Postoperative Cognitive DysfunctionNCT02992600
Postoperative Cognitive Dysfunction: Correlations With Olfactory Dysfunction and Related Gene Changes
An observational study of Postoperative Cognitive Dysfunction, run by Han Yuan at 1 site in China.
Trial summary
To study on the Postoperative Cognitive Dysfunction: Correlations With Olfactory Dysfunction and Related Gene Changes.To explore whether the olfactory dysfunction could be used as a predictor of POCD and to provide reference for POCD prevention, early detection and timely diagnosis and treatment. Read more about this study
- Who is it for?
- Ages 60 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Postoperative Cognitive Dysfunction
- How many people
- 300 participants
- Where
- 1 siteChina
- Study dates
- Dec 2016to Jul 2017
- How long will I take part?
- 7 Days
- 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 60 to 85 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: We included 300 male and female patients undergoing non-cardiac surgery at the Affiliated Hospital of Xuzhou Medical University and 30 healthy volunteers.
Who may be able to join
- Between 60 to 85 years old;
- Undergoing non-cardiac and non-neurological surgery under general anesthesia;
- Expected hospital stay ≥5 days;
- American Society of Anesthesiologists class I or II.
Who cannot join
- Mental or neurodegenerative diseases;
- History of severe trauma or surgery within one year;
- History of nasal or sinus illness or surgery;
- Cold or influenza within 3 weeks;
- Significant history of organ dysfunction;
- Previous neuropsychological testing;
- Difficulty to perform tests (including severe visual or auditory disorders);
- Mini-Mental State Examination (MMSE) <24 points, <20 points if the participant only attended elementary school, or <17 points if the participant did not go to school.
Trial locations and contacts
1 site in 1 country.
China1 site
Department of Anesthesia of the Affiliated Hospital of Xuzhou Medical University
Xuzhou, Jiangsu
About this study
To study on the Postoperative Cognitive Dysfunction: Correlations With Olfactory Dysfunction and Related Gene Changes.To explore whether the olfactory dysfunction could be used as a predictor of POCD and to provide reference for POCD prevention, early detection and timely diagnosis and treatment.
- Conditions
- Postoperative Cognitive Dysfunction
- Keywords
- non-cardiac surgery, Postoperative Cognitive Dysfunction
- Medical subject headings
- Postoperative Cognitive Complications
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| study group | 300 male and female patients undergoing non-cardiac surgery are enrolled at the Affiliated Hospital of Xuzhou Medical University [Jiangsu China]. Patients will be divided into POCD and non-POCD groups according to the scores of neuropsychological tests. | |
| control group | 30 healthy volunteers are enrolled for calculating the Z-scores of study group. |
What is being measured
The primary outcome is the main question the study is designed to answer.
the neuropsychological test battery to measure cognitive function
Measured: 1 day before surgery(baseline)
olfaction test to measure the sense of smell
Measured: 1 day before surgery(baseline)
the neuropsychological tests to measure cognitive function
Measured: within 5 to 10 days (average of 7 days) after surgery
olfaction test to measure the sense of smell
Measured: within 5 to 10 days (average of 7 days) after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Dec 2016 (estimated)
- Study startDec 2016
- Primary completionJul 2017
- Study completionJul 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postoperative Cognitive DysfunctionStudies of the same condition, open and under way.
- 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
- 300 participants (actual)
- Target duration
- 7 Days
Sponsor and investigators
- Lead sponsor
- Han Yuan
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Han Yuan, Xuzhou Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02992600
- Sponsor's protocol ID
- XYFY2016-KL018-01
- Status last verified
- Jul 2022
- First submitted
- 2 Dec 2016
- Last updated
- 25 Jul 2022
- Results posted
- No
- Individual data sharing
- Yes: within six months after the trial complete
Study at a glance
From the registry record, last updated by the sponsor on 25 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Postoperative Cognitive Dysfunction: Correlations With Olfactory Dysfunction and Related Gene Changes
- ClinicalTrials.gov ID
- NCT02992600
- Acronym / sponsor ID
- XYFY2016-KL018-01
- Conditions
- Postoperative Cognitive Dysfunction
- Keywords
- non-cardiac surgery, Postoperative Cognitive Dysfunction
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 300 participants (actual)
- Lead sponsor
- Han YuanUniversity, hospital or other
- Study start
- Dec 2016 (actual)
- Primary completion
- Jul 2017 (actual)
- Study completion
- Jul 2017 (actual)
- First posted
- 14 Dec 2016 (estimated)
- 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.
To study on the Postoperative Cognitive Dysfunction: Correlations With Olfactory Dysfunction and Related Gene Changes.To explore whether the olfactory dysfunction could be used as a predictor of POCD and to provide reference for POCD prevention, early detection and timely diagnosis and treatment.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 7 Days
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| study group | – | –300 male and female patients undergoing non-cardiac surgery are enrolled at the Affiliated Hospital of Xuzhou Medical University [Jiangsu China]. Patients will be divided into POCD and non-POCD groups according to the scores of neuropsychological tests. |
| control group | – | –30 healthy volunteers are enrolled for calculating the Z-scores of study group. |
Who may qualify
- Ages
- 60 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- We included 300 male and female patients undergoing non-cardiac surgery at the Affiliated Hospital of Xuzhou Medical University and 30 healthy volunteers.
Key inclusion criteria (4 listed)
- Between 60 to 85 years old;
- Undergoing non-cardiac and non-neurological surgery under general anesthesia;
- Expected hospital stay ≥5 days;
- American Society of Anesthesiologists class I or II.
Key exclusion criteria (8 listed)
- Mental or neurodegenerative diseases;
- History of severe trauma or surgery within one year;
- History of nasal or sinus illness or surgery;
- Cold or influenza within 3 weeks;
- Significant history of organ dysfunction;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
the neuropsychological test battery to measure cognitive function
Time frame: 1 day before surgery(baseline)
olfaction test to measure the sense of smell
Time frame: 1 day before surgery(baseline)
the neuropsychological tests to measure cognitive function
Time frame: within 5 to 10 days (average of 7 days) after surgery
olfaction test to measure the sense of smell
Time frame: within 5 to 10 days (average of 7 days) after surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jul 2022.
- Individual participant dataSharing planned: Yes. within six months after the trial complete
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Dysfunction, run by Han Yuan 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 4 inclusion and 8 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: finished, as of the sponsor's last update on 25 Jul 2022. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
the neuropsychological test battery to measure cognitive function (time frame: 1 day before surgery(baseline)). 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 25 Jul 2022.