Effects of Total Knee Replacement on Early Postoperative Cognitive Function in Elderly Patients

Perioperative Complications Clinical Trial

— POCD  

Official title:

Effects of Total Knee Replacement on Early Postoperative Cognitive Function in Elderly Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02387541
• Other study ID #: NZ10145
• Status: Completed
• Phase: N/A
• First received: March 6, 2015
• Last updated: May 1, 2016
• Start date: March 2012
• Est. completion date: January 2014

Study information

• Verified date: March 2015
• Source: General Hospital of Ningxia Medical University
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Ministry of Science and Technology
• Study type: Observational [Patient Registry]

Clinical Trial Summary

To investigate the effects of total knee replacement is harmful to Postoperative cognitive dysfunction

Description:

Postoperative cognitive dysfunction (POCD) is reported to occur after major surgery in elderly patients. They may especially experience problems in the weeks and months after surgery. Recent studies vary greatly in methods of evaluation and diagnosis of POCD, and the pathogenic mechanisms are still unclear. The investigators evaluated a large uniform cohort of elderly patients in a standardized approach after total knee replacement.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: January 2014
• Est. primary completion date: December 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 65 Years and older

Eligibility

Inclusion Criteria:

• aged =65 years;

• ASA I or ?;

• total knee replacement

Exclusion Criteria:

• Mini Mental State Examination [MMSE] score too low.

• Parkinson or other neurological disease causing functional impairment.

• Patients with a history of alcohol abuse (=35 U per week) or daily use of anxiolytics were also excluded, as well as those with severe hearing or visual impairment.

Study Design

Observational Model: Case Control, Time Perspective: Prospective

Related Conditions & MeSH terms

• Perioperative Complications

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
General Hospital of Ningxia Medical University

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	serum concentration of inflammatory cytokine	The blood samples were reserved before anesthesia induction and 24h after surgery for detecting the concentrations of IL-1, IL-6, and IL-10 by enzyme-linked immunosorbent assay (ELISA).	The blood samples were reserved before anesthesia induction and 24h after surgery	Yes
Primary	Effects of operation on early postoperative cognitive function in elderly patients		up to 7days postoperatively	Yes
Secondary	Postoperative cognitive dysfunction (POCD) was defined by Mini-Mental State Examination (MMSE) score		up to 7days postoperatively	Yes