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Postoperative Complications Following Total Knee Arthroplasty

Primary Purpose

Arthroplasty, Replacement, Knee

Status
Unknown status
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
General Anesthesia
Regional Anesthesia
Sponsored by
Ufuk University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Arthroplasty, Replacement, Knee focused on measuring total knee arthroplasty, general anesthesia, neuraxial anesthesia, complications

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Ufuk University Dr. Rıdvan Ege HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

General Anesthesia

Regional Anesthesia

Arm 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.

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
October 15, 2018
Last Updated
November 16, 2018
Sponsor
Ufuk University
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1. Study Identification

Unique Protocol Identification Number
NCT03746444
Brief Title
Postoperative Complications Following Total Knee Arthroplasty
Official Title
Comparison of Effects of Combined Spinoepidural and General Anesthesia Effects on Incidence of Postoperative Complications Following Total Knee Arthroplasty
Study Type
Interventional

2. Study Status

Record Verification Date
November 2018
Overall Recruitment Status
Unknown status
Study Start Date
November 20, 2018 (Anticipated)
Primary Completion Date
December 20, 2018 (Anticipated)
Study Completion Date
December 25, 2018 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ufuk University

4. Oversight

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
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Arthroplasty, Replacement, Knee
Keywords
total knee arthroplasty, general anesthesia, neuraxial anesthesia, complications

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
130 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
General Anesthesia
Arm Type
Active Comparator
Arm 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.
Arm Title
Regional Anesthesia
Arm Type
Active Comparator
Arm 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.
Intervention Type
Other
Intervention Name(s)
General Anesthesia
Intervention Description
The patients in general anesthesia group will undergo general anesthesia
Intervention Type
Other
Intervention Name(s)
Regional Anesthesia
Intervention Description
The patients in Group R will be given combined spinoepidural anesthesia
Primary Outcome Measure Information:
Title
Acute Kidney Injury
Description
Number of participants with new onset acute kidney injury
Time Frame
Postoperative first day
Title
Acute Kidney Injury
Description
Number of participants with new onset acute kidney injury
Time Frame
Postoperative sixth week
Title
Pulmonary Thromboembolism
Description
Number of participants with new onset pulmonary thromboembolism
Time Frame
Postoperative first day
Title
Pulmonary Thromboembolism
Description
Number of participants with new onset pulmonary thromboembolism
Time Frame
Postoperative sixth week
Title
Infection
Description
Number of participants with new onset infection
Time Frame
Postoperative first day
Title
Infection
Description
Number of participants with new onset infection
Time Frame
Postoperative sixth week
Title
Arryhthmia
Description
Number of participants with new onset arryhthmia requiring treatment
Time Frame
Postoperative first day
Title
Arryhthmia
Description
Number of participants with new onset arryhthmia requiring treatment
Time Frame
Postoperative sixth week
Title
Death
Description
Number of participants with mortality
Time Frame
Postoperative first day
Title
Death
Description
Number of participants with mortality
Time Frame
Postoperative sixth week

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Perihan Ekmekçi, MD
Phone
+903122044000
Ext
4099
Email
erdogduperi@gmail.com
Facility Information:
Facility Name
Ufuk University Dr. Rıdvan Ege Hospital
City
Ankara
ZIP/Postal Code
06520
Country
Turkey
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Perihan Ekmekçi, MD
Phone
+903122044000
Ext
4099
Email
erdogduperi@gmail.com
First Name & Middle Initial & Last Name & Degree
Perihan Ekmekçi, MD

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
23612126
Citation
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.
Results Reference
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PubMed Identifier
23080348
Citation
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.
Results Reference
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Postoperative Complications Following Total Knee Arthroplasty

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