Postoperative Complications Following Total Knee Arthroplasty

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

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

Study Overview

• Status: Unknown
• Conditions: Arthroplasty, Replacement, Knee
• Intervention / Treatment: Other: General Anesthesia; Other: Regional Anesthesia

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 Type: Interventional
• Enrollment (Anticipated): 130
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey
  • Ankara, Turkey, 06520
    • Recruiting
    • Ufuk University Dr. Rıdvan Ege Hospital
    • Contact: Perihan Ekmekçi, MD; Phone Number: 4099 +903122044000; Email: erdogduperi@gmail.com
    • Principal Investigator: Perihan Ekmekçi, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: DIAGNOSTIC
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 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.	Other: General Anesthesia; The patients in general anesthesia group will undergo general anesthesia
Active Comparator: 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.	Other: Regional Anesthesia; The patients in Group R will be given combined spinoepidural anesthesia

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Ufuk University

Publications and helpful links

General Publications

• Memtsoudis SG, Sun X, Chiu YL, Stundner O, Liu SS, Banerjee S, Mazumdar M, Sharrock NE. Perioperative comparative effectiveness of anesthetic technique in orthopedic patients. Anesthesiology. 2013 May;118(5):1046-58. doi: 10.1097/ALN.0b013e318286061d. Erratum In: Anesthesiology. 2016 Sep;125(3):610.
• Stundner O, Chiu YL, Sun X, Mazumdar M, Fleischut P, Poultsides L, Gerner P, Fritsch G, Memtsoudis SG. Comparative perioperative outcomes associated with neuraxial versus general anesthesia for simultaneous bilateral total knee arthroplasty. Reg Anesth Pain Med. 2012 Nov-Dec;37(6):638-44. doi: 10.1097/AAP.0b013e31826e1494.

Study record dates

Study Major Dates

• Study Start (Anticipated): November 20, 2018
• Primary Completion (Anticipated): December 20, 2018
• Study Completion (Anticipated): December 25, 2018

Study Registration Dates

• First Submitted: October 15, 2018
• First Submitted That Met QC Criteria: November 16, 2018
• First Posted (Actual): November 19, 2018

Study Record Updates

• Last Update Posted (Actual): November 19, 2018
• Last Update Submitted That Met QC Criteria: November 16, 2018
• Last Verified: November 1, 2018

More Information

Terms related to this study

• Keywords: complications; general anesthesia; total knee arthroplasty; neuraxial anesthesia
• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Physiological Effects of Drugs; Central Nervous System Depressants; Anesthetics
• Other Study ID Numbers: 1001201311

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No