NCT02387541

Brief Summary

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

Trial Health

100
On Track

Trial Health Score

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

Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Mar 2012

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2012

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2013

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2014

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

March 6, 2015

Completed
7 days until next milestone

First Posted

Study publicly available on registry

March 13, 2015

Completed
Last Updated

May 3, 2016

Status Verified

March 1, 2015

Enrollment Period

1.8 years

First QC Date

March 6, 2015

Last Update Submit

May 1, 2016

Conditions

Perioperative Complications

Keywords

Postoperative cognitive dysfunction

Outcome Measures

Primary Outcomes (1)

  • Effects of operation on early postoperative cognitive function in elderly patients

    up to 7days postoperatively

Secondary Outcomes (1)

  • Postoperative cognitive dysfunction (POCD) was defined by Mini-Mental State Examination (MMSE) score

    up to 7days postoperatively

Other Outcomes (1)

  • serum concentration of inflammatory cytokine

    The blood samples were reserved before anesthesia induction and 24h after surgery

Eligibility Criteria

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

We included 96 ASA I or Ⅱ patients aged ≥65 years performed total knee replacement under general anesthesia.

You may qualify if:

  • aged ≥65 years;
  • ASA I or Ⅱ;
  • total knee replacement

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Biospecimen

Retention: SAMPLES WITHOUT DNA

Serum

MeSH Terms

Conditions

Postoperative Cognitive Complications

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsCognitive DysfunctionCognition DisordersNeurocognitive DisordersMental Disorders

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Target Duration
1 Week
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 6, 2015

First Posted

March 13, 2015

Study Start

March 1, 2012

Primary Completion

December 1, 2013

Study Completion

January 1, 2014

Last Updated

May 3, 2016

Record last verified: 2015-03