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NCT Number: NCT06466096

Correlation Analysis of POD and pNCD 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).

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Key information

Age range

65 year–100 year

Sex eligibility

All sexes

Study type

Observational

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients ≥65 years of age who have undergone surgical anesthesia of gastrointestinal neoplasms; Sign informed consent.

Exclusion criteria

  • 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.

Treatment and study plan

No intervention

Other

this is an observation study, no intervention

Primary outcomes

  1. 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).

Study contacts

Contact information is provided by the study sponsor or research team.

Lei Zhao, Doctor's

CONTACT

[email protected]

+8613811035886

Manke Luo, Bachelor's

CONTACT

[email protected]

+8615508707563

Sponsors and collaborators

Lead sponsor

Xuanwu Hospital, Beijing

Other

Registry information

Official study title

Correlation Analysis of Postoperative Delirium and Postoperative Neurocognitive Disorder in Elderly Patients With Gastrointestinal Neoplasms

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Jun 20, 2024
Registry last updated
Apr 3, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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