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Long Term Postoperative Cognitive Dysfunction in the Elderly Patients

1. december 2014 opdateret af: Eun-Jung Kim, Pusan National University Yangsan Hospital

Phase 4 Study of Long Term Postoperative Cognitive Dysfunction After Laparoscopic Cholecystectomy in the Elderly Patients

The purposes of this study are to determine whether long-term postoperative cognitive dysfunction (POCD) is occured after general anesthesia and anesthetic drugs have an effect on the result about POCD.

Studieoversigt

Status

Ukendt

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

In present aging society, a surgery in geriatric patient is increasing. Patients older than 60 year are particularly affected for postoperative cognitive dysfunction (POCD) (26-41%). The patients experiencing POCD are at an increased risk of death in the first year after surgery. So, POCD is important because it can influence to patient's quality of life.

In the investigator's hospital, laparoscopic cholecystectomy is performed with increasing frequency in aging patients. So the investigator's study will be conducted in elderly patients during laparoscopic cholecystectomy. The anesthetic methods are divided into the following 3 kinds: sevoflurane, propofol, dexmedetomidine. These anesthetic drugs are used in general anesthesia generally. The control group include a spouse of the patient which must be older than 60 year and does not have anesthetic history.

After the surgery, the patients are discharged from the hospital, the investigators will check the postoperative cognitive function 4 times: 1week, 3months, 6months, 1 year later using the Korean version of telephone interview for cognitive status (TICS). The Korean version of TICS was validated tool for examination of cognitive function and this tool and mini-mental state examination (MMSE) be linked directly. The test will be administered to spouse simultaneously by telephone.

Sample size was calculated for the primary outcome parameters (whether long-term postoperative cognitive dysfunction (POCD) is occured after general anesthesia), and the investigators hypothesized that two groups are in this study, one group is for postanesthetic patients, another is for their spouses. Total sample size was calculated to 190.

Undersøgelsestype

Interventionel

Tilmelding (Forventet)

190

Fase

  • Fase 4

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

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

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

Inclusion Criteria:

  • ≥ 60 years old, scheduled for laparoscopic cholecystectomy under general anesthesia

Exclusion Criteria:

  • diseases of the central nervous system, including dementia (Mini Mental Examination Score <24),
  • consumption of major tranquilizers or antidepressants
  • previous neuropsychological testing
  • the patient's inability to comply and follow procedures or poor comprehension of the language used in the study.
  • Parkinson's disease
  • Patients with a severe visual or auditory handicap, illiteracy
  • alcoholism (intake of >5 units of alcohol daily during the last 3 months)
  • drug dependence
  • those not expected to complete the postoperative tests were excluded as well

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Diagnostisk
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Dobbelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Aktiv komparator: General anesthesia & Control
After the surgery, the patients are discharged from the hospital, investigators will check the postoperative cognitive function 4 times: 1weak, 3months, 6months, 1 year later using the intervention "Korean version of telephone interview for cognitive status (TICS)". The test will be administered to spouse simultaneously by telephone.
Adfærdsmæssigt: Korean version of telephone interview for cognitive status
The telephone interview for cognitive status (TICS), developed by Brandt et al. (1988), is one of the most popular telephone interview-based screening instruments. Especially, the Korean version of TICS is translated more suitable for Korean culture with the permission of the authors of the original version. The Korean version of TICS consists of 11 items, total score is 41.
Andre navne:
  • TICS
Aktiv komparator: Sevoflurane & Propofol & Dexmedetomidine
The anesthetic methods are divided into the following 3 kinds: Sevoflurane, Propofol, Dexmedetomidine. These anesthetic drugs are used in general anesthesia generally.
Medicin: Sevoflurane
Sevoflurane is one of the most commonly used volatile anesthetic agents, particularly for outpatient anesthesia, and including in anesthesia of children and infants, and in veterinary medicine.
Andre navne:
  • sevofrane
Medicin: propofol
Propofol is highly protein-bound in vivo and is metabolized by conjugation in the liver. The half-life of elimination of propofol has been estimated to be between 2 and 24 hours.
Andre navne:
  • fresofol
Enhed: dexmedetomidine
Dexmedetomidine is a sedative medication used by intensive care units and anesthesiologists. It is relatively unusual in its ability to provide sedation without causing respiratory depression.
Andre navne:
  • forudgående

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
The incidence of long-term postoperative cognitive dysfunction after general anesthesia in elderly patients.
Tidsramme: two years
Investigators will assess the postoperative cognitive dysfunction after general anesthesia in elderly patients compare to spouses which have no anesthetic history. Investigators will test participants using the Korean version of TICS and test will be done 1weak, 3months, 6months, 1 year after the surgery.
two years

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
The difference of incidence in postoperative cognitive dysfunction after general anesthesia according to the anesthetic drugs
Tidsramme: two years
Investigators will assess the postoperative cognitive dysfunction (POCD) after general anesthesia (sevoflurane, propofol and dexmedetomidine) and compare the occurrence rate of the POCD in 3 anesthetic methods.
two years

Samarbejdspartnere og efterforskere

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

Sponsor

Pusan National University Yangsan Hospital

Efterforskere

  • Studiestol: Seung-Hoon Baek, Pusan National University Yangsan Hospital

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

1. december 2014

Primær færdiggørelse (Forventet)

1. december 2016

Studieafslutning (Forventet)

1. december 2016

Datoer for studieregistrering

Først indsendt

8. oktober 2014

Først indsendt, der opfyldte QC-kriterier

23. november 2014

Først opslået (Skøn)

26. november 2014

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)

2. december 2014

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

1. december 2014

Sidst verificeret

1. november 2014

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • LPOCD60

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