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The Influence of Sedation for Endoscopy on Cognitive Function

Sponsor
Shanghai Jiao Tong University School of Medicine (Other)
Overall Status
Terminated
CT.gov ID
NCT04168294
Collaborator
(none)
200
Enrollment
1
Location

Study Details

Study Description

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 Phase

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.

Study Design

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 :
Nov 14, 2019
Actual Primary Completion Date :
Nov 14, 2019
Actual Study Completion Date :
Nov 14, 2019

Arms and Interventions

Arm 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 Names:
  • Olympus Lucera Elite 290 system

    		•
    control group

    patients undergo conventional EGD

    Device: endoscopy
    endoscopy system
    Other Names:
  • Olympus Lucera Elite 290 system

    		•

    Outcome Measures

    Primary Outcome Measures

    1. NCT-A test outcome measure [30 minutes]

      the score of NCT-A test for each patient is not less than that in the baseline.

    2. DST test outcome measure [30 minutes]

      the score of DST for each patient is not less than that in the baseline.

    3. number cancellation test outcome measure [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 [5 minutes]

      heart rate less than 50 time per minute

    2. SpO2 outcome measure [5 minutes]

      SpO2 less than 90%

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    20 Years to 64 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 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

    • Study Chair: Wei-Ping Li, Renji Hospital, School of Medicine,Shanghai Jiao Tong University

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    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:
    Nov 19, 2019
    Last Update Posted:
    Nov 19, 2019
    Last Verified:
    Nov 1, 2019
    Individual Participant Data (IPD) Sharing Statement:
    Undecided
    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
    Keywords provided by Zhizheng Ge, Ren Ji Hospital, School of medicine, Shanghai Jiao Tong University, Shanghai Jiao Tong University School of Medicine
    Esophagogastroduodenoscopy
    Deep Sedation
    Cognition Disorders
    Patient Discharge
    Automobile Driving
    Additional relevant MeSH terms:
    Cognition Disorders
    Propofol

    Study Results

    No Results Posted as of Nov 19, 2019