Efficiency of Donepezil in Elderly Patients for Prevention of POCD Dysfunction

December 28, 2020 updated by: RenJi Hospital

Efficiency of Donepezil in Elderly Patients Undergoing Orthopedic Surgery Due to Underlying Postoperative Cognitive Dysfunction, a Multicenter Randomized Controlled Trial

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.

Study Overview

Study Type

Interventional

Enrollment (Anticipated)

360

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

    • Shanghai
      • Shanghai, Shanghai, China, 200127
        • Recruiting
        • Renji Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

60 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Elder than 60 years old
  2. Speak Chinese Mandarin
  3. Scheduled to undergo hip or knee replacement surgery and lumbar spine surgery
  4. The operation time is more than 2 hours.
  5. Signed the informed consent
  6. American Society of Anesthesiologists (ASA) classification I-II

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. Patients with tumors or infections
  5. Unwillingness to comply with the protocol or procedures
  6. Can not communicate normally in Mandarin Chinese
  7. Existing bradycardiac arrhythmia (Heart rate <60 bpm for any reasons)
  8. Existing gastrointestinal ulcer
  9. Existing urinary incontinence
  10. Existing asthma or chronic obstructive pulmonary disease
  11. Postoperative admission to ICU
  12. Allergic to donepezil

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: PREVENTION
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: QUADRUPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Donepezil
Donepezil a cholinesterase inhibitor, 5mg(1 pill)/ day for 7 days Po, was administrated from the day before surgery.
PLACEBO_COMPARATOR: Control
Placebo, 1 pill/ day for 7 days Po, was administrated from the day before surgery.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
The incidence of POCD after the surgery.
Time Frame: up to 7 days
up to 7 days

Secondary Outcome Measures

Outcome Measure
Time Frame
The incidence of postoperative delirium after surgery.
Time Frame: 1 to 7 days after surgery
1 to 7 days after surgery
POCD incidence one month, six months and one year after surgery.
Time Frame: one month, six months and one year after surgery
one month, six months and one year after surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Investigators

  • Principal Investigator: Diansan Su, Department of Anesthesiology Renji Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

June 14, 2020

Primary Completion (ANTICIPATED)

December 1, 2021

Study Completion (ANTICIPATED)

December 1, 2022

Study Registration Dates

First Submitted

June 6, 2020

First Submitted That Met QC Criteria

June 8, 2020

First Posted (ACTUAL)

June 9, 2020

Study Record Updates

Last Update Posted (ACTUAL)

December 29, 2020

Last Update Submitted That Met QC Criteria

December 28, 2020

Last Verified

December 1, 2020

More Information

Terms related to this study

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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