NCT02063542

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
102

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jul 2014

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 8, 2014

Completed
6 days until next milestone

First Posted

Study publicly available on registry

February 14, 2014

Completed
5 months until next milestone

Study Start

First participant enrolled

July 1, 2014

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2016

Completed
Last Updated

May 22, 2019

Status Verified

May 1, 2019

Enrollment Period

2 years

First QC Date

February 8, 2014

Last Update Submit

May 20, 2019

Conditions

Necrosis of Femoral HeadKnee OsteoarthritisFracture of Lower Limb

Keywords

Postoperative cognitive changesAcetylcholine in CSFSurgery

Outcome Measures

Primary Outcomes (4)

  • Short-term postoperative cognitive dysfunction rate

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

  • Concentration of Acetylcholine in CSF

    During spinal anesthesia

  • Concentration of choline acetyltransferase in CSF

    During spinal anesthesia

  • Concentration of acetylcholinesterase in CSF

    During spinal anesthesia

Secondary Outcomes (1)

  • Long-term postoperative cognitive dysfunction rate

    Two months after surgery

Eligibility Criteria

Age60 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Aged patients undergoing total knee replacement surgery.

You may qualify if:

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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Renji hospital, School of Medicine, Shanghai Jiaotong University

Shanghai, Shanghai Municipality, 200127, China

Location

Biospecimen

Retention: SAMPLES WITH DNA

Cerebral spinal fluid

MeSH Terms

Conditions

Osteoarthritis, Knee

Condition Hierarchy (Ancestors)

OsteoarthritisArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic Diseases

Study Officials

  • Diansan Su, Dr.

    Renji Hospital, School of Medicine, Shanghai Jiaotong University

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

February 8, 2014

First Posted

February 14, 2014

Study Start

July 1, 2014

Primary Completion

July 1, 2016

Study Completion

July 1, 2016

Last Updated

May 22, 2019

Record last verified: 2019-05

Locations

CN(1)