Long Term Postoperative Cognitive Dysfunction in the Elderly Patients
Phase 4 Study of Long Term Postoperative Cognitive Dysfunction After Laparoscopic Cholecystectomy in the Elderly Patients
Panoramica dello studio
Stato
Condizioni
Descrizione dettagliata
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.
Tipo di studio
Iscrizione (Anticipato)
Fase
- Fase 4
Contatti e Sedi
Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Sessi ammissibili allo studio
Descrizione
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
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Diagnostico
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione parallela
- Mascheramento: Doppio
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
|---|---|
|
Comparatore attivo: 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.
|
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.
Altri nomi:
|
|
Comparatore attivo: 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.
|
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.
Altri nomi:
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.
Altri nomi:
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.
Altri nomi:
|
Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
The incidence of long-term postoperative cognitive dysfunction after general anesthesia in elderly patients.
Lasso di tempo: 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
|
Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
The difference of incidence in postoperative cognitive dysfunction after general anesthesia according to the anesthetic drugs
Lasso di tempo: 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
|
Collaboratori e investigatori
Investigatori
- Cattedra di studio: Seung-Hoon Baek, Pusan National University Yangsan Hospital
Studiare le date dei record
Studia le date principali
Inizio studio
Completamento primario (Anticipato)
Completamento dello studio (Anticipato)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Stima)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Stima)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Termini MeSH pertinenti aggiuntivi
- Disordini mentali
- Processi patologici
- Complicanze postoperatorie
- Disturbi neurocognitivi
- Disturbi cognitivi
- Disfunzione cognitiva
- Complicanze cognitive postoperatorie
- Effetti fisiologici delle droghe
- Agenti adrenergici
- Agenti neurotrasmettitori
- Meccanismi molecolari dell'azione farmacologica
- Depressori del sistema nervoso centrale
- Agenti del sistema nervoso periferico
- Analgesici
- Agenti del sistema sensoriale
- Anestetici, per via endovenosa
- Anestetici, Generale
- Anestetici
- Analgesici, non narcotici
- Inibitori dell'aggregazione piastrinica
- Agonisti del recettore adrenergico alfa-2
- Alfa-agonisti adrenergici
- Agonisti adrenergici
- Ipnotici e sedativi
- Anestetici, Inalazione
- Propofol
- Dexmedetomidina
- Sevoflurano
Altri numeri di identificazione dello studio
- LPOCD60
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .