Primary Gonarthrosis
Conditions
Brief summary
This study was planned to investigate the physiopathology of bradycardia and hypotension that occur in some patients with total knee arthroplasty (TKA) between the ages of 65 and 90 years when the tourniquet, which is routinely used in patients with total knee arthroplasty (TKA), is opened at the end of the operation and to determine the physiopathology of these effects of the tourniquet and how these effects can be prevented.
Detailed description
This study was planned to investigate the effects of lower extremity tourniquets routinely used in TDP surgeries on hemodynamics, SpO2, ETCO2 and blood tables in male and female patients aged 65-90 years. In the patients included in the study, measurements from the monitor will be recorded and preop and postop hemogram, complete biochemistry, coagulation arterial blood gases will be recorded from each patient's file and the values before and after the tourniquet will be compared. New randomized prospective studies will be proposed by determining the physiopathological changes (reperfusion syndrome) that occur after opening the tourniquet in patients and evaluating how these changes can be prevented
Interventions
PROCEDURETotal knee replacement
* Is a surgical procedure to resurface a knee damaged by arthritis. Metal and plastic parts are used to cap the ends of the bones that form the knee joint, along with the kneecap. * In the surgical procedure of these surgeries, cement is used to fix the prosthesis.
Sponsors
Saglik Bilimleri Universitesi Gazi Yasargil Training and Research Hospital
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
65 Years to 90 Years
Healthy volunteers
No
Inclusion criteria
* ASA score: 1-3 * primary gonarthrosis
Exclusion criteria
* ASA score 4 and above * The diagnosis of secondary gonarthrosis * Concomitant rheumatological disorders * Concomitant peripheral vascular disease * Concomitant malignant disease * Presence of organ failure * Having active infection * Use of immunosuppressive drugs * Having addiction to cigarettes, alcohol or drugs * Use of anticoagulation medicine * Presence of metabolic disease * Presence of renal disease * Presence of familial hemophagocytic syndrome * Being unwilling to participate the study
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Activated Partial Thromboplastin Time(APTT) | Time 1:Preoperative 24th hour, Time 2: Approximately 10-15 minutes after placing cement during surgery, Time 3: Approximately 10-15 minutes after opening the intraoperative leg tourniquet, Time 4: Postoperative 12th hour, Time 5: Postoperative 24th hour | The activated partial thromboplastin time (APTT) is a screening test which isolates the 'intrinsic' and 'common' pathways of the in vitro coagulation cascade model. Coagulation factors and cofactors within each pathway operate in concert to generate a fibrin clot end-point, the time taken to form the clot being the APTT. |
| Prothrombin Time (PT) | Time 1:Preoperative 24th hour, Time 2: Approximately 10-15 minutes after placing cement during surgery, Time 3: Approximately 10-15 minutes after opening the intraoperative leg tourniquet, Time 4: Postoperative 12th hour, Time 5: Postoperative 24th hour | Prothrombin Time (PT) : is an assay for evaluating the extrinsic pathway and common pathway of coagulation |
| International Normalised Ratio (INR) | Time 1:Preoperative 24th hour, Time 2: Approximately 10-15 minutes after placing cement during surgery, Time 3: Approximately 10-15 minutes after opening the intraoperative leg tourniquet, Time 4: Postoperative 12th hour, Time 5: Postoperative 24th hour | Measured value used to monitor treatment with anticoagulants and to provide information on how quickly the blood clots. INR value of 1 = no anticoagulation; INR value of 2 = coagulation is prolonged 2-fold; INR value of 3 = coagulation is prolonged 3-fold. |
| D-DİMER | Time 1:Preoperative 24th hour, Time 2: Approximately 10-15 minutes after placing cement during surgery, Time 3: Approximately 10-15 minutes after opening the intraoperative leg tourniquet, Time 4: Postoperative 12th hour, Time 5: Postoperative 24th hour | D-dimer (or D dimer) is a dimer that is a fibrin degradation product (FDP), a small protein fragment present in the blood after a blood clot is degraded by fibrinolysis. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Fibrinogen | Time 1:Preoperative 24th hour, Time 2: Approximately 10-15 minutes after placing cement during surgery, Time 3: Approximately 10-15 minutes after opening the intraoperative leg tourniquet, Time 4: Postoperative 12th hour, Time 5: Postoperative 24th hour | Is a soluble protein present in blood plasma, from which fibrin is produced by the action of the enzyme thrombin. |
