search
Back to results

Donepezil Attenuate Postoperative Cognitive Dysfunction (DAPOCD)

Primary Purpose

Osteoarthritis, Femoral Head Necrosis, Rheumatoid Arthritis

Status
Unknown status
Phase
Phase 3
Locations
China
Study Type
Interventional
Intervention
Donepezil
Placebo
Sponsored by
RenJi Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Osteoarthritis focused on measuring Postoperative Cognitive Dysfunction, Donepezil, Hip replacement, Knee replacement, Postoperative delirium

Eligibility Criteria

60 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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:

  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

Sites / Locations

  • Shanghai Guanghua Hospital of Integrated Traditional Chinese and Western MedicineRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Experimental

Arm Label

Control

Donepezil

Arm Description

Placebo was administrated

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

POCD incidence 1 months after surgery

Full Information

First Posted
October 5, 2016
Last Updated
January 27, 2020
Sponsor
RenJi Hospital
Collaborators
Shanghai Guanghua Hospital of Integrated Traditional Chinese and Western Medicine
search

1. Study Identification

Unique Protocol Identification Number
NCT02927522
Brief Title
Donepezil Attenuate Postoperative Cognitive Dysfunction
Acronym
DAPOCD
Official Title
Donepezil Attenuate Postoperative Cognitive Dysfunction in Aged Patients- A Multi-center, Case Control, Randomized Clinical Trail
Study Type
Interventional

2. Study Status

Record Verification Date
January 2020
Overall Recruitment Status
Unknown status
Study Start Date
September 1, 2018 (Actual)
Primary Completion Date
December 2021 (Anticipated)
Study Completion Date
December 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
RenJi Hospital
Collaborators
Shanghai Guanghua Hospital of Integrated Traditional Chinese and Western Medicine

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteoarthritis, Femoral Head Necrosis, Rheumatoid Arthritis
Keywords
Postoperative Cognitive Dysfunction, Donepezil, Hip replacement, Knee replacement, Postoperative delirium

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
550 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Control
Arm Type
Placebo Comparator
Arm Description
Placebo was administrated
Arm Title
Donepezil
Arm Type
Experimental
Arm Description
Donepezil (5mg/ day for 7 days) was administrated
Intervention Type
Drug
Intervention Name(s)
Donepezil
Intervention Description
Donepezil a cholinesterase inhibitor, 5mg(1 pill)/ day for 7 days Po, was administrated from the day before surgery.
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo, 1 pill/ day for 7 days Po, was administrated from the day before surgery.
Primary Outcome Measure Information:
Title
The incidence of POCD 7 days(or before leaving hospital ) after surgery
Time Frame
7 days after surgery or before leaving hospital
Title
The incidence of postoperative delirium after surgery
Time Frame
1 to 7 days after surgery
Secondary Outcome Measure Information:
Title
POCD incidence 1 months after surgery
Time Frame
1 months after surgery

10. Eligibility

Sex
All
Minimum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Diansan Su, M.D., Ph.D.
Phone
+8618616514088
Email
diansansu@yahoo.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Diansan Su, M.D., Ph.D.
Organizational Affiliation
RenJi Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Shanghai Guanghua Hospital of Integrated Traditional Chinese and Western Medicine
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200052
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Xiaoxue Hu

12. IPD Sharing Statement

Learn more about this trial

Donepezil Attenuate Postoperative Cognitive Dysfunction

We'll reach out to this number within 24 hrs