AnesthesiaPRECISIONNCT03081429
A Prospective Cohort Study of Perioperative Covert Stroke and Postoperative Cognitive Dysfunction
An observational study of Anesthesia and Covert Stroke, run by Beijing Tiantan Hospital at 2 sites in China.
Trial summary
With the development of population aging, the incidence of covert stroke gradually increased. Currently, there is still lack of prospective cohort study with large sample size on the relationship between perioperative covert stroke and postoperative cognitive outcomes. Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Anesthesia, Covert Stroke
- How many people
- 934 participants
- Where
- 2 sitesChina
- Study dates
- 23 May 2018to 30 Aug 2023
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The population will be selected from patients who schedule to receive elective noncardiac surgery in Beijing Tiantan Hospital and Chinese People's Liberation Army General Hospital.
Who may be able to join
- Eligible patients were aged ≥60 years and scheduled for elective non-cardiac surgery with general anesthesia, with or without concomitant regional analgesia. They were expected to have surgery lasting at least 2 hours of anesthesia and to stay in the hospital at least 2 days thereafter.
Who cannot join
- Patients have MRI contraindications, cannot complete the cognitive evaluation, undergo carotid artery surgery or refuse to sign informed consent will be excluded from the trial.
Trial locations and contacts
2 sites in 1 country.
China2 sites
Beijing TianTan Hospital
Beijing, 100070
Chinese People's Liberation Army General Hospital
Beijing
About this study
Official title: A Prospective Cohort Study of Perioperative Covert Stroke and Postoperative Cognitive Dysfunction in Elderly Patients Undergoing Noncardiac Surgery
With the development of population aging, the incidence of covert stroke gradually increased. Currently, there is still lack of prospective cohort study with large sample size on the relationship between perioperative covert stroke and postoperative cognitive outcomes. The investigators will perform a prospective cohort study. The aim of the study is to determine whether there is an association between perioperative covert stroke and postoperative cognitive outcomes in elderly patients undergoing noncardiac surgery.
- Conditions
- Anesthesia, Covert Stroke
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 |
|---|---|---|
| With stroke | Not described | |
| Without stroke | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
The incidence of perioperative stroke
Stroke is diagnosed by MRI
Measured: Postoperative 1-7 days
Secondary outcomes (6)
Postoperative cognitive function
Cognitive assessment will be conducted by trained research members who are blinded to the clinical diagnosis, treatment and MRI. The Mini-mental State Examination, Montreal cognitive assessment-basic, Mini-Mental State Examination telephone scales, Montreal Cognitive Assessment telephone scales, and Telephone Interview of Cognitive Status scale will be used to assess the cognitive function. Postoperative cognitive dysfunction is defined as at least 2 standard deviation reduction on the Mini-Mental State Examination telephone scales or Montreal Cognitive Assessment telephone scales or a Telephone Interview of Cognitive Status scale scores≤27.
Measured: 1 day before surgery; and 7 days, 3 months, 1 year after surgery
Postoperative delirium
The Confusion Assessment Method for the Intensive Care Unit scale (CAM-ICU) or 3 min diagnostic interview for CAM (3D-CAM) will be applied to assess delirium.
Measured: twice a day (from 8:00 to 10:00 and from 18:00 to 20:00) during the first postoperative 5 days
Recovery quality
The Modified Rankin Scale (mRS) and Lawton instrumental activities of daily living scale (IADL) will be applied to assess the recovery quality.
Measured: 1 day before surgery; and 7 days, 30 days, 3 months after surgery
The quality of life
The quality of life will be assessed with the EuroQol-5D (EQ-5D) scale.
Measured: 1 day before surgery; and 7 days, 30 days, 3 months after surgery
Depression state
Depression state will be assessed with the Geriatric Depression Scale, Generalized Anxiety Disorder-7 and Patient Health Questionnaire-9.
Measured: 1 day before surgery; and 7 days, 30 days, 3 months after surgery
The incidence of comorbidity.
The incidence of myocardial infarction, cardiac arrest, pulmonary embolism, sepsis, surgical site infection and persistent postoperative pain.
Measured: 30 days and 3 months after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Mar 2017
- Study start23 May 2018
- Primary completion30 Aug 2022
- Study completion30 Aug 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for AnesthesiaStudies of the same condition, open and under way.
- More trials run by Beijing Tiantan HospitalThe 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
- 934 participants (actual)
Sponsor and investigators
- Lead sponsor
- Beijing Tiantan Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Chinese PLA General Hospital
- Responsible party
- Principal investigator, Yuming Peng, Beijing Tiantan Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03081429
- Sponsor's protocol ID
- 2017-3-10
- Acronym
- PRECISION
- Status last verified
- Aug 2024
- First submitted
- 10 Mar 2017
- Last updated
- 12 Aug 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Cui Q, Wang D, Zeng M, Dong J, Jin H, Hu Z, Zhang Y, Peng Y, Han R. Association of postoperative covert stroke and cognitive dysfunction among elderly patients undergoing non-cardiac surgery: protocol for a prospective cohort study (PRECISION study). BMJ Open. 2020 Jan 6;10(1):e034657. doi: 10.1136/bmjopen-2019-034657.
