Postoperative DeliriumNCT06466096
Correlation Analysis of POD and pNCD in Elderly Patients With Gastrointestinal Neoplasms
An observational study of Postoperative Delirium and Postoperative Neurocognitive Disorder, run by Xuanwu Hospital, Beijing at 1 site in China.
Trial summary
This is a prospective cohort study to explore the differences of serum indicators between elderly gastrointestinal neoplasms patients with postoperative delirium (POD) who either develop or do not develop long-term postoperative neurocognitive disorders (pNCD). Read more about this study
- Who is it for?
- Ages 65 to 100 years
- Conditions the study is for
- Postoperative Delirium, Postoperative Neurocognitive Disorder, Gastrointestinal Surgery
- How many people
- 165 participants
- Where
- 1 siteChina
- Study dates
- 18 Oct 2024to 1 Jul 2026
- How long will I take part?
- 1 Year
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 65 to 100 years
- All sexes
- No healthy volunteers
- Older adult
Study population: Patients 65~100 years of age who have undergone surgical anesthesia of gastrointestinal neoplasms
Who may be able to join
- Patients ≥65 years of age who have undergone surgical anesthesia of gastrointestinal neoplasms; Sign informed consent.
Who cannot join
- Inability to complete cognitive function assessment; Illiteracy, hearing impairment or visual impairment; He has a history of epilepsy, depression, schizophrenia, Alzheimer's disease and other psychiatric and neurological diseases.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Xuanwu Hospital, Capital Medical University
Beijing, 100053
Lei Zhao, Doctor's, +8613811035886, zhaoalei@sina.com
Manke Luo, Bachelor's, +8615508707563, uni1586830032@163.com
About this study
Official title: Correlation Analysis of Postoperative Delirium and Postoperative Neurocognitive Disorder in Elderly Patients With Gastrointestinal Neoplasms
This is a prospective cohort study to explore the differences of serum indicators between elderly gastrointestinal neoplasms patients with postoperative delirium (POD) who either develop or do not develop long-term postoperative neurocognitive disorders (pNCD).
Read the detailed description
The purpose of this study is to explore the differences of serum indicators between elderly gastrointestinal neoplasms patients with postoperative delirium (POD) who either develop or do not develop long-term postoperative neurocognitive disorders (pNCD).
Elderly gastrointestinal neoplasms patients aged 65 and above, undergoing surgical operations at Xuanwu Hospital, Capital Medical University, were selected. The serum indicators of all patients were measured before surgery, and neurocognitive function of all patients was assessed using the Montreal Cognitive Assessment (MoCA) within 1 week before surgery. General patient data such as sex, age, comorbidities, BMI, ASA classification, and MoCA scores were collected. Under routine anesthetic management of the Department of Anesthesiology and Surgical Operations at Xuanwu Hospital, endotracheal intubation general anesthesia was performed. Intraoperative monitoring included heart rate, blood pressure, pulse oximetry, and body temperature, with surgery and anesthesia times, and fluid balance recorded. The serum indicators of all patients were measured after surgery. Within 7 days post-surgery, delirium assessment was conducted using the Confusion Assessment Method (CAM), classifying patients into POD and non-POD groups. For the patients in the POD group, neurocognitive function was assessed at a period of time after surgery to determine the presence of pNCD, further dividing the POD group into pNCD and non-pNCD subgroups. The correlation between POD and pNCD was explored by comparing the changes of serum indicators before and after surgery in the pNCD and non-pNCD subgroups.
- Being tested
- no intervention
- Keywords
- postoperative delirium, postoperative neurocognitive disorder, serum indicators, gastrointestinal neoplasms surgery
- Medical subject headings
- Emergence Delirium
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
no interventionOther
this is an observation study, no intervention
| Study group | Role | What they receive |
|---|---|---|
| postoperative delirium(POD) and postoperative neurocognitive disorder(pNCD) | Delirium (CAM scale ) was assessed 7 days after surgery and divided into POD and non-POD groups; one of the above scenarios indicated postoperative delirium;The patients in the POD group were evaluated for cognitive function at 1 month and 12 months after surgery to determine whether pNCD occurred. The patients in the POD group were further divided into pNCD subgroup and non-PNCD subgroup, and the changes of serum indicators before and after surgery in the pNCD and non-pNCD subgroups were compared. Receives: Other: no intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
the changes of blood biomarkers before and after surgery between elderly gastrointestinal neoplasms patients with postoperative delirium (POD) who either develop or do not develop postoperative neurocognitive disorders (pNCD) one month after surgery
Perioperative changes in blood-based biomarkers can reflect the pathophysiological processes of diseases. Current studies indicate that the perioperative levels of blood-based biomarkers may be associated with postoperative neurocognitive disorders in elderly patients. These blood-based biomarkers may provide novel avenues for the early diagnosis, prevention, and improvement of outcomes in elderly patients with postoperative neurocognitive disorders.
The procedures are as follows:
Neurocognitive function assessments were conducted on the enrolled patients within one week before surgery, one month after surgery, and twelve months after surgery, respectively. Whether the patients developed postoperative delirium was evaluated within seven days after surgery. Venous blood was drawn before surgery and within three days after surgery to detect the levels of brain-derived neurotrophic factor (BDNF), high-sensitivity C-reactive protein (hs-CRP), and homocysteine (Hcy).
Measured: 2024.5.9-2026.6.1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jun 2024
- Study start18 Oct 2024
- Primary completion1 Jul 2026 (estimated)
- Study completion1 Jul 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postoperative DeliriumStudies of the same condition, open and under way.
