AnesthesiaNCT05177159
Postoperative Delirium and Its Biomarkers in Elderly Patients Undergoing Non-cardiac and Non-neurosurgery.
An observational study of Anesthesia and Postoperative Delirium, run by Beijing Tiantan Hospital at 1 site in China.
Trial summary
Postoperative delirium (POD) is a common complication in elderly patients and is associated with negative clinical outcomes, such as prolonged hospitalizations, cognitive impairment, and higher mortality rate. Read more about this study
- Who is it for?
- Ages 60 to 85 years
- Conditions the study is for
- Anesthesia, Postoperative Delirium
- What is being tested?
- The regional cerebral oxygen saturation (rSO2), The glial fibrillary acidic protein (GFAP) and The brain-derived-neurotrophic factor (BDNF)
- How many people
- 417 participants
- Where
- 1 siteChina
- Study dates
- 10 Nov 2018to 30 Dec 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 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The population will be selected from patients who schedule to receive elective non-cardiac and non-neurological surgery in Beijing Tiantan Hospital.
Who may be able to join
- With American Society of Anesthesiologists (ASA) physical status Ⅱ-Ⅳ
- Undergo elective non-cardiac and non-neurological surgery receiving general anesthesia
- Operation time is expected to be longer than 2 hours
Who cannot join
- Clinical diagnosis of dementia
- Clinical diagnosis of cerebrovascular disorders
- Clinical diagnosis of heart failure
- Clinical diagnosis of liver failure
- Clinical diagnosis of renal failure
- Clinical diagnosis of traumatic brain injury
Show all 9Show fewer
- Alcohol abuse
- Can not complete the cognitive assessments
- Refuse to sign informed consent
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Beijing Tiantan Hospital
Beijing, Beijing Municipality, 100050
Yuming Peng
About this study
Official title: Postoperative Delirium and Its Biomarkers in Elderly Patients Undergoing Non-cardiac and Non-neurosurgery: a Prospective Cohort Study.
Postoperative delirium (POD) is a common complication in elderly patients and is associated with negative clinical outcomes, such as prolonged hospitalizations, cognitive impairment, and higher mortality rate. While the pathophysiology of delirium remains unknown, the cerebral hypoperfusion and neuroinflammatory response are considered to play an important role in the process of POD. The aim of the study is to determine the association between POD and biomarkers in elderly patients undergoing noncardiac and non-neurological surgery.
- Conditions
- Anesthesia, Postoperative Delirium
- Being tested
- The regional cerebral oxygen saturation (rSO2), The glial fibrillary acidic protein (GFAP), The brain-derived-neurotrophic factor (BDNF)
- Medical subject headings
- Emergence Delirium
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
The regional cerebral oxygen saturation (rSO2)Other
Measurement of rSO2 with non-invasive near-infrared light spectrum monitor. The average, left and right frontal regions absolute rSO2 values will be collected every 30 seconds during the whole surgery until postoperative 2 hours, and the mean values will be calculated. Absolute rSO2 value and AUT (area under the threshold) send beneath the absolute threshold limits of 40%, 50% and 20%, 30% under the baseline. AUT will be calculated based on this formula: AUT (present)=AUT (past)+(rSO2 threshold-rSO2 value)×sample rate
The glial fibrillary acidic protein (GFAP)Other
Venous blood sample will be collected and tested for plasma GFAP. The blood will be collected 10 minutes before anesthesia, 30 minutes after intubation, every hour during operation, 15 minutes after extubation, and at 10:00 AM in postoperative 1,3,5 days.
The brain-derived-neurotrophic factor (BDNF)Other
Venous blood sample will be collected and tested for plasma BDNF. The blood will be collected 10 minutes before anesthesia, 30 minutes after intubation, every hour during operation, 15 minutes after extubation, and at 10:00 AM in postoperative 1,3,5 days.
| Study group | Role | What they receive |
|---|---|---|
| Postoperative delirium | Not described Receives: Other: The regional cerebral oxygen saturation (rSO2); Other: The glial fibrillary acidic protein (GFAP); Other: The brain-derived-neurotrophic factor (BDNF) | |
| Non postoperative delirium | Not described Receives: Other: The regional cerebral oxygen saturation (rSO2); Other: The glial fibrillary acidic protein (GFAP); Other: The brain-derived-neurotrophic factor (BDNF) |
What is being measured
The primary outcome is the main question the study is designed to answer.
The incidence of postoperative delirium within postoperative 5 days
The postoperative delirium will be diagnosed if patients have fluctuation in mental status and attention and either thinking or consciousness in the past 24 hours as evidenced by fluctuation on Confusion Assessment Method-Intensive Care Unit (CAM-ICU) scale.
