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Elective SurgeryNCT04225702

Effect Of Aspirin Preoperative on Postoperative Cognitive Dysfunction In Elderly Patients Undergoing Knee Arthroplasty

An observational study of Elective Surgery and Postoperative Cognitive Dysfunction, run by Xuzhou Medical University at 1 site in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

Studies have shown that the lifetime risk of developing symptomatic knee osteoarthritis is 40% in men and 47% in women; and the risk can be increased to 60% when the patient's BMI reaches 30 kg/m2. Read more about this study

Who is it for?
Ages 60 years and olderHealthy volunteers can take part
How many people
220 participants
Where
1 siteChina
Study dates
1 Jan 2020to 30 Jun 2020
Phase
Observational
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 60 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Study population: Patients who have major hemorrhoea perioperative, admitted to ICU postoperative and refuse participating the following up are screened out from the research.

Who may be able to join

  • Age more than 60 years old undergoing elective knee replacement with general anesthesia
  • ASA score grade I-III
  • Sign that informed consent is willing to participate in the study
  • Can communicate in verbal
  • The time of using aspirin is at least 3 months

Who cannot join

  • Central nervous system disease;
  • Mental illness before or now;
  • With using Antipsychotic treatment such as sedatives or antidepressants;
  • With drug dependence;
  • Severe visual, auditory, or motor impairment;
  • Acute infection;
Show all 11Show fewer
  • Emergency surgery;
  • Serious systemic diseases;
  • Preoperative delirium and/ or cognitive dysfunction preoperative;
  • History of hospitalization 3 months before surgery.
  • Participating in other research

Trial locations and contacts

1 site in 1 country.

Jindong Liu, M.S contact

+86-13951355136

liujindong1818@163.com

China1 site

  • The Affiliated Hospital of Xuzhou Medical University

    Xuzhou, Jiangsu

    Jindong Liu, M.S, +86-13951355136, liujindong1818@163.com

Other trials in China

About this study

Official title: Effect Of Long-term Aspirin Preoperative on Postoperative Cognitive Dysfunction In Elderly Patients Undergoing Knee Arthroplasty

Studies have shown that the lifetime risk of developing symptomatic knee osteoarthritis is 40% in men and 47% in women; and the risk can be increased to 60% when the patient's BMI reaches 30 kg/m2. In this population, knee replacement is the most common, effective, and cost-effective method in all treatments with reducing pain, improving joint function and quality of life. Postoperative cognitive dysfunction (POCD) is a common complication in the elderly, and its incidence can reach 25-40% in major non-cardiac surgery. As for POCD can prolong hospital stay, increase mortality and morbidity, and increase social and economic burden, it is especially important for the prevention and treatment of POCD. However, The mechanism of POCD is still unclear. Studies suggest that it may involve inflammation and oxidative stress in the central nervous system. But for the elderly, they are in a state of low inflammatory response. At the same time, surgery and tourniquets also can trigger or aggravate inflammatory response. Once the inflammatory factors released into the blood circulation, they can act on the central nervous system in a variety of ways. As a result,elderly patients are more likely to develop POCD. In addition, some studies have shown that pain can also increase cognitive burden. Aspirin, its pharmacodynamic effects includes anti-inflammatory and analgesic effects which may have a certain effect on the prevention of POCD.

Read the detailed description

Elderly patients undergoing knee replacement are more likely to develop POCD. The aim of this study is to determine the incidence of short-term POCD and long-term cognitive status in the elderly patients who use Aspirin atleast three months before knee replacement.And then, the study evaluates the effect of Aspirin on the incidence of postoperative delirium. In addition, it also shows the risk factors for POCD such as postoperative delirium, pain, C reactive protein and so on in the elderly patients who undergo knee replacement.

Medical subject headings
Postoperative Cognitive Complications

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT04225702
Study groupRoleWhat they receive
Group AspirinThe elderly patients who using Aspirin at least three months before operation were in the Group Aspirin
Group ControlThe elderly patients who not using Aspirin before operation were in the Group Control

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. The incidence of short-term POCD (Postoperative Cognitive Dysfunction)

    As measured by Mini-Mental State Examination

    Measured: within one week after surgery

Secondary outcomes (2)

  1. Aspirin can increase the long-term cognitive function scores after surgery

    followed up by the Telephone Interview for Cognitive Status-Modified

    Measured: at 1th month after surgery

  2. The incidence of postoperative delirium

    As measured by the Confusion Assessment Method

    Measured: within one week after surgery

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 Jan 2020
  2. Study start1 Jan 2020 (estimated)
  3. Primary completion30 Jun 2020 (estimated)
  4. Study completion30 Jun 2020 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
220 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04225702
Sponsor's protocol ID
XYFY2019-KL05
Status last verified
Jan 2020
First submitted
10 Oct 2019
Last updated
13 Jan 2020
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Zhang Y, Jordan JM. Epidemiology of osteoarthritis. Clin Geriatr Med. 2010 Aug;26(3):355-69. doi: 10.1016/j.cger.2010.03.001.