PubMed 31911527
Study at a glance
From the registry record, last updated by the sponsor on 12 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Cohort Study of Perioperative Covert Stroke and Postoperative Cognitive Dysfunction in Elderly Patients Undergoing Noncardiac Surgery
- ClinicalTrials.gov ID
- NCT03081429
- Acronym / sponsor ID
- PRECISION / 2017-3-10
- Conditions
- Anesthesia, Covert Stroke
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 934 participants (actual)
- Lead sponsor
- Beijing Tiantan HospitalUniversity, hospital or other
- Collaborators
- Chinese PLA General Hospital
- Study start
- 23 May 2018 (actual)
- Primary completion
- 30 Aug 2022 (actual)
- Study completion
- 30 Aug 2023 (actual)
- First posted
- 16 Mar 2017 (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.
With the development of population aging, the incidence of covert stroke gradually increased. Currently, there is still lack of prospective cohort study with large sample size on the relationship between perioperative covert stroke and postoperative cognitive outcomes. The investigators will perform a prospective cohort study. The aim of the study is to determine whether there is an association between perioperative covert stroke and postoperative cognitive outcomes in elderly patients undergoing noncardiac surgery.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| With stroke | – | – |
| Without stroke | – | – |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The population will be selected from patients who schedule to receive elective noncardiac surgery in Beijing Tiantan Hospital and Chinese People's Liberation Army General Hospital.
Key inclusion criteria (1 listed)
- Eligible patients were aged ≥60 years and scheduled for elective non-cardiac surgery with general anesthesia, with or without concomitant regional analgesia. They were expected to have surgery lasting at least 2 hours of anesthesia and to stay in the hospital at least 2 days thereafter.
Key exclusion criteria (1 listed)
- Patients have MRI contraindications, cannot complete the cognitive evaluation, undergo carotid artery surgery or refuse to sign informed consent will be excluded from the trial.
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 incidence of perioperative stroke
Time frame: Postoperative 1-7 days
Stroke is diagnosed by MRI
6 secondary outcomes
Postoperative cognitive function
Time frame: 1 day before surgery; and 7 days, 3 months, 1 year after surgery
Postoperative delirium
Time frame: twice a day (from 8:00 to 10:00 and from 18:00 to 20:00) during the first postoperative 5 days
Recovery quality
Time frame: 1 day before surgery; and 7 days, 30 days, 3 months after surgery
The quality of life
Time frame: 1 day before surgery; and 7 days, 30 days, 3 months after surgery
Depression state
Time frame: 1 day before surgery; and 7 days, 30 days, 3 months after surgery
The incidence of comorbidity.
Time frame: 30 days and 3 months 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 12 Aug 2024.
- Derived from this study: PubMed 31911527Cui Q, Wang D, Zeng M, Dong J, Jin H, Hu Z, Zhang Y, Peng Y, Han R. Association of postoperative covert stroke and cognitive dysfunction among elderly patients undergoing non-cardiac surgery: protocol for a prospective cohort study (PRECISION study). BMJ Open. 2020 Jan 6;10(1):e034657. doi: 10.1136/bmjopen-2019-034657.
Related trials for Anesthesia
Not yet recruitingObservational study
"Comparison of Oxygen Reserve Index (ORI), End-Tidal Oxygen, and Time-Based Preoxygenation Targets With Arterial Blood Gas During Preoxygenation
Preoxygenation Adequacy Assessed by Oxygen Reserve Index, End-tidal Oxygen and Arterial Blood Gas
RecruitingObservational study
Comparison of Hemodynamic Responses During Anesthesia Induction Using Eleveld and Schnider
Spinal (Fusion) Surgery, Total Intravenous Anesthesia
Not yet recruiting
A Randomized Controlled SaCo-VLM Trial
General Anaesthesia Using Supraglotic Airway
Not yet recruiting
Bispectral Index-Guided Propofol Sedation During Endoscopic Retrograde Cholangiopancreatography
Deep Sedation, Endoscopic Retrograde Cholangiopancreatography
RecruitingPhase 4
Comparison of Hemodynamics and Respiratory Function Between Ciprofol and Propofol in Elderly Patients Undergoing Non-intubated General Anesthesia
Comparison of Hemodynamics and Respiratory Function Between Ciprofol and Propofol in Elderly Patients Undergoing Non-intubated General Anesthesia
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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Anesthesia and Covert Stroke, run by Beijing Tiantan Hospital at 2 sites 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 1 inclusion and 1 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 12 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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 incidence of perioperative stroke (time frame: Postoperative 1-7 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03081429, which also lists 1 linked publication.
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 12 Aug 2024.