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

NCT03909633 | Unknown

• 1 other identifier: IR2018001085
• Study Type: observational
• Target: 1,000
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Postoperative Cognitive Function

Outcome Measures

Primary Outcomes (4)

• 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

Study Arms (2)

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

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

Interventions

a series of tests BEHAVIORAL

all patients in every group will do a series of tests,including DSST、DST、MoCA、WCST、HADS

A: anesthesia group; B:Non-anesthesia group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

patients will undergoing endoscopy check for all kinds of reasons

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Second Affiliated Hospital, School of Medicine, Zhejiang University: lead

Study Sites (1)

Cai Jian Ting

Hangzhou, Zhejiang, 310000, China

RECRUITING

Study Officials

• Cai J Ting

  Second affiliated hospital of school of medicine, zhejiang university

  STUDY CHAIR

Central Study Contacts

Wang J AN

CONTACT

057187783759; HREC2013@126.com

Cai J Ting

CONTACT

15267019902; 1173920428@qq.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 21, 2018
• First Posted: April 10, 2019
• Study Start: August 1, 2018
• Primary Completion: June 1, 2020
• Study Completion: June 1, 2020
• Last Updated: April 10, 2019

Record last verified: 2019-04

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)