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The Influence of Sedation for Endoscopy on Cognitive Function

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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
Sponsor:
Information provided by (Responsible Party):
Zhizheng Ge, Shanghai Jiao Tong University School of Medicine

Brief Summary:
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.

Condition or disease Intervention/treatment
Esophagogastroduodenoscopy Deep Sedation Cognition Disorders Drug: Propofol Device: endoscopy

Detailed Description:
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.

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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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Endoscopy
Drug Information available for: Propofol

Group/Cohort Intervention/treatment
sedation group
Patients undergo sedative esophagogastroduodenoscopy (EGD) and are intravenous injected propofol in bolus
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
Device: endoscopy
endoscopy system
Other Name: Olympus Lucera Elite 290 system




Primary Outcome Measures :
  1. 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.

  2. DST test outcome measure [ Time Frame: 30 minutes ]
    the score of DST for each patient is not less than that in the baseline.

  3. 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.


Secondary Outcome Measures :
  1. heart rate outcome measure [ Time Frame: 5 minutes ]
    heart rate less than 50 time per minute

  2. SpO2 outcome measure [ Time Frame: 5 minutes ]
    SpO2 less than 90%



Information from the National Library of Medicine

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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
Study Population
Radom select patients who undergo EGD in Renji Hospital, School of Medicine, Shanghai Jiaotong University. Patients who are recruited all received nine year compulsory education and fit for the inclusion criteria. Moreover, all patients received approval from the local institutional review board.
Criteria

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.

Information from the National Library of Medicine

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


Locations
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China, Shanghai
Department of Gastroenterology, Renji Hospital, Shanghai Institute of Digestive Diseases, Shanghai Jiao Tong University School of Medicine
Shanghai, Shanghai, China, 200127
Sponsors and Collaborators
Shanghai Jiao Tong University School of Medicine
Investigators
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Study Chair: Wei-Ping Li Renji Hospital, School of Medicine,Shanghai Jiao Tong University
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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

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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
Keywords provided by Zhizheng Ge, Shanghai Jiao Tong University School of Medicine:
Esophagogastroduodenoscopy
Deep Sedation
Cognition Disorders
Patient Discharge
Automobile Driving
Additional relevant MeSH terms:
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Cognition Disorders
Neurocognitive Disorders
Mental Disorders
Propofol
Hypnotics and Sedatives
Central Nervous System Depressants
Physiological Effects of Drugs
Anesthetics, Intravenous
Anesthetics, General
Anesthetics