The Influence of Sedation for Endoscopy on Cognitive Function

The Influence of Sedation for Endoscopy on Cognitive Function

Patrocinadores

Patrocinador principal: Shanghai Jiao Tong University School of Medicine

Fuente Shanghai Jiao Tong University School of Medicine
Resumen breve

It is commonly recommended that patients should refrain from driving for 24 hours after sedation for endoscopy,however,this recommendation has been queried recently.To investigate the effect of sedation on early postoperative cognitive function in patients undergoing endoscopy.

Descripción detallada

One hundred adult patients undergoing sedative esophagogastroduodenoscopy ( EGD) were randomly recruited,and another 100 adult patients undergoing conventional(without sedation) EGD were served as controls. All patients had an education level more than 9 years. Cognitive function was assessed by Montreal Cognitive Assessment(MoCA)1 week before EGD exam, 10 mins before propofol sedation or the beginning of endoscopic procedure, 30mins after EGD exam, and 2 week after exam.

Estado general Terminated
Fecha de inicio November 14, 2019
Fecha de Terminación November 14, 2019
Fecha de finalización primaria November 14, 2019
Tipo de estudio Observational
Resultado primario
Medida Periodo de tiempo
NCT-A test outcome measure 30 minutes
DST test outcome measure 30 minutes
number cancellation test outcome measure 30 minutes
Resultado secundario
Medida Periodo de tiempo
heart rate outcome measure 5 minutes
SpO2 outcome measure 5 minutes
Inscripción 200
Condición
Intervención

Tipo de intervención: Drug

Nombre de intervención: Propofol

Descripción: patients in sedation group will be intravenous injected propofol in bolus

Etiqueta de grupo de brazo: sedation group

Tipo de intervención: Device

Nombre de intervención: endoscopy

Descripción: endoscopy system

Otro nombre: Olympus Lucera Elite 290 system

Elegibilidad

Método de muestreo: Probability Sample

Criterios:

Inclusion Criteria:

1. The scores of MMSE are more than 26.

2. The AHA grade I and II.

Exclusion Criteria:

1. The AHA grade III, IV or V.

2. binge drinking.

3. Take sedatives, sleeping agents and some drug which may affect the study in a month.

4. Psychiatric disorders.

5. The dysfunction of heart, lung, liver and kidney.

Género: All

Edad mínima: 20 Years

Edad máxima: 64 Years

Voluntarios Saludables: No

Oficial general
Apellido Papel Afiliación
Wei-Ping Li Study Chair Renji Hospital, School of Medicine,Shanghai Jiao Tong University
Ubicación
Instalaciones: Department of Gastroenterology, Renji Hospital, Shanghai Institute of Digestive Diseases, Shanghai Jiao Tong University School of Medicine
Ubicacion Paises

China

Fecha de verificación

November 2019

Fiesta responsable

Tipo: Principal Investigator

Afiliación del investigador: Shanghai Jiao Tong University School of Medicine

Nombre completo del investigador: Zhizheng Ge

Título del investigador: Ren Ji Hospital, School of medicine, Shanghai Jiao Tong University

Palabras clave
Tiene acceso ampliado No
Condición Examinar
Grupo de brazo

Etiqueta: sedation group

Descripción: Patients undergo sedative esophagogastroduodenoscopy (EGD) and are intravenous injected propofol in bolus

Etiqueta: control group

Descripción: patients undergo conventional EGD

Datos del paciente Undecided
Información de diseño del estudio

Modelo de observación: Cohort

Perspectiva de tiempo: Prospective

Fuente: ClinicalTrials.gov