CClinicalTrials.gg
Status unknownNCT02927522DAPOCDUpdated Jan 30, 2020

Donepezil Attenuate Postoperative Cognitive Dysfunction

A Phase 3 interventional study of Donepezil and Placebo in Osteoarthritis, Femoral Head Necrosis and Rheumatoid Arthritis, sponsored by RenJi Hospital. Status unknown at 1 site in China. Open to participants aged 60 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2020-01-30.

Sponsored by RenJi Hospital · Phase 3, Interventional, and Prevention

The sponsor has not verified this record recently (last verified Jan 2020), so the status shown — last known as Recruiting — may be out of date.
Phase
Phase 3
Study type
Interventional
Enrollment
550
Allocation
Randomized
Ages
60 Years and older
Sex
All
01

Study summary

Postoperative cognitive dysfunction (POCD) occurs mainly in aged patients. POCD may increase the mortality and morbidity. However, the mechanism of POCD is not clear yet and no effective therapy method was proved. According to our previous study, the central cholinergic system impaired by the anesthesia and surgery play a very important role in the POCD and donepezil an acetylcholinesterase inhibitor can prevent the POCD after isoflurane anesthesia in aged mice. Donepezil is a commercial medicine used for the Alzheimer Disease, which is tolerable and has minimal adverse events. In present study a multi-center randomized case control study was conducted and we hypothesized that donepezil attenuate the POCD.

02

Conditions studied

  • Osteoarthritis
  • Femoral Head Necrosis
  • Rheumatoid Arthritis

Keywords

  • Postoperative Cognitive Dysfunction
  • Donepezil
  • Hip replacement
  • Knee replacement
  • Postoperative delirium
03

In context

Necrosis

477 studies on the registry are indexed under Necrosis; 54 are open to participants now.

This study's planned enrollment of 550 is above the median of 55 across 315 interventional studies indexed under Necrosis.

Browse Necrosis studies →

Lead sponsor

RenJi Hospital is the lead sponsor of 535 studies on the registry; 244 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
60 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  1. Elder than 60 years old
  2. Speak Chinese Mandarin
  3. Those who will undergo knee or hip replacement
  4. Signed the inform consent
  5. American Society of Anesthesiologists classification I to III

Exclusion criteria

Exclusion Criteria:

  1. Existing cerebral disease, or have a history of neurological and psychiatric diseases including Alzheimer Disease, stroke, epilepsy and psychosis;
  2. existing cognitive impairment as evidenced by Mini-Mental State Examination scores below 24;
  3. several audition or vision disorder;
  4. unwillingness to comply with the protocol or procedures.
  5. Can not communicated with Chinese Mandarin
  6. Existing bradycardiac arrhythmia(Heart rate \<60 bpm for any reasons)
  7. Existing gastrointestinal ulcer
  8. Existing urinary incontinence
  9. Existing asthma or chronic obstructive pulmonary disease
  10. Allegory to Donepezil
05

Study design

Phase
Phase 3
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
550 participants (estimated)

Study arms

  • Placebo comparator
    Control

    Placebo was administrated

    Drug: Placebo

  • Experimental
    Donepezil

    Donepezil (5mg/ day for 7 days) was administrated

    Drug: Donepezil

Interventions

  • DrugDonepezil

    Donepezil a cholinesterase inhibitor, 5mg(1 pill)/ day for 7 days Po, was administrated from the day before surgery.

  • DrugPlacebo

    Placebo, 1 pill/ day for 7 days Po, was administrated from the day before surgery.

06

What researchers measure

Primary outcomes

  1. The incidence of POCD 7 days(or before leaving hospital ) after surgery

    Time frame: 7 days after surgery or before leaving hospital

  2. The incidence of postoperative delirium after surgery

    Time frame: 1 to 7 days after surgery

Secondary outcomes

  1. POCD incidence 1 months after surgery

    Time frame: 1 months after surgery

07

Study locations

1 of 1 sites recruiting
  • Shanghai Guanghua Hospital of Integrated Traditional Chinese and Western Medicine
    Shanghai, Shanghai 200052, China
    • Xiaoxue Hu · Contact
    Recruiting
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 30, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT02927522
Lead sponsor
RenJi Hospital
Collaborators
Shanghai Guanghua Hospital of Integrated Traditional Chinese and Western Medicine
Responsible party
diansan su (Principal Investigator, RenJi Hospital) — Principal investigator
First posted
Oct 7, 2016
Start date
Sep 1, 2018
Primary completion
Dec 2021 (estimated)
Completion
Dec 2021 (estimated)
Last update
Jan 30, 2020

Study contacts

Diansan Su, M.D., Ph.D.
Contact
diansansu@yahoo.com
+8618616514088
Diansan Su, M.D., Ph.D.
principal investigator · RenJi Hospital

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Jan 2020. You cannot join it, but the record below documents what was studied.

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