Effect General and Regional Anesthesia on Glycocalyx
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 60
- Primary Endpoint
- Change in Perfused Boundary Region (PBR)
Study Overview
Brief Summary
Observational study evaluating effect general or regional anaesthesia on glycocalyx by using perfused Boundary Region in sublingual microcirculation.
Detailed Description
Study II: Effect general and regional anaesthesia on GCX Hypothesis to be tested: Regional anaesthesia affects GCX less than general anaesthesia.
The aim of the study: Comparison of two anaesthesia techniques with respect to GCX.
Type of the study: Observational. Subjects: Adult patients ASA 2-3 undergoing elective total knee replacement surgery under general or regional anaesthesia. Sample size calculation (based on expected difference in PRB, alpha error I = 0,05 and study power = 0,99) = 52 patients. Investigators plan to enroll of 60 consecutive patients to reach 30 patients with each type of anaesthesia. Intervention: none. Data to be recorded and analysed: Demographics, ASA, physiologic functions (during surgery and 24 hours after surgery), fluids given, sublingual microcirculation by SDF imaging will be recorded at time points: before anaesthesia, 24 hours after anaesthesia, clinical outcome indicators, microcirculatory data and Perfused Boundary Region.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Adult patients ASA 2-3 undergoing elective total knee replacement surgery
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
Change in Perfused Boundary Region (PBR)
Time Frame: Change from baseline PBR at 24 hours after surgery
PBR is an indirect measure of glycocalyx thickness
Secondary Outcomes
No secondary outcomes reported
Investigators
Vladimir Cerny
prof. Vladimir Cerny, MD, PhD, FCCM
University Hospital Hradec Kralove