| Lactat | Time 1:Preoperative 24th hour, Time 2: Approximately 10-15 minutes after placing cement during surgery, Time 3: Approximately 10-15 minutes after opening the intraoperative leg tourniquet, Time 4: Postoperative 12th hour, Time 5: Postoperative 24th hour | Lactate is a bi-product constantly produced in the body during normal metabolism and exercise |
| Mean arterial pressure | Time 1:Preoperative 24th hour, Time 2: Approximately 10-15 minutes after placing cement during surgery, Time 3: Approximately 10-15 minutes after opening the intraoperative leg tourniquet, Time 4: Postoperative 12th hour, Time 5: Postoperative 24th hour | Mean arterial pressure (MAP) is the average arterial pressure throughout one cardiac cycle, systole, and diastole. Expressed in mmHg |
| Heart rate | Time 1:Preoperative 24th hour, Time 2: Approximately 10-15 minutes after placing cement during surgery, Time 3: Approximately 10-15 minutes after opening the intraoperative leg tourniquet, Time 4: Postoperative 12th hour, Time 5: Postoperative 24th hour | Heart rate is the frequency of the heartbeat measured by the number of contractions of the heart per minute |
| C reactive protein (CRP) | Time 1:Preoperative 24th hour, Time 2: Approximately 10-15 minutes after placing cement during surgery, Time 3: Approximately 10-15 minutes after opening the intraoperative leg tourniquet, Time 4: Postoperative 12th hour, Time 5: Postoperative 24th hour | C-reactive protein (CRP) is an annular pentameric protein found in blood plasma, whose circulating concentrations rise in response to inflammation |
| Interleukin 1 | Time 1:Preoperative 24th hour, Time 2: Approximately 10-15 minutes after placing cement during surgery, Time 3: Approximately 10-15 minutes after opening the intraoperative leg tourniquet, Time 5: Postoperative 24th hour | It is an inflammatory cytokine that has various physiological functions and pathological significance, playing an important role in health and disease. |
| Interleukin 6 | Time 1:Preoperative 24th hour, Time 2: Approximately 10-15 minutes after placing cement during surgery, Time 3: Approximately 10-15 minutes after opening the intraoperative leg tourniquet, Time 5: Postoperative 24th hour | Is a potent anti-inflammatory cytokine that plays a crucial, and often essential, role in preventing inflammatory and autoimmune pathologies. |
| Interleukin 10 | Time 1:Preoperative 24th hour, Time 2: Approximately 10-15 minutes after placing cement during surgery, Time 3: Approximately 10-15 minutes after opening the intraoperative leg tourniquet, Time 5: Postoperative 24th hour | Is a soluble mediator with pleiotropic effects on inflammation, immune response and hematopoiesis. |
| Tumor necrosis factor alfa (TNF alfa) | Time 1:Preoperative 24th hour, Time 2: Approximately 10-15 minutes after placing cement during surgery, Time 3: Approximately 10-15 minutes after opening the intraoperative leg tourniquet, Time 4: Postoperative 12th hour | Is a cytokine that has pleiotropic effects on various cell types and has been identified as a major regulator of inflammatory responses and plays a role in the pathogenesis of some inflammatory and autoimmune diseases. |
| Neutrophil to Lymphocyte Ratio | Time 1:Preoperative 24th hour, Time 2: Approximately 10-15 minutes after placing cement during surgery, Time 3: Approximately 10-15 minutes after opening the intraoperative leg tourniquet, Time 4: Postoperative 12th hour, Time 5: Postoperative 24th hour | The neutrophil-to-lymphocyte ratio (NLR), calculated as a simple ratio between the neutrophil and lymphocyte counts measured in peripheral blood, is a biomarker which conjugates two faces of the immune system: the innate immune response, mainly due to neutrophils, and adaptive immunity, supported by lymphocytes |
| Procalcitonin | Time 1:Preoperative 24th hour, Time 2: Approximately 10-15 minutes after placing cement during surgery, Time 3: Approximately 10-15 minutes after opening the intraoperative leg tourniquet, Time 4: Postoperative 12th hour, Time 5: Postoperative 24th hour | It is considered a biomarker specific to bacterial infections. |
| Ferritin | Time 1:Preoperative 24th hour, Time 2: Approximately 10-15 minutes after placing cement during surgery, Time 3: Approximately 10-15 minutes after opening the intraoperative leg tourniquet, Time 4: Postoperative 12th hour, Time 5: Postoperative 24th hour | Ferritin is an iron storage protein that also plays a role in numerous other conditions, including inflammatory, neurodegenerative and malignant diseases. |
| D-dimer | Time 1:Preoperative 24th hour, Time 2: Approximately 10-15 minutes after placing cement during surgery, Time 3: Approximately 10-15 minutes after opening the intraoperative leg tourniquet, Time 4: Postoperative 12th hour, Time 5: Postoperative 24th hour | D-dimer is a byproduct of the blood clotting and breakdown process. |
Countries
Turkey (Türkiye)
Outcome results
None listed