Postoperative Complications Following Total Knee Arthroplasty

Not Applicable

• Conditions: Arthroplasty, Replacement, Knee
• Interventions: Other: General Anesthesia; Other: Regional Anesthesia

• Registration Number: NCT03746444
• Lead Sponsor: Ufuk University

Brief Summary

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

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.

Study Timeline

• Study First Submitted: 2018-10-15
• Status Verified: 2018-11
• Study First Submitted QC: 2018-11-16
• Last Update Submitted: 2018-11-16
• Study First Posted: 2018-11-19
• Last Update Posted: 2018-11-19
• Study Start: 2018-11-20
• Primary Completion: 2018-12-20
• Study Completion: 2018-12-25

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 130

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
General Anesthesia	General Anesthesia	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.
Regional Anesthesia	Regional Anesthesia	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.

Primary Outcome Measures

Name	Time	Method
Death	Postoperative sixth week	Number of participants with mortality
Pulmonary Thromboembolism	Postoperative sixth week	Number of participants with new onset pulmonary thromboembolism
Infection	Postoperative sixth week	Number of participants with new onset infection
Arryhthmia	Postoperative sixth week	Number of participants with new onset arryhthmia requiring treatment
Acute Kidney Injury	Postoperative sixth week	Number of participants with new onset acute kidney injury

Trial Locations

Locations (1)

Ufuk University Dr. Rıdvan Ege Hospital; 🇹🇷 Ankara, Turkey