Perioperative ComplicationsPOCDNCT02387541
Effects of Total Knee Replacement on Early Postoperative Cognitive Function in Elderly Patients
An observational study of Perioperative Complications, run by General Hospital of Ningxia Medical University.
Trial summary
To investigate the effects of total knee replacement is harmful to Postoperative cognitive dysfunction Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Perioperative Complications
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- Mar 2012to Jan 2014
- How long will I take part?
- 1 Week
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Study population: We included 96 ASA I or Ⅱ patients aged ≥65 years performed total knee replacement under general anesthesia.
Who may be able to join
- aged ≥65 years;
- ASA I or Ⅱ;
- total knee replacement
Who cannot join
- 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.
About this study
To investigate the effects of total knee replacement is harmful to Postoperative cognitive dysfunction
Read the detailed 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.
- Conditions
- Perioperative Complications
- Keywords
- Postoperative cognitive dysfunction
- Medical subject headings
- Postoperative Cognitive Complications
What is being measured
The primary outcome is the main question the study is designed to answer.
Effects of operation on early postoperative cognitive function in elderly patients
Measured: up to 7days postoperatively
Secondary outcomes (1)
Postoperative cognitive dysfunction (POCD) was defined by Mini-Mental State Examination (MMSE) score
Measured: up to 7days postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Mar 2015 (estimated)
- Study startMar 2012
- Primary completionDec 2013
- Study completionJan 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Perioperative ComplicationsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 100 participants (actual)
- Target duration
- 1 Week
Sponsor and investigators
- Lead sponsor
- General Hospital of Ningxia Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02387541
- Sponsor's protocol ID
- NZ10145
- Acronym
- POCD
- Status last verified
- Mar 2015
- First submitted
- 6 Mar 2015
- Last updated
- 3 May 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 3 May 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Total Knee Replacement on Early Postoperative Cognitive Function in Elderly Patients
- ClinicalTrials.gov ID
- NCT02387541
- Acronym / sponsor ID
- POCD / NZ10145
- Conditions
- Perioperative Complications
- Keywords
- Postoperative cognitive dysfunction
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- General Hospital of Ningxia Medical UniversityUniversity, hospital or other
- Study start
- Mar 2012
- Primary completion
- Dec 2013 (actual)
- Study completion
- Jan 2014 (actual)
- First posted
- 13 Mar 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To investigate the effects of total knee replacement is harmful to Postoperative cognitive dysfunction
Detailed 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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Target follow-up
- 1 Week
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
- Study population
- We included 96 ASA I or Ⅱ patients aged ≥65 years performed total knee replacement under general anesthesia.
Key inclusion criteria (3 listed)
- aged ≥65 years;
- ASA I or Ⅱ;
- total knee replacement
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Effects of operation on early postoperative cognitive function in elderly patients
Time frame: up to 7days postoperatively
1 secondary outcome
Postoperative cognitive dysfunction (POCD) was defined by Mini-Mental State Examination (MMSE) score
Time frame: up to 7days postoperatively
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 May 2016.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Perioperative Complications, run by General Hospital of Ningxia Medical University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 May 2016. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Effects of operation on early postoperative cognitive function in elderly patients (time frame: up to 7days postoperatively). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 May 2016.