Efficiency of Donepezil in Elderly Patients for Prevention of POCD Dysfunction

• Sponsor: RenJi Hospital (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT04423276
• Collaborator: Shanghai Guanghua Hospital of Integrated Traditional Chinese and Western Medicine (Other), Tenth People's Hospital of Tongji Univeristy (Other)
• Enrollment: 360
• Location: 1
• Arms: 2
• Anticipated Duration (Months): 29.6
• Patients Per Site Per Month: 12.2

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Total Knee Arthroplasty; Fracture of Head of Femur Articular Displaced; Protrusion of Intervertebral Disc	Drug: Donepezil; Drug: Placebo	Phase 4

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 360 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Prevention
• Official Title: Efficiency of Donepezil in Elderly Patients Undergoing Orthopedic Surgery Due to Underlying Postoperative Cognitive Dysfunction, a Multicenter Randomized Controlled Trial
• Actual Study Start Date: Jun 14, 2020
• Anticipated Primary Completion Date: Dec 1, 2021
• Anticipated Study Completion Date: Dec 1, 2022

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. The incidence of POCD after the surgery. [up to 7 days]

Secondary Outcome Measures

1. The incidence of postoperative delirium after surgery. [1 to 7 days after surgery]

2. POCD incidence one month, six months and one year after surgery. [one month, six months and one year after surgery]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 60 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Renji Hospital	Shanghai	Shanghai	China	200127

Sponsors and Collaborators

• RenJi Hospital
• Shanghai Guanghua Hospital of Integrated Traditional Chinese and Western Medicine
• Tenth People's Hospital of Tongji Univeristy

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: RenJi Hospital
• ClinicalTrials.gov Identifier: NCT04423276
• Other Study ID Numbers: DNPQ20200523
• First Posted: Jun 9, 2020
• Last Update Posted: Dec 29, 2020
• Last Verified: Dec 1, 2020

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Donepezil

Study Results

No Results Posted as of Dec 29, 2020