Postoperative Complications Following Total Knee Arthroplasty

Ufuk University

Status: Unknown

Conditions: Arthroplasty, Replacement, Knee

Treatments: Other: General Anesthesia; Other: Regional Anesthesia

Study type: Interventional

Funder types: Other

Identifiers

NCT03746444

1001201311

Details and patient eligibility

About

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

Full description

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.

Enrollment: 130 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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130 participants in 2 patient groups

General Anesthesia

Active Comparator group

Description:

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.

Treatment:

Other: General Anesthesia

Regional Anesthesia

Active Comparator group

Description:

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.

Treatment:

Other: Regional Anesthesia