Correlation Analysis of POD and pNCD in Elderly Patients With Gastrointestinal Neoplasms

NCT ID: NCT06466096

Last Updated: 2025-04-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

165 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-10-18

Study Completion Date

2026-07-01

Brief Summary

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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

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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.

Conditions

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Postoperative Delirium Postoperative Neurocognitive Disorder Gastrointestinal Surgery

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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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.

no intervention

Intervention Type OTHER

this is an observation study, no intervention

Interventions

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no intervention

this is an observation study, no intervention

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

65 Years

Maximum Eligible Age

100 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Xuanwu Hospital, Beijing

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Xuanwu Hospital, Capital Medical University

Beijing, , China

Site Status RECRUITING

Countries

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China

Central Contacts

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Lei Zhao, Doctor's

Role: CONTACT

+8613811035886

Manke Luo, Bachelor's

Role: CONTACT

+8615508707563

Facility Contacts

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Lei Zhao, Doctor's

Role: primary

+8613811035886

Manke Luo, Bachelor's

Role: backup

+8615508707563

Other Identifiers

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27961988

Identifier Type: -

Identifier Source: org_study_id

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