The Influence of Sedation for Endoscopy on Cognitive Function
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ClinicalTrials.gov Identifier: NCT04168294 |
Recruitment Status :
Terminated
(The number of subjects did not meet the requirements)
First Posted : November 19, 2019
Last Update Posted : November 19, 2019
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Condition or disease | Intervention/treatment |
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Esophagogastroduodenoscopy Deep Sedation Cognition Disorders | Drug: Propofol Device: endoscopy |
Study Type : | Observational |
Actual Enrollment : | 200 participants |
Observational Model: | Cohort |
Time Perspective: | Prospective |
Official Title: | The Influence of Sedation for Endoscopy on Cognitive Function |
Actual Study Start Date : | November 14, 2019 |
Actual Primary Completion Date : | November 14, 2019 |
Actual Study Completion Date : | November 14, 2019 |

Group/Cohort | Intervention/treatment |
---|---|
sedation group
Patients undergo sedative esophagogastroduodenoscopy (EGD) and are intravenous injected propofol in bolus
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Drug: Propofol
patients in sedation group will be intravenous injected propofol in bolus Device: endoscopy endoscopy system
Other Name: Olympus Lucera Elite 290 system |
control group
patients undergo conventional EGD
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Device: endoscopy
endoscopy system
Other Name: Olympus Lucera Elite 290 system |
- NCT-A test outcome measure [ Time Frame: 30 minutes ]the score of NCT-A test for each patient is not less than that in the baseline.
- DST test outcome measure [ Time Frame: 30 minutes ]the score of DST for each patient is not less than that in the baseline.
- number cancellation test outcome measure [ Time Frame: 30 minutes ]the score of number cancellation test for each patient is not less than that in the baseline.
- heart rate outcome measure [ Time Frame: 5 minutes ]heart rate less than 50 time per minute
- SpO2 outcome measure [ Time Frame: 5 minutes ]SpO2 less than 90%

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Ages Eligible for Study: | 20 Years to 64 Years (Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Sampling Method: | Probability Sample |
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.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04168294
China, Shanghai | |
Department of Gastroenterology, Renji Hospital, Shanghai Institute of Digestive Diseases, Shanghai Jiao Tong University School of Medicine | |
Shanghai, Shanghai, China, 200127 |
Study Chair: | Wei-Ping Li | Renji Hospital, School of Medicine,Shanghai Jiao Tong University |
Responsible Party: | Zhizheng Ge, Ren Ji Hospital, School of medicine, Shanghai Jiao Tong University, Shanghai Jiao Tong University School of Medicine |
ClinicalTrials.gov Identifier: | NCT04168294 |
Other Study ID Numbers: |
rjyyxhk2017001 |
First Posted: | November 19, 2019 Key Record Dates |
Last Update Posted: | November 19, 2019 |
Last Verified: | November 2019 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | Undecided |
Studies a U.S. FDA-regulated Drug Product: | Yes |
Studies a U.S. FDA-regulated Device Product: | Yes |
Product Manufactured in and Exported from the U.S.: | No |
Esophagogastroduodenoscopy Deep Sedation Cognition Disorders Patient Discharge Automobile Driving |
Cognition Disorders Neurocognitive Disorders Mental Disorders Propofol Hypnotics and Sedatives |
Central Nervous System Depressants Physiological Effects of Drugs Anesthetics, Intravenous Anesthetics, General Anesthetics |