NCT06466083

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).

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
165

participants targeted

Target at P50-P75 for all trials

Timeline
2mo left

Started Jan 2025

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress90%
Jan 2025Jul 2026

First Submitted

Initial submission to the registry

May 29, 2024

Completed
22 days until next milestone

First Posted

Study publicly available on registry

June 20, 2024

Completed
7 months until next milestone

Study Start

First participant enrolled

January 14, 2025

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2026

Last Updated

April 3, 2025

Status Verified

March 1, 2025

Enrollment Period

1.5 years

First QC Date

May 29, 2024

Last Update Submit

March 30, 2025

Conditions

Keywords

postoperative deliriumpostoperative neurocognitive disorderserum indexesspinal surgery

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (1)

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

Interventions

this is an observation study,no intervention

postoperative delirium(POD) and postoperative neurocognitive disorder(pNCD)

Eligibility Criteria

Age65 Years - 100 Years
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)
Sampling MethodProbability Sample
Study Population

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

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Xuanwu Hospital, Capital Medical University, Beijing, 100053

Beijing, China

RECRUITING

MeSH Terms

Conditions

Emergence Delirium

Condition Hierarchy (Ancestors)

DeliriumConfusionNeurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesPostoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsSigns and SymptomsNeurocognitive DisordersMental Disorders

Central Study Contacts

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
1 Year
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 29, 2024

First Posted

June 20, 2024

Study Start

January 14, 2025

Primary Completion (Estimated)

July 1, 2026

Study Completion (Estimated)

July 1, 2026

Last Updated

April 3, 2025

Record last verified: 2025-03

Data Sharing

IPD Sharing
Will not share

Locations