Elderly Patients Undergoing Surgery During Perioperative Period

NCT07314762 | Recruiting

• 1 other identifier: SAHoWMU-CR2025-03-231
• Study Type: observational
• Target: 1,200
• Locations: 1 country
• Sites: 1

Brief Summary

The elderly patients have poorer overall conditions and have lower tolerance to trauma, anesthesia, and surgery. Therefore, the incidence of postoperative complications is relatively higher. In non-cardiac surgeries, approximately 20% of elderly patients experience postoperative complications, and the incidence of postoperative delirium (POD) is 23.8%. This may lead to prolonged hospital stays, increased hospital costs, and affect prognosis and even mortality. The investigators plan to conduct a prospective cohort study by systematically collecting biological samples and clinical information of elderly patients during the perioperative period to explore the possible risk factors and pathogenesis of postoperative delirium and postoperative complications in elderly surgical patients, and to construct a risk prediction model for postoperative complications.

Conditions

Postoperative Delirium (POD); Risk Prediction Model; Pathogenesis; Postoperative Complications; Elderly

Keywords

postoperative delirium; elderly; Cohort study

Outcome Measures

Primary Outcomes (1)

• Incidence of postoperative delirium (POD) within 7 days after surgery

  POD is diagnosed daily using the Three-Minute Diagnostic Confusion Assessment Method (3D-CAM).

  Preoperative, during the first 7 postoperative days

Secondary Outcomes (14)

• The types of postoperative delirium

  Preoperative, during the first 7 postoperative days

• The severity of postoperative delirium

  Preoperative, during the first 7 postoperative days

• The duration of postoperative delirium

  Preoperative, during the first 7 postoperative days

• Postoperative neurocognitive dysfunction

  preoperative baseline, within 7 days postoperatively, and at 1, 6, and 12 months postoperatively.

• Acute pain

  Preoperative and 3 days postoperative.

Study Arms (2)

Surgical patients aged 65 years or older

For the surgical group patients, questionnaires and scales measuring cognitive function, sleep quality, and quality of life were collected preoperatively, at 1-7 days post-operation, 30 days post-operation, and 1 year post-operation. During the operation, blood, cerebrospinal fluid, and other biological samples from the patients were also collected.

non-surgical subjects aged 65 years or older

For the non-surgical group patients, patients' basic information was collected, along with cognitive scales, sleep scales, and quality of life questionnaires.

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Surgical patients aged 65 or above or non-surgical subjects aged 65 or above

You may qualify if:

• \) Surgical patients aged 65 or above or non-surgical subjects aged 65 or above. 2) Agree to participate in this study and sign the informed consent form.

You may not qualify if:

• ）Refused to participate in the study.

Sponsors & Collaborators

• Second Affiliated Hospital of Wenzhou Medical University: lead

Study Sites (1)

The Second Affiliated Hospital and Yuying Children's Hospital of Wenzhou Medical University

Wenzhou, Zhejiang, 325000, China

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Blood and cerebrospinal fluid (CSF) samples (when available)

MeSH Terms

Conditions

Postoperative Complications; Emergence Delirium

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms; Delirium; Confusion; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Neurocognitive Disorders; Mental Disorders

Study Officials

• Ting Li, MD. PhD

  Department of Anaesthesiology and Perioperative Medicine, The Second Affiliated Hospital and Yuying Children's Hospital of Wenzhou Medical University, Wenzhou, Zhejiang, China

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ting Li MD. PhD

CONTACT

+86-135-8787-6896; liting1021@aliyun.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Year
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: December 11, 2025
• First Posted: January 2, 2026
• Study Start: December 30, 2023
• Primary Completion (Estimated): December 30, 2030
• Study Completion (Estimated): December 30, 2030
• Last Updated: April 1, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: Beginning 6 months after publication with no end date
• Access Criteria: De-identified participant data underlying the findings will be made available upon reasonable request. Proposals for data access should be directed to the corresponding author (liting1021@aliyun.com).

Locations

CN (1)