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Completed

NCT Number: NCT02817386

Study of Postoperative Delirium in Elderly People After Orthopedic Surgery

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

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Primary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

Zhongnan Hospital

Other

Registry information

Official study title

microRNA and Delirium After Hip and Knee Fracture

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
Jun 29, 2016
Registry last updated
Feb 24, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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