Correlation Analysis of POD and pNCD in Elderly Spinal Surgery Patients

Recruiting

• Conditions: Postoperative Delirium; Postoperative Neurocognitive Disorder; Spinal Surgery

• Registration Number: NCT06466083
• Lead Sponsor: Xuanwu Hospital, Beijing

Brief Summary

This study is a prospective cohort study to investigate the differences in serum indexes between elderly spinal surgery patients with postoperative delirium (POD) who either develop or do not develop long-term postoperative neurocognitive disorders (pNCD).

Detailed Description

To investigate the differences in serum indexes between elderly spinal surgery patients with postoperative delirium (POD) who either develop or do not develop long-term postoperative neurocognitive disorders (pNCD).

Neurocognitive function of the study participants was assessed within one week before surgery using the Montreal Cognitive Assessment (MoCA). Compare changes in serum indexes level before and after surgery. Under routine anesthetic management of the Department of Anesthesiology and Surgical Operations at Xuanwu Hospital, endotracheal intubation general anesthesia was performed. Within 7 days post-surgery, delirium assessment was conducted using the Confusion Assessment Method (CAM), classifying patients into POD and non-POD groups. Neurocognitive function assessments were conducted long-term after surgery for the POD group to determine the presence of pNCD, further dividing the POD group into pNCD and non-pNCD subgroups, followed by serum indexes.By comparing the changes of serum indexes before and after surgery between the pNCD and non-pNCD subgroups, exploring the correlation of POD and pNCD.

Study Timeline

• Study First Submitted: 2024-05-29
• Study First Submitted QC: 2024-06-13
• Study First Posted: 2024-06-20
• Study Start: 2025-01-14
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-30
• Last Update Posted: 2025-04-03
• Primary Completion: 2026-07-01
• Study Completion: 2026-07-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 165

Inclusion Criteria

• Patients ≥65 years of age who have undergone spinal surgery anesthesia; 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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
change in serum indexes between elderly spinal patients with postoperative delirium(POD) who either develop or do not develop postoperative neurocognitive disorders (pNCD) one month after surgery	2024.5.9-2026.5.1	Perioperative neurocognitive disorders (PND) represent one of the common complications of general anesthesia, posing serious hazards and currently being a hot topic and a challenging problem in international research. Recently, general anesthesia has led to a new breakthrough in the study of PND serum-related markers, such as brain-derived nutritional factors(BDNF)、C-reactive protein(CRP)、homocysteine(Hcy). This provides new perspectives for PND prevention, evaluation and furnishes theoretical grounds for enhancing the safety of clinical anesthesia and the quality of life for patients.

Trial Locations

Locations (1)

Xuanwu Hospital, Capital Medical University, Beijing, 100053; 🇨🇳 Beijing, China