    PubMed 20699159

  • Murphy L, Schwartz TA, Helmick CG, Renner JB, Tudor G, Koch G, Dragomir A, Kalsbeek WD, Luta G, Jordan JM. Lifetime risk of symptomatic knee osteoarthritis. Arthritis Rheum. 2008 Sep 15;59(9):1207-13. doi: 10.1002/art.24021.

    PubMed 18759314

  • Price AJ, Alvand A, Troelsen A, Katz JN, Hooper G, Gray A, Carr A, Beard D. Knee replacement. Lancet. 2018 Nov 3;392(10158):1672-1682. doi: 10.1016/S0140-6736(18)32344-4.

    PubMed 30496082

  • Hasanain MS, Apostu D, Alrefaee A, Tarabichi S. Comparing the Effect of Tourniquet vs Tourniquet-Less in Simultaneous Bilateral Total Knee Arthroplasties. J Arthroplasty. 2018 Jul;33(7):2119-2124. doi: 10.1016/j.arth.2018.02.013. Epub 2018 Feb 15.

    PubMed 29510953

  • Ottens TH, Dieleman JM, Sauer AM, Peelen LM, Nierich AP, de Groot WJ, Nathoe HM, Buijsrogge MP, Kalkman CJ, van Dijk D; DExamethasone for Cardiac Surgery (DECS) Study Group. Effects of dexamethasone on cognitive decline after cardiac surgery: a randomized clinical trial. Anesthesiology. 2014 Sep;121(3):492-500. doi: 10.1097/ALN.0000000000000336.

    PubMed 25225745

  • Valentin LS, Pereira VF, Pietrobon RS, Schmidt AP, Oses JP, Portela LV, Souza DO, Vissoci JR, Luz VF, Trintoni LM, Nielsen KC, Carmona MJ. Effects of Single Low Dose of Dexamethasone before Noncardiac and Nonneurologic Surgery and General Anesthesia on Postoperative Cognitive Dysfunction-A Phase III Double Blind, Randomized Clinical Trial. PLoS One. 2016 May 6;11(5):e0152308. doi: 10.1371/journal.pone.0152308. eCollection 2016.

    PubMed 27152422

  • Steinmetz J, Christensen KB, Lund T, Lohse N, Rasmussen LS; ISPOCD Group. Long-term consequences of postoperative cognitive dysfunction. Anesthesiology. 2009 Mar;110(3):548-55. doi: 10.1097/ALN.0b013e318195b569.

    PubMed 19225398

  • Roach GW, Kanchuger M, Mangano CM, Newman M, Nussmeier N, Wolman R, Aggarwal A, Marschall K, Graham SH, Ley C. Adverse cerebral outcomes after coronary bypass surgery. Multicenter Study of Perioperative Ischemia Research Group and the Ischemia Research and Education Foundation Investigators. N Engl J Med. 1996 Dec 19;335(25):1857-63. doi: 10.1056/NEJM199612193352501.

    PubMed 8948560

  • Skvarc DR, Berk M, Byrne LK, Dean OM, Dodd S, Lewis M, Marriott A, Moore EM, Morris G, Page RS, Gray L. Post-Operative Cognitive Dysfunction: An exploration of the inflammatory hypothesis and novel therapies. Neurosci Biobehav Rev. 2018 Jan;84:116-133. doi: 10.1016/j.neubiorev.2017.11.011. Epub 2017 Nov 26.

    PubMed 29180259

Questions about this trial

What is this clinical trial studying?

An observational study of Elective Surgery and Postoperative Cognitive Dysfunction, run by Xuzhou Medical University at 1 site in China.

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 5 inclusion and 11 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 13 Jan 2020. 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 China. 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 Jindong Liu, M.S (+86-13951355136, liujindong1818@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

The incidence of short-term POCD (Postoperative Cognitive Dysfunction) (time frame: within one week after surgery). 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 NCT04225702, which also lists 9 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 13 Jan 2020.

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