- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02817386
Study of Postoperative Delirium in Elderly People After Orthopedic Surgery
February 22, 2017 updated by: Mian Peng,MD, Zhongnan Hospital
microRNA and Delirium After Hip and Knee Fracture
The purpose of this study is to investigate the possible relationship of microRNA and postoperative delirium.
Study Overview
Detailed Description
Postoperative delirium is one of the most common postoperative complications in elderly patients.It has been shown that postoperative delirium has independent adverse effects on short and long-term mortality and morbidity, including poor functional recovery, postoperative cognitive dysfunction, deterioration in quality of life, and increased costs.
However, at the present time, postoperative delirium is a clinical phenomenon, and its neuropathogenesis remains unknown.
This gap in knowledge has become a barrier that limits further studies, including the development of potential interventions for postoperative delirium.
Study Type
Observational
Enrollment (Actual)
52
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
65 years and older (Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Sampling Method
Probability Sample
Study Population
A total of 60 adults who were scheduled to have elective total hip or knee replacement surgery at the Zhongnan Hospital were asked to participate in this study.
Description
Inclusion Criteria:
- 65 years old or older
- candidates for spinal anesthesia
- Non language communication barriers
Exclusion Criteria:
- past medical history of neurological and psychiatric diseases including AD, other forms of dementia, stroke, or psychosis;
- severe visual or hearing impairment;
- unwillingness to comply with the protocol or procedures.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
POD and Non-POD;
Trained clinical research assistants interviewed the patients on the first and second day post surgery.
The assessment of post deliriu (POD) was performed once per day between 8:00 AM to 10:00 AM.
Patient notes were not reviewed for episodes of delirium which could occur outside the time of assessment.
The clinical research assistants who performed the delirium assessments in this study had good training and went through quality control procedures.
We used state-of-the-art delirium detection methods, which tend to report a higher incidence of delirium.
The interview included the Confusion Assessment Method (CAM) and Memorial Delirium Assessment Scale (MDAS).
|
Trained clinical research assistants interviewed the patients on the first and second day post surgery.
The interview included the Confusion Assessment Method (CAM) and MDAS.
CAM is a diagnostic algorithm used to determine the presence or absence of delirium.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
The level of microRNA in cerebrospinal fluid and serum
Time Frame: through study completion, an average of 1 year
|
All of the participants had spinal anesthesia for the scheduled surgery.
Two milliliter of CSF was collected from a spinal needle by anesthesiologists during the spinal anesthesia before the administration of the local anesthetic.
Blood samples were collected from patients prior to spinal anesthesia.
|
through study completion, an average of 1 year
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Director: Mian Peng, MD, Wuhan University
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Xie Z, Swain CA, Ward SA, Zheng H, Dong Y, Sunder N, Burke DW, Escobar D, Zhang Y, Marcantonio ER. Preoperative cerebrospinal fluid beta-Amyloid/Tau ratio and postoperative delirium. Ann Clin Transl Neurol. 2014 May 1;1(5):319-328. doi: 10.1002/acn3.58.
- Dong R, Sun L, Lu Y, Yang X, Peng M, Zhang Z. NeurimmiRs and Postoperative Delirium in Elderly Patients Undergoing Total Hip/Knee Replacement: A Pilot Study. Front Aging Neurosci. 2017 Jun 23;9:200. doi: 10.3389/fnagi.2017.00200. eCollection 2017.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
March 1, 2015
Primary Completion (Actual)
January 1, 2016
Study Completion (Actual)
February 1, 2016
Study Registration Dates
First Submitted
June 22, 2016
First Submitted That Met QC Criteria
June 26, 2016
First Posted (Estimate)
June 29, 2016
Study Record Updates
Last Update Posted (Actual)
February 24, 2017
Last Update Submitted That Met QC Criteria
February 22, 2017
Last Verified
February 1, 2017
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2015002
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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