Study of Postoperative Delirium in Elderly People After Orthopedic Surgery

Postoperative Delirium Clinical Trial

Official title:

microRNA and Delirium After Hip and Knee Fracture

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02817386
• Other study ID #: 2015002
• Status: Completed
• Phase: N/A
• First received: June 22, 2016
• Last updated: February 22, 2017
• Start date: March 2015
• Est. completion date: February 2016

Study information

• Verified date: February 2017
• Source: Zhongnan Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 52
• Est. completion date: February 2016
• Est. primary completion date: January 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 65 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Delirium
• Postoperative Delirium

Intervention

Other:
• 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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Zhongnan Hospital

References & Publications (1)

Xie Z, Swain CA, Ward SA, Zheng H, Dong Y, Sunder N, Burke DW, Escobar D, Zhang Y, Marcantonio ER. Preoperative cerebrospinal fluid ß-Amyloid/Tau ratio and postoperative delirium. Ann Clin Transl Neurol. 2014 May 1;1(5):319-328. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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