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
1 other identifier
interventional
130
1 country
1
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Nov 2018
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 15, 2018
CompletedFirst Posted
Study publicly available on registry
November 19, 2018
CompletedStudy Start
First participant enrolled
November 20, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 20, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
December 25, 2018
CompletedNovember 19, 2018
November 1, 2018
1 month
October 15, 2018
November 16, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (10)
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
Study Arms (2)
General Anesthesia
ACTIVE COMPARATORThe 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
ACTIVE COMPARATORThe 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.
Interventions
The patients in general anesthesia group will undergo general anesthesia
The patients in Group R will be given combined spinoepidural anesthesia
Eligibility Criteria
You may qualify if:
- Patients scheduled to undergo elective unilateral total knee arthroplasty
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Ufuk Universitylead
Study Sites (1)
Ufuk University Dr. Rıdvan Ege Hospital
Ankara, 06520, Turkey (Türkiye)
Related Publications (2)
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.
PMID: 23612126BACKGROUNDStundner 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.
PMID: 23080348BACKGROUND
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- DIAGNOSTIC
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Primary Investigator
Study Record Dates
First Submitted
October 15, 2018
First Posted
November 19, 2018
Study Start
November 20, 2018
Primary Completion
December 20, 2018
Study Completion
December 25, 2018
Last Updated
November 19, 2018
Record last verified: 2018-11
Data Sharing
- IPD Sharing
- Will not share