Predictive Value of β2-microspheres for Postoperative Delirium

NCT03130231 | Completed DMC

• 1 other identifier: 199101026046
• Study Type: observational
• Target: 184
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Postoperative Delirium

Keywords

Delirium β2-microspheres

Outcome Measures

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.

  4 days

Secondary Outcomes (1)

• The levels of β2-microspheres in plasma and cerebrospinal fluid

  1 day

Study Arms (2)

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.

Eligibility Criteria

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

Study Population

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

You may qualify if:

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

You may not qualify if:

• decline to participate

Sponsors & Collaborators

• Zhongda Hospital: lead

Study Sites (1)

Zhongda Hospital

Nanjing, Jiangsu, 210009, China

Location

Biospecimen

Retention: SAMPLES WITH DNA

plasma and cerebrospinal fluid

MeSH Terms

Conditions

Emergence Delirium

Condition Hierarchy (Ancestors)

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

Study Officials

• Jian-jun Yang

  Zhongda Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director, Department of Anesthesiology

Study Record Dates

• First Submitted: April 15, 2017
• First Posted: April 26, 2017
• Study Start: October 1, 2015
• Primary Completion: December 30, 2017
• Study Completion: December 30, 2017
• Last Updated: December 27, 2018

Record last verified: 2018-12

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)