Total Knee ArthroplastyPhase 4NCT04423276
Efficiency of Donepezil in Elderly Patients for Prevention of POCD Dysfunction
A Phase 4 study testing Donepezil in people with Total Knee Arthroplasty and Fracture of Head of Femur Articular Displaced, run by RenJi Hospital at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Total Knee Arthroplasty, Fracture of Head of Femur Articular Displaced, Protrusion of Intervertebral Disc
- What is being tested?
- Donepezil
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 360 participants
- Where
- 1 siteChina
- Study dates
- 14 Jun 2020to 1 Dec 2022
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 12Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Renji Hospital
Shanghai, Shanghai Municipality, 200127
Diansan Su, +862168383702, diansansu@yahoo.com
About this study
Official title: 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.
- Conditions
- Total Knee Arthroplasty, Fracture of Head of Femur Articular Displaced, Protrusion of Intervertebral Disc
- Being tested
- Donepezil, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DonepezilDrug
Donepezil a cholinesterase inhibitor, 5mg(1 pill)/ day for 7 days Po, was administrated from the day before surgery.
PlaceboDrug
Placebo, 1 pill/ day for 7 days Po, was administrated from the day before surgery.
| Study group | Role | What they receive |
|---|---|---|
| Control | Placebo comparator | Not described Receives: Drug: Placebo |
| Donepezil | Experimental | Not described Receives: Drug: Donepezil |
What is being measured
The primary outcome is the main question the study is designed to answer.
The incidence of POCD after the surgery.
Measured: up to 7 days
Secondary outcomes (2)
The incidence of postoperative delirium after surgery.
Measured: 1 to 7 days after surgery
POCD incidence one month, six months and one year after surgery.
Measured: one month, six months and one year after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jun 2020
- Study start14 Jun 2020
- Primary completion1 Dec 2021 (estimated)
- Study completion1 Dec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Total Knee ArthroplastyStudies of the same condition, open and under way.
- More trials run by RenJi HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 360 participants (estimated)
Sponsor and investigators
- Lead sponsor
- RenJi Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Shanghai Guanghua Hospital of Integrated Traditional Chinese and Western Medicine, Tenth People's Hospital of Tongji Univeristy
- Responsible party
- Sponsor
- Investigators
- Diansan Su, Principal investigator, Department of Anesthesiology Renji Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04423276
- Sponsor's protocol ID
- DNPQ20200523
- Status last verified
- Dec 2020
- First submitted
- 6 Jun 2020
- Last updated
- 29 Dec 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 34627332
Study at a glance
From the registry record, last updated by the sponsor on 29 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficiency of Donepezil in Elderly Patients Undergoing Orthopedic Surgery Due to Underlying Postoperative Cognitive Dysfunction, a Multicenter Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT04423276
- Acronym / sponsor ID
- DNPQ20200523
- Conditions
- Total Knee Arthroplasty, Fracture of Head of Femur Articular Displaced, Protrusion of Intervertebral Disc
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 360 participants (estimated)
- Lead sponsor
- RenJi HospitalUniversity, hospital or other
- Collaborators
- Shanghai Guanghua Hospital of Integrated Traditional Chinese and Western Medicine, Tenth People's Hospital of Tongji Univeristy
- Study start
- 14 Jun 2020 (actual)
- Primary completion
- 1 Dec 2021 (estimated)
- Study completion
- 1 Dec 2022 (estimated)
- First posted
- 9 Jun 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control | Placebo comparator | Drug: Placebo |
| Donepezil | Experimental | Drug: Donepezil |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (12 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DonepezilDonepezil a cholinesterase inhibitor, 5mg(1 pill)/ day for 7 days Po, was administrated from the day before surgery. | Drug | Donepezil |
| PlaceboPlacebo, 1 pill/ day for 7 days Po, was administrated from the day before surgery. | Drug | Control |
Primary outcome
The incidence of POCD after the surgery.
Time frame: up to 7 days
2 secondary outcomes
The incidence of postoperative delirium after surgery.
Time frame: 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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Dec 2020.
- Derived from this study: PubMed 34627332Zhu 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Diansan Su principal investigator
Department of Anesthesiology Renji Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Donepezil in people with Total Knee Arthroplasty and Fracture of Head of Femur Articular Displaced, run by RenJi Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 29 Dec 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Diansan Su, M.D., Ph.D. (+8618616514088, diansansu@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The incidence of POCD after the surgery. (time frame: up to 7 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04423276, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Dec 2020.