Status:
COMPLETED
Sedation and Neuromediators Concentration
Lead Sponsor:
I.M. Sechenov First Moscow State Medical University
Conditions:
Moderate Sedation
Deep Sedation
Eligibility:
All Genders
18-70 years
Phase:
NA
Brief Summary
Propofol (Propofol Kabi, Registration number from the State Register of Medicines - 000875) is a widely used intravenous anesthetic. It is well known about different effects of propofol infusion, incl...
Detailed Description
The study is a prospective, nonrandomized, single center investigator design. Twenty-six healthy patients undergoing elective trauma surgery (arthroscopy, reconstructive foot surgery, osteosynthesis o...
Eligibility Criteria
Inclusion
- Written informed consent
- Age ≥ 18 years
- Elective trauma surgery (arthroscopy, reconstructive foot surgery, osteosynthesis of intra-and periarticular fractures of the proxymal humerus) under regional anesthesia (spinal anesthesia or brachial plexus block) with propofol sedation
- Montreal cognitive assessment test ≥ 26
- Patients with American Society of Anesthesiologists (ASA) I-II
- Non-inclusion criteria:
- Not written informed consent
- Age˂18 years
- Allergy to sedation drugs
- Pregnancy
- Epilepsy anamnesis
- II-III degree atrioventricular block
- Montreal cognitive assessment test ˂ 26
- Patients with American Society of Anesthesiologists (ASA) ˃ II
- The presence of psychiatric disorders
- Сancer patients with a life expectancy of less than two years
Exclusion
- Patient refuse from further participation
- Transition from sedation to general anesthesia
- Allergy on anesthesia drugs during perioperative period
Key Trial Info
Start Date :
October 5 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 15 2021
Estimated Enrollment :
24 Patients enrolled
Trial Details
Trial ID
NCT04695509
Start Date
October 5 2020
End Date
April 15 2021
Last Update
June 10 2021
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
City Clinical Hospital № 31 of the Department of Health of Moscow
Moscow, Russia