Clincosm LogoSign in Get a demo

CSF Cholinergic Biomarkers and Postoperative Cognitive Change

Sponsor
RenJi Hospital (Other)
Overall Status
Completed
CT.gov ID
NCT02063542
Collaborator
(none)
102
Enrollment
1
Location
24
Actual Duration (Months)
4.2
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    102 participants
    Observational Model:
    Case-Only
    Time Perspective:
    Prospective
    Official Title:
    Cerebrospinal Fluid Cholinergic Biomarkers and Postoperative Cognitive Change in Aged Patients
    Actual Study Start Date :
    Jul 1, 2014
    Actual Primary Completion Date :
    Jul 1, 2016
    Actual Study Completion Date :
    Jul 1, 2016

    Outcome Measures

    Primary Outcome Measures

    1. Short-term postoperative cognitive dysfunction rate [The day before surgery and 7 days after surgery (or before leave hospital)]

    2. Concentration of Acetylcholine in CSF [During spinal anesthesia]

    3. Concentration of choline acetyltransferase in CSF [During spinal anesthesia]

    4. Concentration of acetylcholinesterase in CSF [During spinal anesthesia]

    Secondary Outcome Measures

    1. Long-term postoperative cognitive dysfunction rate [Two months after surgery]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    60 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Renji hospital, School of Medicine, Shanghai Jiaotong University Shanghai Shanghai China 200127

    Sponsors and Collaborators

    • RenJi Hospital

    Investigators

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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    diansan su, Principal Investigator, RenJi Hospital
    ClinicalTrials.gov Identifier:
    NCT02063542
    Other Study ID Numbers:
    • ACHandPOCD
    First Posted:
    Feb 14, 2014
    Last Update Posted:
    May 22, 2019
    Last Verified:
    May 1, 2019
    Keywords provided by diansan su, Principal Investigator, RenJi Hospital
    Postoperative cognitive changes
    Acetylcholine in CSF
    Surgery
    Additional relevant MeSH terms:
    Osteoarthritis, Knee
    Necrosis

    Study Results

    No Results Posted as of May 22, 2019