NCT02927522

Brief 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.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
550

participants targeted

Target at P75+ for phase_3

Timeline
Completed

Started Sep 2018

Typical duration for phase_3

Geographic Reach
1 country

1 active site

Status
unknown

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 5, 2016

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 7, 2016

Completed
1.9 years until next milestone

Study Start

First participant enrolled

September 1, 2018

Completed
3.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2021

Completed
Last Updated

January 30, 2020

Status Verified

January 1, 2020

Enrollment Period

3.3 years

First QC Date

October 5, 2016

Last Update Submit

January 27, 2020

Conditions

OsteoarthritisFemoral Head NecrosisRheumatoid Arthritis

Keywords

Postoperative Cognitive DysfunctionDonepezilHip replacementKnee replacementPostoperative delirium

Outcome Measures

Primary Outcomes (2)

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

    7 days after surgery or before leaving hospital

  • The incidence of postoperative delirium after surgery

    1 to 7 days after surgery

Secondary Outcomes (1)

  • POCD incidence 1 months after surgery

    1 months after surgery

Study Arms (2)

Control

PLACEBO COMPARATOR

Placebo was administrated

Drug: Placebo

Donepezil

EXPERIMENTAL

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

Drug: Donepezil

Interventions

DonepezilDRUG

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

Donepezil
PlaceboDRUG

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

Control

Eligibility Criteria

Age60 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • Existing cerebral disease, or have a history of neurological and psychiatric diseases including Alzheimer Disease, stroke, epilepsy and psychosis;
  • 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.
  • Can not communicated with Chinese Mandarin
  • Existing bradycardiac arrhythmia（Heart rate \<60 bpm for any reasons）
  • Existing gastrointestinal ulcer
  • Existing urinary incontinence
  • Existing asthma or chronic obstructive pulmonary disease
  • Allegory to Donepezil

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Shanghai Guanghua Hospital of Integrated Traditional Chinese and Western Medicine

Shanghai, Shanghai Municipality, 200052, China

RECRUITING

MeSH Terms

Conditions

OsteoarthritisArthritis, RheumatoidPostoperative Cognitive ComplicationsEmergence Delirium

Interventions

Donepezil

Condition Hierarchy (Ancestors)

ArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic DiseasesConnective Tissue DiseasesSkin and Connective Tissue DiseasesAutoimmune DiseasesImmune System DiseasesPostoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsCognitive DysfunctionCognition DisordersNeurocognitive DisordersMental DisordersDeliriumConfusionNeurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesSigns and Symptoms

Intervention Hierarchy (Ancestors)

IndansIndenesPolycyclic Aromatic HydrocarbonsHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsPiperidinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsPolycyclic Compounds

Study Officials

  • Diansan Su, M.D., Ph.D.

    RenJi Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Diansan Su, M.D., Ph.D.

CONTACT

+8618616514088diansansu@yahoo.com

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

October 5, 2016

First Posted

October 7, 2016

Study Start

September 1, 2018

Primary Completion

December 1, 2021

Study Completion

December 1, 2021

Last Updated

January 30, 2020

Record last verified: 2020-01

Locations

CN(1)