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OpenTrials
Completed

NCT Number: NCT02063542

CSF Cholinergic Biomarkers and Postoperative Cognitive Change

Previous study demonstrated that the condition of central cholinergic nerve is important for the postoperative cognitive dysfunction. In present study investigators hypothesized that the acetylcholine concentration in the cerebral spinal fluid is associated to the postoperative cognitive changes in aged patients undergoing osteopathic surgery.

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Key information

Age range

60 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Renji hospital, School of Medicine, Shanghai Jiaotong University

Shanghai, Shanghai Municipality, 200127, China

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Elder than 60 years old
  • Spoke proficient Mandarin Chinese
  • Agree to undergoing spinal plus general anesthesia
  • Selected total knee replacement surgery

Exclusion criteria

  • Patients with neurological and/or psychiatric diseases, including AD, stroke and psychosis
  • Have contraindication for spinal anesthesia such as clotting disorder local infection in the puncture site
  • Existing cognitive impairment as evidenced by Mini-Mental State Examination scores below 24
  • Several audition or vision disorder
  • Unwillingness to comply with the protocol or procedures.

Treatment and study plan

Primary outcomes

  1. Short-term postoperative cognitive dysfunction rate

    Time frame: The day before surgery and 7 days after surgery (or before leave hospital)

  2. Concentration of Acetylcholine in CSF

    Time frame: During spinal anesthesia

  3. Concentration of choline acetyltransferase in CSF

    Time frame: During spinal anesthesia

  4. Concentration of acetylcholinesterase in CSF

    Time frame: During spinal anesthesia

Secondary outcomes

  1. Long-term postoperative cognitive dysfunction rate

    Time frame: Two months after surgery

Sponsors and collaborators

Lead sponsor

RenJi Hospital

Other

Registry information

Official study title

Cerebrospinal Fluid Cholinergic Biomarkers and Postoperative Cognitive Change in Aged Patients

Important dates

Study start
2014
Primary completion
2016
Study completion
2016
First posted
Feb 14, 2014
Registry last updated
May 22, 2019

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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