Postoperative Complications Following Total Knee Arthroplasty

Study Overview
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Brief Summary
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The aim of this study is to investigate the effect of combined spinoepidural and general anesthesia on the incidence of postoperative complications following total knee arthroplasty

Detailed Description
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Total knee arthroplasty is known to cause complications (pulmonary thromboembolism, acute kidney injury, arryhthmias and infection). The investigators aimed to study the effects of two different anesthesia techniques, i.e. combined spinoepidural anesthesia and general anesthesia on the incidence of postoperative complications such as arrhythmia, pulmonary thrombeoembolism, infection, acute kidney injury and mortality.

Official Title
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Comparison of Effects of Combined Spinoepidural and General Anesthesia Effects on Incidence of Postoperative Complications Following Total Knee Arthroplasty

Conditions
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Arthroplasty, Replacement, Knee

Intervention / Treatment
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* Other: General Anesthesia
* Other: Regional Anesthesia


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients scheduled to undergo elective unilateral total knee arthroplasty Exclusion Criteria: Patient refusal Scheduled for bilateral or unilateral unicondylar knee arthroplasty Known history of allergy to drugs used in the study Severe systemic disease Morbid obesity (BMI>30) History of renal dysfunction

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: General Anesthesia<br>The patients in this group will undergo unilateral total knee arthroplasty under general anesthesia. Following vascular access and monitorization (non-invasive blood pressure, saturation, electrocardiography). Epidural chateterisation will be performed and test dose will be applied. Induction will be carried out using propofol (3mg/kg), fentanyl (1cmg/kg) and rocuronium (0.6 mg/kg). Maintenance will be carried out using sevoflurane (%2-3) and 50-50% mixture of nitrous oxide and oxygen. Epidural analgesia will be initiated after the end surgery. | Other: General Anesthesia<br>* The patients in general anesthesia group will undergo general anesthesia<br>|
| Active Comparator: Regional Anesthesia<br>The patients in this group will undergo unilateral total knee arthroplasty under combined spinoedpidural anesthesia . Following vascular access and monitorization (noninvasive blood pressure, oxygen saturation and electrocardiography), spinal anesthesia will be performed using 12,5 mg marcaine given to the subarachnoid space and epidural analgesia will be initiated at the end of surgery following negative test dose. The patients will be given nasal oxygen supplementation. | Other: Regional Anesthesia<br>* The patients in Group R will be given combined spinoepidural anesthesia<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Acute Kidney Injury | Number of participants with new onset acute kidney injury | Postoperative first day | 
| Acute Kidney Injury | Number of participants with new onset acute kidney injury | Postoperative sixth week | 
| Pulmonary Thromboembolism | Number of participants with new onset pulmonary thromboembolism | Postoperative first day | 
| Pulmonary Thromboembolism | Number of participants with new onset pulmonary thromboembolism | Postoperative sixth week | 
| Infection | Number of participants with new onset infection | Postoperative first day | 
| Infection | Number of participants with new onset infection | Postoperative sixth week | 
| Arryhthmia | Number of participants with new onset arryhthmia requiring treatment | Postoperative first day | 
| Arryhthmia | Number of participants with new onset arryhthmia requiring treatment | Postoperative sixth week | 
| Death | Number of participants with mortality | Postoperative first day | 
| Death | Number of participants with mortality | Postoperative sixth week | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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total knee arthroplasty, general anesthesia, neuraxial anesthesia, complications