Clinical trial NCT06466096: Correlation Analysis of POD and pNCD in Elderly Patients With Gastrointestinal Neoplasms
Official title: Correlation Analysis of Postoperative Delirium and Postoperative Neurocognitive Disorder in Elderly Patients With Gastrointestinal Neoplasms
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Postoperative Delirium
Postoperative Neurocognitive Disorder
Gastrointestinal Surgery
Keywords: postoperative delirium
postoperative neurocognitive disorder
serum indicators
gastrointestinal neoplasms surgery
Lead sponsor: Xuanwu Hospital, Beijing
Sponsor class: OTHER
First posted: 2024-06-20
Enrollment: 165
Sex: ALL
Minimum age (years): 65
Maximum age (years): 100
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients 65\~100 years of age who have undergone surgical anesthesia of gastrointestinal neoplasms

Brief 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).

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.

Eligibility criteria: 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.

Primary outcomes:
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
timeFrame: 2024.5.9-2026.6.1
Secondary outcomes:
Other outcomes:
Locations:
city: Beijing
country: China
facility: Xuanwu Hospital, Capital Medical University
Study officials:
References: