Effects of Intravenous Anesthesia on Postoperative Cognitive Function in Patients Accepted Painless Gastroenteroscopy

April 8, 2019 updated by: Second Affiliated Hospital, School of Medicine, Zhejiang University
The investigators want to study the effect of intravenous anesthesia on postoperative cognitive function in patients accepted gastroenteroscopy ,no additional medication or operation is involved

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Unknown

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

The investigators want to study the effect of intravenous anesthesia on postoperative cognitive function in patients accepted gastroenteroscopy ,no additional medication or operation is involved.The investigators assess cognitive function through a series of tests for 4 times( within 3 days before the endoscopy ,2 hours after the endoscopy finished,1 week after the endoscopy,3 months after the endoscopy),including WCST、DSST、DST、HADS、MoCA,through self - contrast,the investigators will conclude whether intravenous anesthesia has bad impact on cognitive function or not .

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
1000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.
  • Name: Wang J AN
  • Phone Number: 057187783759 057187783759
  • Email: HREC2013@126.com

Study Contact Backup

Study Locations

  • China
    • Zhejiang
      • Hangzhou, Zhejiang, China, 310000
        • Recruiting
        • Cai Jian Ting
        • Contact:
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 80 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

patients will undergoing endoscopy check for all kinds of reasons

Description

Inclusion Criteria:

  • voluntary to participate in
  • Vital signs are stable
  • no drug or alcohol abuse
  • no mental illness
  • no severe central system diseases such as brain infarction
  • between 18 and 80
  • no liver or kidney dysfunction
  • will perform endoscopy for various reasons

Exclusion Criteria:

  • illiteracy
  • color blindness
  • can't write or refused to sign informed consent
  • unable to follow up regularly or cooperate with the examination
  • drug or alcohol abuse
  • hearing or visual serious impairment
  • has severe central nervous system diseases such as shoke ,neurosyphilis
  • uncontrolled high blood pressure or hyperglycemia
  • neurosyphilis
  • history of craniotomy for various reasons
  • liver and kidney dysfunction
  • non-digestive tumors
  • history of intravenous or general anesthesia for other causes in the last 3 months

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
A: anesthesia group
Patients accepting endoscopy check under anesthesia will be included in this group as group A,will doing a series of tests
Behavioral: a series of tests
all patients in every group will do a series of tests,including DSST、DST、MoCA、WCST、HADS
B:Non-anesthesia group
patients undergoing endoscopy check without anesthesia will be included in this group as controls voluntarily,namely group B,will doing a series of tests
Behavioral: a series of tests
all patients in every group will do a series of tests,including DSST、DST、MoCA、WCST、HADS

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Change in patient's cognitive dysfunction evaluated by WCST
Time Frame: 4 months
The Wisconsin Card Sorting Test (WCST) is a neuropsychological test of "set-shifting",.A number of stimulus cards are presented to the participant. The participant is told to match the cards, but not how to match; however, he or she is told whether a particular match is right or wrong. The test takes approximately 12-20 minutes to carry out and generates a number of psychometric scores, including numbers, percentages, and percentiles of: categories achieved, trials, errors, and perseverative errors
4 months
Change in patient's cognitive dysfunction evaluated by DST
Time Frame: 4 months
DST(Digit Span Test.),It is used to measure working memory's number storage capacity. Participants see or hear a sequence of numerical digits and are tasked to recall the sequence correctly, with increasingly longer sequences being tested in each trial. The participant's span is the longest number of sequential digits that can accurately be remembered. Digit-span tasks can be given forwards or backwards, meaning that once the sequence is presented, the participant is asked to either recall the sequence in normal or reverse order.Digit-span tasks are the most commonly used test for memory span, partially because performance on a digit-span task cannot be affected by factors such as semantics, frequency of appearance in daily life, complexity, etc.
4 months
Change in patient's cognitive dysfunction evaluated by DSST
Time Frame: 4 months
DSST(Digit Symbol Test).,The participants need to write the number referred to each symbol in 90 seconds.Number of hits are registered. The test measures short-term memory, visualspatial skills and attention.
4 months
Change in patient's cognitive dysfunction evaluated by MoCA
Time Frame: 4 months
MoCA （Montreal Cognitive Assessment）, The visual spatial executive ability, naming,memory, attention, language fluency, abstract,thinking, delayed memory and directional force are included in the test, a total of 30 points. The subjects whose have less than 12-year of education were added 1 point in the testing result, with correction of bias in the degree of culture. The patients whose get higher scores indicate that the cognitive function is better, 26 points as normal.
4 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Second Affiliated Hospital, School of Medicine, Zhejiang University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Chair: Cai J Ting, Second affiliated hospital of school of medicine, zhejiang university

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 1, 2018

Primary Completion (ANTICIPATED)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 1, 2020

Study Completion (ANTICIPATED)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 1, 2020

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 21, 2018

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 8, 2019

First Posted (ACTUAL)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 10, 2019

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 10, 2019

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 8, 2019

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2019

More Information

Terms related to this study

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • IR2018001085

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

to protect Patient privacy

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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