The Influence of Sedation for Endoscopy on Cognitive Function

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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The Influence of Sedation for Endoscopy on Cognitive Function

Conditions
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Esophagogastroduodenoscopy, Deep Sedation, Cognition Disorders

Intervention / Treatment
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* Drug: Propofol
* Device: endoscopy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: The scores of MMSE are more than 26. The AHA grade I and II. Exclusion Criteria: The AHA grade III, IV or V. binge drinking. Take sedatives, sleeping agents and some drug which may affect the study in a month. Psychiatric disorders. The dysfunction of heart, lung, liver and kidney.

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 64 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| sedation group<br>Patients undergo sedative esophagogastroduodenoscopy (EGD) and are intravenous injected propofol in bolus | Drug: Propofol<br>* patients in sedation group will be intravenous injected propofol in bolus<br>Device: endoscopy<br>* endoscopy system<br>* Other names: Olympus Lucera Elite 290 system;|
| control group<br>patients undergo conventional EGD | Device: endoscopy<br>* endoscopy system<br>* Other names: Olympus Lucera Elite 290 system;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| NCT-A test outcome measure | the score of NCT-A test for each patient is not less than that in the baseline. | 30 minutes | 
| DST test outcome measure | the score of DST for each patient is not less than that in the baseline. | 30 minutes | 
| number cancellation test outcome measure | the score of number cancellation test for each patient is not less than that in the baseline. | 30 minutes | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| heart rate outcome measure | heart rate less than 50 time per minute | 5 minutes | 
| SpO2 outcome measure | SpO2 less than 90% | 5 minutes | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Esophagogastroduodenoscopy, Deep Sedation, Cognition Disorders, Patient Discharge, Automobile Driving