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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

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

Studiesteder

    • Jiangsu
      • Xuzhou, Jiangsu, Kina
        • The Affiliated Hospital of Xuzhou Medical University
        • Kontakt:

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
Group Aspirin
The elderly patients who using Aspirin at least three months before operation were in the Group Aspirin
Group Control
The elderly patients who not using Aspirin before operation were in the Group Control

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
The incidence of short-term POCD (Postoperative Cognitive Dysfunction)
Tidsramme: within one week after surgery
As measured by Mini-Mental State Examination
within one week after surgery

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
at 1th month after surgery
The incidence of postoperative delirium
Tidsramme: within one week after surgery
As measured by the Confusion Assessment Method
within one week after surgery

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

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

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

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