s. Fyodorov Eye Microsurgery Federal State Inctitution
Krasnodar, 350012, Russia
Location status: Recruiting
NCT Number: NCT06080100
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].
Interested in participating?
Request Info18 year–45 year
All sexes
Interventional
Early Phase 1
Krasnodar, 350012, Russia
Location status: Recruiting
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
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
Non-inclusion criteria:
Exclusion criteria
Research methods:
Novelty of the study:
In this study, for the first time, there will be:
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
inhalation of xenon in a sub-narcotic dosage
taking anxiolytic 30 minutes before surgery
Time frame: 30 minutes before surgery and 30 minutes after surgery
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.
Time frame: 30 minutes before surgery and 30 minutes after surgery
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.
Time frame: 30 minutes before surgery and 30 minutes after surgery
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.
Time frame: 30 minutes before surgery and 30 minutes after surgery
the change in the rhythm index measured by the Cardiovisor device in comparison with benzodiazepine-type anxiolytics in the studied groups of patients.
Contact information is provided by the study sponsor or research team.
Alexandr Romanov
CONTACT
Viktoria Myasnikova
CONTACT
The S.N. Fyodorov Eye Microsurgery State Institution
Other Gov
RELIEF OF PSYCHOEMOTIONAL STRESS BEFORE REFRACTIVE LASER VISION CORRECTION SURGERY USING XENON SEDATION
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