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CompletedNCT03130231Updated Dec 27, 2018

Predictive Value of β2-microspheres for Postoperative Delirium

An observational study in Postoperative Delirium, sponsored by Zhongda Hospital. Completed at 1 site in China. Open to participants aged 65 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2018-12-27.

Sponsored by Zhongda Hospital · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
184
Ages
65 Years and older
Sex
All
01

Study summary

This study evaluated the predictive value of β2-microspheres for postoperative delirium (POD) in the elderly after orthopedic surgery. For this purpose, the levels of β2-microspheres in plasma and cerebrospinal fluid were compared between the POD and non-POD groups.

Read the detailed description

In this study, plasma and cerebrospinal fluid of the patients were collected to detect the levels of β2-microspheres before operation. Also, the patients were interviewed one day before the surgery and on postoperative days 1-3 by the Confusion Assessment Method and then divided them into POD and non-POD groups. The aim of the present study was to assess whether higher levels of β2-microspheres could predict the occurrence of POD.

02

Conditions studied

  • Postoperative Delirium

Keywords

  • Delirium β2-microspheres
03

In context

Delirium

1,057 studies on the registry are indexed under Delirium; 238 are open to participants now.

This study's enrollment of 184 is close to the median of 200 across 418 observational studies indexed under Delirium.

Browse Delirium studies →

Lead sponsor

Zhongda Hospital is the lead sponsor of 101 studies on the registry; 40 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
65 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Probability sample

Study population

Patients aged ≥65 years undergoing orthopedic operations under spinal anesthesia were investigated.

Inclusion criteria

  • ≥65 years old, American Standards AssociationⅠ-Ⅲ, undergoing orthopedic operations under spinal anesthesia

Exclusion criteria

Exclusion Criteria:

  • decline to participate
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
184 participants (actual)
Patient registry
No
Biospecimen retention
Samples with dna

Groups and cohorts

  • POD group

    POD group refers to the patients who were diagnosed to be delirious by the Confusion Assessment Method.

  • Non-POD group

    Non-POD refered to the patients who did not become delirious by the Confusion Assessment Method.

06

What researchers measure

Primary outcomes

  1. The incidence of POD

    The patients were interviewed one day before the surgery and on postoperative days 1-3 by the Confusion Assessment Method and then divided them into POD and non-POD groups.

    Time frame: 4 days

Secondary outcomes

  1. The levels of β2-microspheres in plasma and cerebrospinal fluid

    Before surgery, plasma and cerebrospinal fluid of the patients were collected to detect the levels of β2-microspheres.

    Time frame: 1 day

07

Study locations

1 site
  • Zhongda Hospital
    Nanjing, Jiangsu 210009, China
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 27, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03130231
Lead sponsor
Zhongda Hospital
Responsible party
Jian-jun Yang (Director, Department of Anesthesiology, Zhongda Hospital) — Principal investigator
First posted
Apr 26, 2017
Start date
Oct 1, 2015
Primary completion
Dec 30, 2017
Completion
Dec 30, 2017
Last update
Dec 27, 2018

Study contacts

Jian-jun Yang
principal investigator · Zhongda Hospital

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Dec 2018. You cannot join it, but the record below documents what was studied.

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