Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Observational study evaluating effect general or regional anaesthesia on glycocalyx by using perfused Boundary Region in sublingual microcirculation.
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| General anesthesia | Adult patients ASA 2-3 undergoing elective total knee replacement surgery under general anaesthesia. |
| |
| Regional anesthesia | Adult patients ASA 2-3 undergoing elective total knee replacement surgery under regional anaesthesia. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| General anesthesia | Other | General anesthesia |
| |
| Regional anesthesia |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Perfused Boundary Region (PBR) | PBR is an indirect measure of glycocalyx thickness | Change from baseline PBR at 24 hours after surgery |
Not provided
Not provided
Inclusion Criteria:
Adult patients ASA 2-3 undergoing elective total knee replacement surgery
Exclusion Criteria:
None
Not provided
Not provided
Not provided
Adult patients ASA 2-3 undergoing elective total knee replacement surgery
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Vladimir Cerny, MD | University Hospital Hradec Kralova, Czech Republic | Principal Investigator |
Not provided
On request if privacy guaranteed
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | General Anesthesia | Adult patients ASA 2-3 undergoing elective total knee replacement surgery under general anaesthesia. General anesthesia: General anesthesia |
| FG001 | Regional Anesthesia | Adult patients ASA 2-3 undergoing elective total knee replacement surgery under regional anaesthesia. Regional anesthesia: Regional anesthesia |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | General Anesthesia | Adult patients ASA 2-3 undergoing elective total knee replacement surgery under general anaesthesia. General anesthesia: General anesthesia |
| BG001 | Regional Anesthesia |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Change in Perfused Boundary Region (PBR) | PBR is an indirect measure of glycocalyx thickness | Posted | Mean | Standard Deviation | micrometer | Change from baseline PBR at 24 hours after surgery |
|
1 year
A serious adverse event represents a situation that required patient transport to the ICU or prolongation of stay in the hospital. The other adverse event represents a situation in which a doctor had been called but with no impact on patient stay or short-term outcome.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | General Anesthesia | Adult patients ASA 2-3 undergoing elective total knee replacement surgery under general anaesthesia. General anesthesia: General anesthesia |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| PONV | Gastrointestinal disorders | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| pain | Nervous system disorders | Systematic Assessment |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. David Astapenko | University Hospital Hradec Kralove | +420608177374 | astapenko.d@seznam.cz |
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Nov 7, 2019 | Nov 8, 2019 | Prot_SAP_000.pdf |
Not provided
| ID | Term |
|---|---|
| D000768 | Anesthesia, General |
| D000765 | Anesthesia, Conduction |
| ID | Term |
|---|---|
| D000758 | Anesthesia |
| D000760 | Anesthesia and Analgesia |
Not provided
Not provided
Not provided
Not provided
Not provided
| Other |
Regional anesthesia |
|
Adult patients ASA 2-3 undergoing elective total knee replacement surgery under regional anaesthesia.
Regional anesthesia: Regional anesthesia
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Baseline PBR | PBR is perfused boundary region of the sublingual microcirculation as an indirect assessment of the endothelial glycocalyx thickness. | Mean | Standard Deviation | micrometer |
|
| Units | Counts |
|---|---|
| Participants |
|
|
| 0 |
| 30 |
| 12 |
| 30 |
| 12 |
| 30 |
| EG001 | Regional Anesthesia | Adult patients ASA 2-3 undergoing elective total knee replacement surgery under regional anaesthesia. Regional anesthesia: Regional anesthesia | 0 | 30 | 1 | 30 | 1 | 30 |
| anemia | Blood and lymphatic system disorders | Systematic Assessment |
|
| obstipation | Gastrointestinal disorders | Systematic Assessment |
|
| delirium | Nervous system disorders | Systematic Assessment |
|
Not provided
Not provided
Not provided