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NCT02063542 Clinical Trial

CSF Cholinergic Biomarkers and Postoperative Cognitive Change

Knee Osteoarthritis Clinical Trial

Official title:
Cerebrospinal Fluid Cholinergic Biomarkers and Postoperative Cognitive Change in Aged Patients

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT02063542
Other study ID # ACHandPOCD
Secondary ID
Status Completed
Phase
First received
Last updated
Start date July 2014
Est. completion date July 2016

Study information
Verified date May 2019
Source RenJi Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 102
Est. completion date July 2016
Est. primary completion date July 2016
Accepts healthy volunteers No
Gender All
Age group 60 Years and older
Eligibility 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 Design

Related Conditions & MeSH terms

Locations
Country Name City State
China Renji hospital, School of Medicine, Shanghai Jiaotong University Shanghai Shanghai

Sponsors (1)
Lead Sponsor Collaborator
RenJi Hospital

Country where clinical trial is conducted

China, 

Outcome
Type Measure Description Time frame Safety issue
Primary Short-term postoperative cognitive dysfunction rate The day before surgery and 7 days after surgery (or before leave hospital)
Primary Concentration of Acetylcholine in CSF During spinal anesthesia
Primary Concentration of choline acetyltransferase in CSF During spinal anesthesia
Primary Concentration of acetylcholinesterase in CSF During spinal anesthesia
Secondary Long-term postoperative cognitive dysfunction rate Two months after surgery
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