Efficiency of Donepezil in Elderly Patients for Prevention of POCD Dysfunction

NCT04423276 | Unknown Phase 4

• 1 other identifier: DNPQ20200523
• Study Type: interventional
• Target: 360
• Locations: 1 country
• Sites: 1

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.

Conditions

Total Knee Arthroplasty; Fracture of Head of Femur Articular Displaced; Protrusion of Intervertebral Disc

Outcome Measures

Primary Outcomes (1)

• The incidence of POCD after the surgery.

  up to 7 days

Secondary Outcomes (2)

• The incidence of postoperative delirium after surgery.

  1 to 7 days after surgery

• POCD incidence one month, six months and one year after surgery.

  one month, six months and one year after surgery

Study Arms (2)

Control

PLACEBO COMPARATOR

Drug: Placebo

Donepezil

EXPERIMENTAL

Drug: Donepezil

Interventions

Donepezil DRUG

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

Donepezil

Placebo DRUG

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

Control

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

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

Sponsors & Collaborators

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

Study Sites (1)

Renji Hospital

Shanghai, Shanghai Municipality, 200127, China

RECRUITING

Related Publications (1)

• Zhu H, Cong L, Chen Y, Chen S, Chen L, Huang Z, Zhou J, Xiao J, Huang Y, Su D. Efficiency of donepezil in elderly patients undergoing orthopaedic surgery due to underlying post-operative cognitive dysfunction: study protocol for a multicentre randomised controlled trial. Trials. 2021 Oct 9;22(1):688. doi: 10.1186/s13063-021-05648-0.

  PMID: 34627332 DERIVED

MeSH Terms

Interventions

Donepezil

Intervention Hierarchy (Ancestors)

Indans; Indenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Polycyclic Compounds

Study Officials

• Diansan Su

  Department of Anesthesiology Renji Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

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

CONTACT

+8618616514088; diansansu@yahoo.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 6, 2020
• First Posted: June 9, 2020
• Study Start: June 14, 2020
• Primary Completion: December 1, 2021
• Study Completion: December 1, 2022
• Last Updated: December 29, 2020

Record last verified: 2020-12

Locations

CN (1)