Postoperative Complications Following Total Knee Arthroplasty

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

130 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-11-20

Study Completion Date

2018-12-25

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

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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.

Conditions

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Arthroplasty, Replacement, Knee

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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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.

Group Type ACTIVE_COMPARATOR

General Anesthesia

Intervention Type OTHER

The patients in general anesthesia group will undergo general 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.

Group Type ACTIVE_COMPARATOR

Regional Anesthesia

Intervention Type OTHER

The patients in Group R will be given combined spinoepidural anesthesia

Interventions

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General Anesthesia

The patients in general anesthesia group will undergo general anesthesia

Intervention Type OTHER

Regional Anesthesia

The patients in Group R will be given combined spinoepidural anesthesia

Intervention Type OTHER

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

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No