Postoperative Cognitive FunctionNCT03909633
Effects of Intravenous Anesthesia on Postoperative Cognitive Function in Patients Accepted Painless Gastroenteroscopy
An observational study of Postoperative Cognitive Function, run by Second Affiliated Hospital, Zhejiang University, School of Medicine at 1 site in China.
Trial 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 Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Postoperative Cognitive Function
- What is being tested?
- a series of tests
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 1,000 participants
- Where
- 1 siteChina
- Study dates
- 1 Aug 2018to 1 Jun 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: patients will undergoing endoscopy check for all kinds of reasons
Who may be able to join
- 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
Who cannot join
- 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
Show all 13Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Cai Jian Ting
Hangzhou, Zhejiang, 310000
Cai J Ting, 15267019902 ext. 13805716757, 1173920428@qq.com
Chen Xiao, 15267019902 ext. 13805716757, 1173920428@qq.com
About this study
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
Read the 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 .
- Conditions
- Postoperative Cognitive Function
- Being tested
- a series of tests
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
a series of testsBehavioural
all patients in every group will do a series of tests,including DSST、DST、MoCA、WCST、HADS
| Study group | Role | What they receive |
|---|---|---|
| A: anesthesia group | Patients accepting endoscopy check under anesthesia will be included in this group as group A,will doing a series of tests Receives: 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 Receives: Behavioral: a series of tests |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Apr 2019
- Study start1 Aug 2018
- Primary completion1 Jun 2020 (estimated)
- Study completion1 Jun 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postoperative Cognitive FunctionStudies of the same condition, open and under way.
- More trials run by Second Affiliated Hospital, Zhejiang University, School of MedicineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,000 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Cai J Ting, Study chair, Second affiliated hospital of school of medicine, zhejiang university
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03909633
- Sponsor's protocol ID
- IR2018001085
- Status last verified
- Apr 2019
- First submitted
- 21 Oct 2018
- Last updated
- 10 Apr 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: to protect Patient privacy
Study at a glance
From the registry record, last updated by the sponsor on 10 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Intravenous Anesthesia on Postoperative Cognitive Function in Patients Accepted Painless Gastroenteroscopy
- ClinicalTrials.gov ID
- NCT03909633
- Acronym / sponsor ID
- IR2018001085
- Conditions
- Postoperative Cognitive Function
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- Second Affiliated Hospital, Zhejiang University, School of MedicineUniversity, hospital or other
- Study start
- 1 Aug 2018 (actual)
- Primary completion
- 1 Jun 2020 (estimated)
- Study completion
- 1 Jun 2020 (estimated)
- First posted
- 10 Apr 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| A: anesthesia group | – | Behavioral: a series of testsPatients accepting endoscopy check under anesthesia will be included in this group as group A,will doing a series of tests |
| B:Non-anesthesia group | – | Behavioral: a series of testspatients undergoing endoscopy check without anesthesia will be included in this group as controls voluntarily,namely group B,will doing a series of tests |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- patients will undergoing endoscopy check for all kinds of reasons
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (13 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| a series of testsall patients in every group will do a series of tests,including DSST、DST、MoCA、WCST、HADS | Behavioural | A: anesthesia group, B:Non-anesthesia group |
Primary outcome
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
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.
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.
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Apr 2019.
- Individual participant dataSharing planned: No. to protect Patient privacy
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Cai J Ting study chair
Second affiliated hospital of school of medicine, zhejiang university
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Postoperative Cognitive Function, run by Second Affiliated Hospital, Zhejiang University, School of Medicine at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 10 Apr 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Wang J AN (057187783759 ext. 057187783759, HREC2013@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in patient's cognitive dysfunction evaluated by WCST (time frame: 4 months). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Apr 2019.