RELIEF OF PSYCHOEMOTIONAL STRESS USING XENON SEDATION
Trial statusRecruiting
Trial phaseEarly Phase 1
Trial typeInterventional
Biological sexAll
Age18-45
SponsorThe S.N. Fyodorov Eye Microsurgery State Institution
About this trial
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
This trial accepts healthy volunteersQualifiers
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.
Disqualifiers
None
Trial design
Design model
Parallel
Treatments tested in this trial
Xenon
Druginhalation of xenon in a sub-narcotic dosage
premedication hydroxyzine 25 mg
Other interventiontaking anxiolytic 30 minutes before surgery
Treatment groups
140 Participants
are divided into 2 treatment groupsGroup A: Main groupActive comparator 1 intervention
Group B: Control groupOther 1 intervention
Trial outcomes
Primary outcomes
1
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.
Time frame
30 minutes before surgery and 30 minutes after surgery2
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.
Time frame
30 minutes before surgery and 30 minutes after surgery3
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.
Time frame
30 minutes before surgery and 30 minutes after surgery4
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.
Time frame
30 minutes before surgery and 30 minutes after surgerySponsors and contacts
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Source ClinicalTrials.gov