Measured: the incidence of delirum within postoperative 5 days.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jan 2022
- Study start10 Nov 2018
- Primary completion30 Dec 2023 (estimated)
- Study completion30 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- 417 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beijing Tiantan Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ruquan Han, Beijing Tiantan Hospital
- Investigators
- Ruquan Han, M.D., Ph.D, Principal investigator, Beijing Tiantan Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05177159
- Sponsor's protocol ID
- 2018-5-30
- Status last verified
- Feb 2023
- First submitted
- 4 Jun 2018
- Last updated
- 15 Feb 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Postoperative Delirium and Its Biomarkers in Elderly Patients Undergoing Non-cardiac and Non-neurosurgery: a Prospective Cohort Study.
- ClinicalTrials.gov ID
- NCT05177159
- Acronym / sponsor ID
- 2018-5-30
- Conditions
- Anesthesia, Postoperative Delirium
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 417 participants (estimated)
- Lead sponsor
- Beijing Tiantan HospitalUniversity, hospital or other
- Study start
- 10 Nov 2018 (actual)
- Primary completion
- 30 Dec 2023 (estimated)
- Study completion
- 30 Dec 2023 (estimated)
- First posted
- 4 Jan 2022 (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.
Postoperative delirium (POD) is a common complication in elderly patients and is associated with negative clinical outcomes, such as prolonged hospitalizations, cognitive impairment, and higher mortality rate. While the pathophysiology of delirium remains unknown, the cerebral hypoperfusion and neuroinflammatory response are considered to play an important role in the process of POD. The aim of the study is to determine the association between POD and biomarkers in elderly patients undergoing noncardiac and non-neurological surgery.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Postoperative delirium | – | Other: The regional cerebral oxygen saturation (rSO2), Other: The glial fibrillary acidic protein (GFAP), Other: The brain-derived-neurotrophic factor (BDNF) |
| Non postoperative delirium | – | Other: The regional cerebral oxygen saturation (rSO2), Other: The glial fibrillary acidic protein (GFAP), Other: The brain-derived-neurotrophic factor (BDNF) |
Who may qualify
- Ages
- 60 to 85 years
- 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 non-cardiac and non-neurological surgery in Beijing Tiantan Hospital.
Key inclusion criteria (3 listed)
- With American Society of Anesthesiologists (ASA) physical status Ⅱ-Ⅳ
- Undergo elective non-cardiac and non-neurological surgery receiving general anesthesia
- Operation time is expected to be longer than 2 hours
Key exclusion criteria (9 listed)
- Clinical diagnosis of dementia
- Clinical diagnosis of cerebrovascular disorders
- Clinical diagnosis of heart failure
- Clinical diagnosis of liver failure
- Clinical diagnosis of renal failure
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 |
|---|---|---|
| The regional cerebral oxygen saturation (rSO2)Measurement of rSO2 with non-invasive near-infrared light spectrum monitor. The average, left and right frontal regions absolute rSO2 values will be collected every 30 seconds during the whole surgery until postoperative 2 hours, and the mean values will be calculated. Absolute rSO2 value and AUT (area under the threshold) send beneath the absolute threshold limits of 40%, 50% and 20%, 30% under the baseline. AUT will be calculated based on this formula: AUT (present)=AUT (past)+(rSO2 threshold-rSO2 value)×sample rate | Other | Non postoperative delirium, Postoperative delirium |
| The glial fibrillary acidic protein (GFAP)Venous blood sample will be collected and tested for plasma GFAP. The blood will be collected 10 minutes before anesthesia, 30 minutes after intubation, every hour during operation, 15 minutes after extubation, and at 10:00 AM in postoperative 1,3,5 days. | Other | Non postoperative delirium, Postoperative delirium |
| The brain-derived-neurotrophic factor (BDNF)Venous blood sample will be collected and tested for plasma BDNF. The blood will be collected 10 minutes before anesthesia, 30 minutes after intubation, every hour during operation, 15 minutes after extubation, and at 10:00 AM in postoperative 1,3,5 days. | Other | Non postoperative delirium, Postoperative delirium |
Primary outcome
The incidence of postoperative delirium within postoperative 5 days
Time frame: the incidence of delirum within postoperative 5 days.
The postoperative delirium will be diagnosed if patients have fluctuation in mental status and attention and either thinking or consciousness in the past 24 hours as evidenced by fluctuation on Confusion Assessment Method-Intensive Care Unit (CAM-ICU) scale.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Feb 2023.
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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.
Ruquan Han, M.D., Ph.D principal investigator
Beijing Tiantan Hospital
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 Anesthesia and Postoperative Delirium, run by Beijing Tiantan Hospital 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 3 inclusion and 9 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 15 Feb 2023. 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 Zhengfang Hu, M.D., Ph.D (8610-67096658, huzhengfang78@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The incidence of postoperative delirium within postoperative 5 days (time frame: the incidence of delirum within postoperative 5 days.). 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 15 Feb 2023.