Arthroplasty, Replacement, KneeNCT03746444
Postoperative Complications Following Total Knee Arthroplasty
A study testing General Anesthesia and Regional Anesthesia in people with Arthroplasty, Replacement, Knee, run by Ufuk University at 1 site in Turkey (Türkiye).
Trial 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 Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Arthroplasty, Replacement, Knee
- What is being tested?
- General Anesthesia and Regional Anesthesia
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 130 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 20 Nov 2018to 25 Dec 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients scheduled to undergo elective unilateral total knee arthroplasty
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Ufuk University Dr. Rıdvan Ege Hospital
Ankara, 06520
Perihan Ekmekçi, MD, +903122044000 ext. 4099, erdogduperi@gmail.com
Perihan Ekmekçi, MD
About this study
Official title: 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
Read the 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.
- Conditions
- Arthroplasty, Replacement, Knee
- Being tested
- General Anesthesia, Regional Anesthesia
- Keywords
- total knee arthroplasty, general anesthesia, neuraxial anesthesia, complications
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
General AnesthesiaOther
The patients in general anesthesia group will undergo general anesthesia
Regional AnesthesiaOther
The patients in Group R will be given combined spinoepidural anesthesia
| Study group | Role | What they receive |
|---|---|---|
| General Anesthesia | Active comparator | 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. Receives: Other: General Anesthesia |
| Regional Anesthesia | Active comparator | 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. Receives: Other: Regional Anesthesia |
What is being measured
The primary outcome is the main question the study is designed to answer.
Acute Kidney Injury
Number of participants with new onset acute kidney injury
Measured: Postoperative first day
Acute Kidney Injury
Number of participants with new onset acute kidney injury
Measured: Postoperative sixth week
Pulmonary Thromboembolism
Number of participants with new onset pulmonary thromboembolism
Measured: Postoperative first day
Pulmonary Thromboembolism
Number of participants with new onset pulmonary thromboembolism
Measured: Postoperative sixth week
Infection
Number of participants with new onset infection
Measured: Postoperative first day
Infection
Number of participants with new onset infection
Measured: Postoperative sixth week
Arryhthmia
Number of participants with new onset arryhthmia requiring treatment
Measured: Postoperative first day
Arryhthmia
Number of participants with new onset arryhthmia requiring treatment
Measured: Postoperative sixth week
Death
Number of participants with mortality
Measured: Postoperative first day
Death
Number of participants with mortality
Measured: Postoperative sixth week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Nov 2018
- Study start20 Nov 2018 (estimated)
- Primary completion20 Dec 2018 (estimated)
- Study completion25 Dec 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Arthroplasty, Replacement, KneeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 130 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ufuk University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Perihan Ekmekçi, Ufuk University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03746444
- Sponsor's protocol ID
- 1001201311
- Status last verified
- Nov 2018
- First submitted
- 15 Oct 2018
- Last updated
- 19 Nov 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 23612126Stundner 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.
PubMed 23080348
Study at a glance
From the registry record, last updated by the sponsor on 19 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Effects of Combined Spinoepidural and General Anesthesia Effects on Incidence of Postoperative Complications Following Total Knee Arthroplasty
- ClinicalTrials.gov ID
- NCT03746444
- Acronym / sponsor ID
- 1001201311
- Conditions
- Arthroplasty, Replacement, Knee
- Keywords
- total knee arthroplasty, general anesthesia, neuraxial anesthesia, complications
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 130 participants (estimated)
- Lead sponsor
- Ufuk UniversityUniversity, hospital or other
- Study start
- 20 Nov 2018 (estimated)
- Primary completion
- 20 Dec 2018 (estimated)
- Study completion
- 25 Dec 2018 (estimated)
- First posted
- 19 Nov 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| General Anesthesia | Active comparator | Other: General AnesthesiaThe 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 comparator | Other: Regional AnesthesiaThe 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients scheduled to undergo elective unilateral total knee arthroplasty
Key exclusion criteria (6 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| General AnesthesiaThe patients in general anesthesia group will undergo general anesthesia | Other | General Anesthesia |
| Regional AnesthesiaThe patients in Group R will be given combined spinoepidural anesthesia | Other | Regional Anesthesia |
Primary outcome
Acute Kidney Injury
Time frame: Postoperative first day
Number of participants with new onset acute kidney injury
Acute Kidney Injury
Time frame: Postoperative sixth week
Number of participants with new onset acute kidney injury
Pulmonary Thromboembolism
Time frame: Postoperative first day
Number of participants with new onset pulmonary thromboembolism
Pulmonary Thromboembolism
Time frame: Postoperative sixth week
Number of participants with new onset pulmonary thromboembolism
Infection
Time frame: Postoperative first day
Number of participants with new onset infection
Infection
Time frame: Postoperative sixth week
Number of participants with new onset infection
Arryhthmia
Time frame: Postoperative first day
Number of participants with new onset arryhthmia requiring treatment
Arryhthmia
Time frame: Postoperative sixth week
Number of participants with new onset arryhthmia requiring treatment
Death
Time frame: Postoperative first day
Number of participants with mortality
Death
Time frame: Postoperative sixth week
Number of participants with mortality
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Nov 2018.
- Background: PubMed 23612126Memtsoudis 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.
- Background: PubMed 23080348Stundner 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing General Anesthesia and Regional Anesthesia in people with Arthroplasty, Replacement, Knee, run by Ufuk University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 19 Nov 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Perihan Ekmekçi, MD (+903122044000 ext. 4099, erdogduperi@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Acute Kidney Injury (time frame: Postoperative first day). The study lists 10 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03746444, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Nov 2018.