Study of Postoperative Delirium in Elderly People After Orthopedic Surgery

NCT02817386 | Completed

• 1 other identifier: 2015002
• Study Type: observational
• Target: 52
• Locations: 0 countries
• Sites: N/A

Brief Summary

The purpose of this study is to investigate the possible relationship of microRNA and postoperative delirium.

Conditions

Postoperative Delirium

Keywords

postoperative delirium; microRNA

Outcome Measures

Primary Outcomes (1)

• The level of microRNA in cerebrospinal fluid and serum

  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

Study Arms (1)

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).

Other: interview

Interventions

interview OTHER

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.

POD and Non-POD;

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Older Adult (65+)
• 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.

You may qualify if:

• years old or older
• candidates for spinal anesthesia
• Non language communication barriers

You may not qualify if:

• 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.

Sponsors & Collaborators

• Zhongnan Hospital: lead

Related Publications (2)

• 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.

  PMID: 24860840 BACKGROUND

• 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.

  PMID: 28690539 DERIVED

MeSH Terms

Conditions

Emergence Delirium

Interventions

Interviews as Topic

Condition Hierarchy (Ancestors)

Delirium; Confusion; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Neurocognitive Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Officials

• Mian Peng, MD

  Zhongnan Hospital

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Target Duration: 2 Days
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: vice professor

Study Record Dates

• First Submitted: June 22, 2016
• First Posted: June 29, 2016
• Study Start: March 1, 2015
• Primary Completion: January 1, 2016
• Study Completion: February 1, 2016
• Last Updated: February 24, 2017

Record last verified: 2017-02

Data Sharing

• IPD Sharing: Will not share