- More trials run by Xuanwu Hospital, BeijingThe 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
- 165 participants (estimated)
- Target duration
- 1 Year
Sponsor and investigators
- Lead sponsor
- Xuanwu Hospital, Beijing
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06466096
- Sponsor's protocol ID
- 27961988
- Status last verified
- Mar 2025
- First submitted
- 3 Jun 2024
- Last updated
- 3 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Correlation Analysis of Postoperative Delirium and Postoperative Neurocognitive Disorder in Elderly Patients With Gastrointestinal Neoplasms
- ClinicalTrials.gov ID
- NCT06466096
- Acronym / sponsor ID
- 27961988
- Keywords
- postoperative delirium, postoperative neurocognitive disorder, serum indicators, gastrointestinal neoplasms surgery
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 165 participants (estimated)
- Lead sponsor
- Xuanwu Hospital, BeijingUniversity, hospital or other
- Study start
- 18 Oct 2024 (actual)
- Primary completion
- 1 Jul 2026 (estimated)
- Study completion
- 1 Jul 2026 (estimated)
- First posted
- 20 Jun 2024 (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.
This is a prospective cohort study to explore the differences of serum indicators between elderly gastrointestinal neoplasms patients with postoperative delirium (POD) who either develop or do not develop long-term postoperative neurocognitive disorders (pNCD).
Detailed description
The purpose of this study is to explore the differences of serum indicators between elderly gastrointestinal neoplasms patients with postoperative delirium (POD) who either develop or do not develop long-term postoperative neurocognitive disorders (pNCD).
Elderly gastrointestinal neoplasms patients aged 65 and above, undergoing surgical operations at Xuanwu Hospital, Capital Medical University, were selected. The serum indicators of all patients were measured before surgery, and neurocognitive function of all patients was assessed using the Montreal Cognitive Assessment (MoCA) within 1 week before surgery. General patient data such as sex, age, comorbidities, BMI, ASA classification, and MoCA scores were collected. Under routine anesthetic management of the Department of Anesthesiology and Surgical Operations at Xuanwu Hospital, endotracheal intubation general anesthesia was performed. Intraoperative monitoring included heart rate, blood pressure, pulse oximetry, and body temperature, with surgery and anesthesia times, and fluid balance recorded. The serum indicators of all patients were measured after surgery. Within 7 days post-surgery, delirium assessment was conducted using the Confusion Assessment Method (CAM), classifying patients into POD and non-POD groups. For the patients in the POD group, neurocognitive function was assessed at a period of time after surgery to determine the presence of pNCD, further dividing the POD group into pNCD and non-pNCD subgroups. The correlation between POD and pNCD was explored by comparing the changes of serum indicators before and after surgery in the pNCD and non-pNCD subgroups.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Year
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| postoperative delirium(POD) and postoperative neurocognitive disorder(pNCD) | – | Other: no interventionDelirium (CAM scale ) was assessed 7 days after surgery and divided into POD and non-POD groups; one of the above scenarios indicated postoperative delirium;The patients in the POD group were evaluated for cognitive function at 1 month and 12 months after surgery to determine whether pNCD occurred. The patients in the POD group were further divided into pNCD subgroup and non-PNCD subgroup, and the changes of serum indicators before and after surgery in the pNCD and non-pNCD subgroups were compared. |
Who may qualify
- Ages
- 65 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
- Study population
- Patients 65~100 years of age who have undergone surgical anesthesia of gastrointestinal neoplasms
Key inclusion criteria (1 listed)
- Patients ≥65 years of age who have undergone surgical anesthesia of gastrointestinal neoplasms; Sign informed consent.
Key exclusion criteria (1 listed)
- Inability to complete cognitive function assessment; Illiteracy, hearing impairment or visual impairment; He has a history of epilepsy, depression, schizophrenia, Alzheimer's disease and other psychiatric and neurological diseases.
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 |
|---|---|---|
| no interventionthis is an observation study, no intervention | Other | postoperative delirium(POD) and postoperative neurocognitive disorder(pNCD) |
Primary outcome
the changes of blood biomarkers before and after surgery between elderly gastrointestinal neoplasms patients with postoperative delirium (POD) who either develop or do not develop postoperative neurocognitive disorders (pNCD) one month after surgery
Time frame: 2024.5.9-2026.6.1
Perioperative changes in blood-based biomarkers can reflect the pathophysiological processes of diseases. Current studies indicate that the perioperative levels of blood-based biomarkers may be associated with postoperative neurocognitive disorders in elderly patients. These blood-based biomarkers may provide novel avenues for the early diagnosis, prevention, and improvement of outcomes in elderly patients with postoperative neurocognitive disorders. The procedures are as follows: Neurocognitive function assessments were conducted on the enrolled patients within one week before surgery, one month after surgery, and twelve months after surgery, respectively. Whether the patients developed postoperative delirium was evaluated within seven days after surgery. Venous blood was drawn before surgery and within three days after surgery to detect the levels of brain-derived neurotrophic factor (BDNF), high-sensitivity C-reactive protein (hs-CRP), and homocysteine (Hcy).
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Apr 2025.
- Individual participant dataSharing planned: No
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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.
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 Delirium and Postoperative Neurocognitive Disorder, run by Xuanwu Hospital, Beijing 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 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: looking for participants now, as of the sponsor's last update on 3 Apr 2025. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Lei Zhao, Doctor's (+8613811035886, zhaoalei@sina.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
the changes of blood biomarkers before and after surgery between elderly gastrointestinal neoplasms patients with postoperative delirium (POD) who either develop or do not develop postoperative neurocognitive disorders (pNCD) one month after surgery (time frame: 2024.5.9-2026.6.1). 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 3 Apr 2025.