Federal State Inctitution — Krasnodar, Russia (Recruiting)
Study contacts
- Study coordinator: Alexandr Romanov
- Email: Saha_ro@mail.ru
- Phone: +79182942721
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.