Clinical trial NCT07002086: Effects of Tourniquet Applied During Total Knee Replacement Surgery on Patient Hemodynamics and Blood Table
Official title: The Effects of Tourniquet Applied to the Lower Extremity During Total Knee Replacement Surgery on Hemodynamics, ETCO2, SpO2 and Blood Picture of Patients
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Primary Gonarthrosis
Lead sponsor: Saglik Bilimleri Universitesi Gazi Yasargil Training and Research Hospital
Sponsor class: OTHER
First posted: 2025-06-03
Enrollment: 17
Sex: ALL
Minimum age (years): 65
Maximum age (years): 90
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients undergoing knee replacement surgery

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

Eligibility criteria: 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

Primary outcomes:
measure: Activated Partial Thromboplastin Time(APTT)
timeFrame: 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
measure: Prothrombin Time (PT)
timeFrame: 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
measure: International Normalised Ratio (INR)
timeFrame: 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
measure: D-DİMER
timeFrame: 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
Secondary outcomes:
measure: C reactive protein (CRP)
timeFrame: 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
measure: Procalcitonin
timeFrame: 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
measure: Ferritin
timeFrame: 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
measure: D-dimer
timeFrame: 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
measure: Fibrinogen
timeFrame: 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
measure: Lactat
timeFrame: 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
measure: Mean arterial pressure
timeFrame: 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
measure: Heart rate
timeFrame: 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
measure: Neutrophil to Lymphocyte Ratio
timeFrame: 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
measure: Interleukin 1
timeFrame: 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
measure: Interleukin 6
timeFrame: 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
measure: Interleukin 10
timeFrame: 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
measure: Tumor necrosis factor alfa (TNF alfa)
timeFrame: 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
Other outcomes:
Locations:
city: Diyarbakır
country: Turkey
facility: Saglik Bilimleri Universitesi Gazi Yasargil Training and Research Hospital
city: Diyarbakır
country: Turkey
facility: Saglik Bilimleri Universitesi Gazi Yasargil Training and Research Hospital
Study officials:
affiliation: Saglik Bilimleri Universitesi Gazi Yasargil Training and Research Hospital
name: Fatma Acil, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Siirt University
name: Abdulkadir Yektaş, Prof. Dr.
role: STUDY_DIRECTOR
References: