Donepezil Attenuate Postoperative Cognitive Dysfunction (DAPOCD)

Donepezil Attenuate Postoperative Cognitive Dysfunction in Aged Patients- A Multi-center, Case Control, Randomized Clinical Trail

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

• Status: Unknown
• Conditions: Osteoarthritis; Rheumatoid Arthritis; Femoral Head Necrosis
• Intervention / Treatment: Drug: Placebo; Drug: Donepezil

• Study Type: Interventional
• Enrollment (Anticipated): 550
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: Diansan Su, M.D., Ph.D.; Phone Number: +8618616514088; Email: diansansu@yahoo.com

Study Locations

• China
  • Shanghai
    • Shanghai, Shanghai, China, 200052
      • Recruiting
      • Shanghai Guanghua Hospital of Integrated Traditional Chinese and Western Medicine
      • Contact: Xiaoxue Hu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 60 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

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

Outcome Measure	Time Frame
POCD incidence 1 months after surgery	1 months after surgery

Collaborators and Investigators

• Sponsor: RenJi Hospital
• Collaborators: Shanghai Guanghua Hospital of Integrated Traditional Chinese and Western Medicine
• Investigators: Principal Investigator: Diansan Su, M.D., Ph.D., Renji Hospital

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2018
• Primary Completion (Anticipated): December 1, 2021
• Study Completion (Anticipated): December 1, 2021

Study Registration Dates

• First Submitted: October 5, 2016
• First Submitted That Met QC Criteria: October 5, 2016
• First Posted (Estimate): October 7, 2016

Study Record Updates

• Last Update Posted (Actual): January 30, 2020
• Last Update Submitted That Met QC Criteria: January 27, 2020
• Last Verified: January 1, 2020

More Information

Terms related to this study

• Keywords: Donepezil; Hip replacement; Knee replacement; Postoperative delirium; Postoperative Cognitive Dysfunction
• Additional Relevant MeSH Terms: Mental Disorders; Pathologic Processes; Postoperative Complications; Neurocognitive Disorders; Cognition Disorders; Cognitive Dysfunction; Postoperative Cognitive Complications; Necrosis; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Cholinergic Agents; Enzyme Inhibitors; Nootropic Agents; Cholinesterase Inhibitors; Donepezil
• Other Study ID Numbers: RJ20161003

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No