- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT04225702
Effect Of Aspirin Preoperative on Postoperative Cognitive Dysfunction In Elderly Patients Undergoing Knee Arthroplasty
8. januar 2020 opdateret af: Jin Dong Liu, Xuzhou Medical University
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.
Studieoversigt
Status
Ukendt
Detaljeret beskrivelse
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.
Undersøgelsestype
Observationel
Tilmelding (Forventet)
220
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiekontakt
- Navn: Jindong Liu, M.S
- Telefonnummer: +86-13951355136
- E-mail: liujindong1818@163.com
Studiesteder
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-
Jiangsu
-
Xuzhou, Jiangsu, Kina
- The Affiliated Hospital of Xuzhou Medical University
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Kontakt:
- Jindong Liu, M.S
- Telefonnummer: +86-13951355136
- E-mail: liujindong1818@163.com
-
-
Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
60 år og ældre (Voksen, Ældre voksen)
Tager imod sunde frivillige
Ja
Køn, der er berettiget til at studere
Alle
Prøveudtagningsmetode
Sandsynlighedsprøve
Studiebefolkning
Patients who have major hemorrhoea perioperative, admitted to ICU postoperative and refuse participating the following up are screened out from the research.
Beskrivelse
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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;
- Emergency surgery;
- Serious systemic diseases;
- Preoperative delirium and/ or cognitive dysfunction preoperative;
- History of hospitalization 3 months before surgery.
- Participating in other research
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
Kohorter og interventioner
Gruppe / kohorte |
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Group Aspirin
The elderly patients who using Aspirin at least three months before operation were in the Group Aspirin
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Group Control
The elderly patients who not using Aspirin before operation were in the Group Control
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
The incidence of short-term POCD (Postoperative Cognitive Dysfunction)
Tidsramme: within one week after surgery
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As measured by Mini-Mental State Examination
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within one week after surgery
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Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
Aspirin can increase the long-term cognitive function scores after surgery
Tidsramme: at 1th month after surgery
|
followed up by the Telephone Interview for Cognitive Status-Modified
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at 1th month after surgery
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The incidence of postoperative delirium
Tidsramme: within one week after surgery
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As measured by the Confusion Assessment Method
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within one week after surgery
|
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Efterforskere
- Ledende efterforsker: Jindong Liu, M.S, The Affiliated Hospital of Xuzhou Medical University
Publikationer og nyttige links
Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.
Generelle publikationer
- Zhang Y, Jordan JM. Epidemiology of osteoarthritis. Clin Geriatr Med. 2010 Aug;26(3):355-69. doi: 10.1016/j.cger.2010.03.001. Erratum In: Clin Geriatr Med. 2013 May;29(2):ix.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart (Forventet)
1. januar 2020
Primær færdiggørelse (Forventet)
30. juni 2020
Studieafslutning (Forventet)
30. juni 2020
Datoer for studieregistrering
Først indsendt
10. oktober 2019
Først indsendt, der opfyldte QC-kriterier
8. januar 2020
Først opslået (Faktiske)
13. januar 2020
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
13. januar 2020
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
8. januar 2020
Sidst verificeret
1. januar 2020
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- XYFY2019-KL05
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