Correlation Analysis of POD and pNCD in Elderly Spinal Surgery Patients

Correlation Analysis of Postoperative Delirium and Postoperative Neurocognitive Disorder in Elderly Spinal Surgery Patients

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).

Study Overview

• Status: Recruiting
• Conditions: Postoperative Delirium; Spinal Surgery; Postoperative Neurocognitive Disorder
• Intervention / Treatment: Other: no intervention

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 Type: Observational
• Enrollment (Estimated): 165

Contacts and Locations

• Study Contact: Name: lei zhao; Phone Number: +8613811035886; Email: zhaoalei@sina.com
• Study Contact Backup: Name: ke cui; Phone Number: +8613671393294; Email: 15911031500@163.com

Study Locations

• China
  • Beijing, China
    • Recruiting
    • Xuanwu Hospital, Capital Medical University, Beijing, 100053
    • Contact: Lei Zhao, Doctor's; Phone Number: +8613811035886; Email: zhaoalei@sina.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

Patients 65~100 years of age who have undergone spinal surgical anesthesia

Description

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

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 serum indexes were compared

Other: no intervention; this is an observation study,no intervention

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	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.	2024.5.9-2026.5.1

Collaborators and Investigators

• Sponsor: Xuanwu Hospital, Beijing

Study record dates

Study Major Dates

• Study Start (Actual): January 14, 2025
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): July 1, 2026

Study Registration Dates

• First Submitted: May 29, 2024
• First Submitted That Met QC Criteria: June 13, 2024
• First Posted (Actual): June 20, 2024

Study Record Updates

• Last Update Posted (Actual): April 3, 2025
• Last Update Submitted That Met QC Criteria: March 30, 2025
• Last Verified: March 1, 2025

More Information

Terms related to this study

• Keywords: spinal surgery; postoperative delirium; postoperative neurocognitive disorder; serum indexes
• Additional Relevant MeSH Terms: Neurologic Manifestations; Nervous System Diseases; Mental Disorders; Postoperative Complications; Pathologic Processes; Confusion; Neurobehavioral Manifestations; Emergence Delirium; Delirium; Neurocognitive Disorders
• Other Study ID Numbers: 19880416

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No