Predictive Value of β2-microspheres for Postoperative Delirium

Postoperative Delirium Clinical Trial

Official title:

The Predictive Value of β2-microspheres for Postoperative Delirium in the Elderly After Orthopedic Surgery

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03130231
• Other study ID #: 199101026046
• Status: Completed
• Start date: October 1, 2015
• Est. completion date: December 30, 2017

Study information

• Verified date: December 2018
• Source: Zhongda Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 184
• Est. completion date: December 30, 2017
• Est. primary completion date: December 30, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 65 Years and older

Eligibility

Inclusion Criteria:

• =65 years old, American Standards Association?-?, undergoing orthopedic operations under spinal anesthesia

Exclusion Criteria:

• decline to participate

Related Conditions & MeSH terms

• Delirium
• Postoperative Delirium

Locations

Country	Name	City	State
China	Zhongda Hospital	Nanjing	Jiangsu

Sponsors (1)

Lead Sponsor	Collaborator
Zhongda Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	The levels of ß2-microspheres in plasma and cerebrospinal fluid	Before surgery, plasma and cerebrospinal fluid of the patients were collected to detect the levels of ß2-microspheres.	1 day