Study of Postoperative Delirium in Elderly People After Orthopedic Surgery

NCT ID: NCT02817386

Last Updated: 2017-02-24

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 52 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2015-03-31
• Study Completion Date: 2016-02-29

Brief Summary

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

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.

Conditions

Postoperative Delirium

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: PROSPECTIVE

Study Groups

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).

interview

Intervention Type: 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.

Interventions

interview

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.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

1. 65 years old or older

2. candidates for spinal anesthesia

3. Non language communication barriers

Exclusion Criteria

1. past medical history of neurological and psychiatric diseases including AD, other forms of dementia, stroke, or psychosis;

2. severe visual or hearing impairment;

3. unwillingness to comply with the protocol or procedures.

• Minimum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Zhongnan Hospital

OTHER

Sponsor Role: lead

Responsible Party

Mian Peng,MD

vice professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Mian Peng, MD

Role: STUDY_DIRECTOR

Zhongnan Hospital

References

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.

Reference Type: BACKGROUND

PMID: 24860840 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 28690539 (View on PubMed)

Other Identifiers

2015002

Identifier Type: -

Identifier Source: org_study_id