CSF Cholinergic Biomarkers and Postoperative Cognitive Change

May 20, 2019 updated by: diansan su, RenJi Hospital

Cerebrospinal Fluid Cholinergic Biomarkers and Postoperative Cognitive Change in Aged Patients

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.

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

102

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Shanghai
      • Shanghai, Shanghai, China, 200127
        • Renji Hospital, School of Medicine, Shanghai Jiaotong University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

60 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Aged patients undergoing total knee replacement surgery.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Short-term postoperative cognitive dysfunction rate
Time Frame: The day before surgery and 7 days after surgery (or before leave hospital)
The day before surgery and 7 days after surgery (or before leave hospital)
Concentration of Acetylcholine in CSF
Time Frame: During spinal anesthesia
During spinal anesthesia
Concentration of choline acetyltransferase in CSF
Time Frame: During spinal anesthesia
During spinal anesthesia
Concentration of acetylcholinesterase in CSF
Time Frame: During spinal anesthesia
During spinal anesthesia

Secondary Outcome Measures

Outcome Measure
Time Frame
Long-term postoperative cognitive dysfunction rate
Time Frame: Two months after surgery
Two months after surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

RenJi Hospital

Investigators

  • Study Chair: Diansan Su, Dr., Renji Hospital, School of Medicine, Shanghai Jiaotong University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 1, 2014

Primary Completion (Actual)

July 1, 2016

Study Completion (Actual)

July 1, 2016

Study Registration Dates

First Submitted

February 8, 2014

First Submitted That Met QC Criteria

February 12, 2014

First Posted (Estimate)

February 14, 2014

Study Record Updates

Last Update Posted (Actual)

May 22, 2019

Last Update Submitted That Met QC Criteria

May 20, 2019

Last Verified

May 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ACHandPOCD

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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