Anesthesia, Glycocalyx, Perfused Boundary Region
Conditions
Keywords
Anesthesia, glycocalyx, perfused boundary region
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.
Interventions
OTHERGeneral anesthesia
General anesthesia
OTHERRegional anesthesia
Regional anesthesia
Sponsors
University Hospital Hradec Kralove
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Adult patients ASA 2-3 undergoing elective total knee replacement surgery
Exclusion criteria
None
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Perfused Boundary Region (PBR) | Change from baseline PBR at 24 hours after surgery | PBR is an indirect measure of glycocalyx thickness |
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| General Anesthesia Adult patients ASA 2-3 undergoing elective total knee replacement surgery under general anaesthesia.
General anesthesia: General anesthesia | 30 |
| Regional Anesthesia Adult patients ASA 2-3 undergoing elective total knee replacement surgery under regional anaesthesia.
Regional anesthesia: Regional anesthesia | 30 |
| Total | 60 |
Baseline characteristics
| Characteristic | General Anesthesia | Regional Anesthesia | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 10 Participants | 10 Participants | 20 Participants |
| Age, Categorical Between 18 and 65 years | 20 Participants | 20 Participants | 40 Participants |
| Age, Continuous | 66 years STANDARD_DEVIATION 7 | 67 years STANDARD_DEVIATION 9 | 66 years STANDARD_DEVIATION 8 |
| Baseline PBR | 2.02 micrometer STANDARD_DEVIATION 0.26 | 1.95 micrometer STANDARD_DEVIATION 0.24 | 1.99 micrometer STANDARD_DEVIATION 0.25 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 30 Participants | 30 Participants | 60 Participants |
| Region of Enrollment Czechia | 30 participants | 30 participants | 60 participants |
| Sex: Female, Male Female | 16 Participants | 14 Participants | 30 Participants |
| Sex: Female, Male Male | 14 Participants | 16 Participants | 30 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 30 | 0 / 30 |
| other Total, other adverse events | 12 / 30 | 1 / 30 |
| serious Total, serious adverse events | 12 / 30 | 1 / 30 |
Outcome results
Primary
Change in Perfused Boundary Region (PBR)
PBR is an indirect measure of glycocalyx thickness
Time frame: Change from baseline PBR at 24 hours after surgery
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| General Anesthesia | Change in Perfused Boundary Region (PBR) | 2.20 micrometer | Standard Deviation 0.25 |
| Regional Anesthesia | Change in Perfused Boundary Region (PBR) | 2.09 micrometer | Standard Deviation 0.19 |