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

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: Unknown
• Conditions: Postoperative Cognitive Function
• Intervention / Treatment: Behavioral: a series of tests

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: Observational
• Enrollment (Anticipated): 1000

Contacts and Locations

Study Locations

• China
  • Zhejiang
    • Hangzhou, Zhejiang, China, 310000
      • Recruiting
      • Cai Jian Ting
      • Contact: Cai J Ting; Phone Number: 13805716757 15267019902; Email: 1173920428@qq.com
      • Contact: Chen Xiao; Phone Number: 13805716757 15267019902; Email: 1173920428@qq.com

Participation Criteria

Eligibility Criteria

• 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

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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

Outcome Measure	Measure Description	Time Frame
Change in patient's cognitive dysfunction evaluated by WCST	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	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	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	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

• Sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University
• Investigators: Study Chair: Cai J Ting, Second affiliated hospital of school of medicine, zhejiang university

Study record dates

Study Major Dates

• Study Start (ACTUAL): August 1, 2018
• Primary Completion (ANTICIPATED): June 1, 2020
• Study Completion (ANTICIPATED): June 1, 2020

Study Registration Dates

• First Submitted: October 21, 2018
• First Submitted That Met QC Criteria: April 8, 2019
• First Posted (ACTUAL): April 10, 2019

Study Record Updates

• Last Update Posted (ACTUAL): April 10, 2019
• Last Update Submitted That Met QC Criteria: April 8, 2019
• Last Verified: April 1, 2019

More Information

Terms related to this study

• Other Study ID 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