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
Descripción general del estudio
Estado
Condiciones
Descripción detallada
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 de estudio
Inscripción (Anticipado)
Fase
- Fase 4
Contactos y Ubicaciones
Estudio Contacto
- Nombre: Eun-Jung Kim
- Número de teléfono: 821025137881
- Correo electrónico: kejdream@gmail.com
Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
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
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Diagnóstico
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Doble
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
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Comparador activo: 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.
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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.
Otros nombres:
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Comparador activo: 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.
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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.
Otros nombres:
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.
Otros nombres:
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.
Otros nombres:
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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The incidence of long-term postoperative cognitive dysfunction after general anesthesia in elderly patients.
Periodo de tiempo: two years
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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.
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two years
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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The difference of incidence in postoperative cognitive dysfunction after general anesthesia according to the anesthetic drugs
Periodo de tiempo: two years
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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.
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two years
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Colaboradores e Investigadores
Patrocinador
Investigadores
- Silla de estudio: Seung-Hoon Baek, Pusan National University Yangsan Hospital
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio
Finalización primaria (Anticipado)
Finalización del estudio (Anticipado)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Estimar)
Actualizaciones de registros de estudio
Última actualización publicada (Estimar)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
- Desordenes mentales
- Procesos Patológicos
- Complicaciones Postoperatorias
- Trastornos neurocognitivos
- Trastornos cognitivos
- Disfunción congnitiva
- Complicaciones cognitivas posoperatorias
- Efectos fisiológicos de las drogas
- Agentes adrenérgicos
- Agentes neurotransmisores
- Mecanismos moleculares de acción farmacológica
- Depresores del sistema nervioso central
- Agentes del sistema nervioso periférico
- Analgésicos
- Agentes del sistema sensorial
- Anestésicos Intravenosos
- Anestésicos Generales
- Anestésicos
- Analgésicos no narcóticos
- Inhibidores de la agregación plaquetaria
- Agonistas del receptor adrenérgico alfa-2
- Agonistas alfa adrenérgicos
- Agonistas adrenérgicos
- Hipnóticos y sedantes
- Anestésicos, Inhalación
- Propofol
- Dexmedetomidina
- Sevoflurano
Otros números de identificación del estudio
- LPOCD60
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