Postoperative Cognitive DysfunctionNCT03527134
Effects of Amantadine on Postoperative Cognitive Dysfunction
A study testing Amantadine in people with Postoperative Cognitive Dysfunction, run by Zhiyi Zuo at 1 site in China.
Trial summary
Post-operative cognitive dysfunction (POCD) is a fairly well-documented clinical phenomenon. Investigators will determine whether amantadine can reduce the occurrence of POCD in elderly patients with major abdominal surgery. Read more about this study
- Who is it for?
- Ages 60 to 100 yearsHealthy volunteers can take part
- Conditions the study is for
- Postoperative Cognitive Dysfunction
- What is being tested?
- Amantadine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 390 participants
- Where
- 1 siteChina
- Study dates
- 30 Apr 2019to Oct 2021
- Phase
- Interventional
- 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 to 100 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- major elective gynecological, prostate or bladder surgery patients who are ≥ 60 years old.
- the surgery is laparoscopic surgery and is expected to last for ≥ 2 hours under general anesthesia and the patient will stay in hospital for at least 7 days after surgery.
- lack of serious hearing and vision impairment and be able to read so that neurobehavioral tests can be performed.
Who cannot join
- Patients are not expected to be alive for longer than 3 months.
- Mini-mental State Examination (MMSE) [18] score ≤ 23.
- history of dementia, psychiatric illness or any diseases of central nervous system.
- current use of sedatives or antidepressant.
- alcoholism and drug dependence.
- patients previously included in this study (for patients who have second intra-abdominal surgery during the study period).
- difficult to follow up or patients with poor compliance.
- uncontrolled hypertension (> 180/100 mmHg)
Trial locations and contacts
1 site in 1 country.
China1 site
Sun Yat-Sen Memorial Hospital
Guangzhou, Guangdong, 510120
Yujuan Li, MD, Ph.D., 15918734156, Yujuan_04@hotmail.com
Yujuan Li
About this study
Official title: Effects of Amantadine on Postoperative Cognitive Dysfunction in Elderly Patients With Elective Abdominal Surgery
Post-operative cognitive dysfunction (POCD) is a fairly well-documented clinical phenomenon. Investigators will determine whether amantadine can reduce the occurrence of POCD in elderly patients with major abdominal surgery.
Read the detailed description
Patients who are 60 years old or older for laparoscopic abdominal surgery will be randomly assigned into two groups: 1) no-treatment group, and 2) amantadine-treated group. Each group will have 150 patients. In addition, investigators will need 90 subjects in the control group. The data of these control subjects will be used to normalize the data of the two studied groups to diagnose POCD. The subjects in control groups will also be elderly but without the exposure to anesthesia and surgery.
- Conditions
- Postoperative Cognitive Dysfunction
- Being tested
- Amantadine
- Medical subject headings
- Postoperative Cognitive Complications
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AmantadineDrug
patients will receive amantadine 100 mg by month 2 h before the induction of general anesthesia and then 100 mg each time, three times per day for 5 days.
| Study group | Role | What they receive |
|---|---|---|
| Amantadine treatment | Experimental | To determine whether amantadine is effective in reducing the occurrence of postoperative cognitive dysfunction. Receives: Drug: Amantadine |
| No-treatment | No intervention | Patients will not receive any treatment. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of patients with postoperative cognitive dysfunction (POCD) (POCD is a composite outcome measure)
The existence of POCD will be determined by Visual Verbal Learning Test based on the Rey's Auditory Recall of words, Concept Shifting Test, Stroop Color Word Interference Test and Letter-Digit Coding based on the Symbol Digit Substitution Test
Measured: At 7 days after the surgery
Secondary outcomes (5)
Number of patients with postoperative cognitive dysfunction (POCD) (POCD is a composite outcome measure)
The existence of POCD will be determined by Visual Verbal Learning Test based on the Rey's Auditory Recall of words, Concept Shifting Test, Stroop Color Word Interference Test and Letter-Digit Coding based on the Symbol Digit Substitution Test
Measured: At 3 months after the surgery
Time for bowel function return after surgery
Measured: up to 2 weeks after the surgery
Degree of increase of stress hormone
Adrenocorticotropic Hormone
Measured: Up to 5 days after the surgery
Length of hospital stay
Measured: Up to 3 months after the surgery
Degree of change in growth factor
Brain-derived neurotrophic factor and glial cell derived neurotrophic factor
Measured: Up to 5 days after the surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 May 2018
- Study start30 Apr 2019 (estimated)
- Primary completionJul 2021 (estimated)
- Study completionOct 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postoperative Cognitive DysfunctionStudies of the same condition, open and under way.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Two groups: one with amantadine treatment and the other with amantadine treatment.
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 390 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Zhiyi Zuo
- Sponsor type
- University, hospital or other
- Collaborators
- Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University, Sun Yat-sen University
- Responsible party
- Sponsor-investigator, Zhiyi Zuo, Sun Yat-sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03527134
- Sponsor's protocol ID
- 2017-34
- Status last verified
- Jan 2019
- First submitted
- 23 Apr 2018
- Last updated
- 3 Jan 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Amantadine on Postoperative Cognitive Dysfunction in Elderly Patients With Elective Abdominal Surgery
- ClinicalTrials.gov ID
- NCT03527134
- Acronym / sponsor ID
- 2017-34
- Conditions
- Postoperative Cognitive Dysfunction
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 390 participants (estimated)
- Lead sponsor
- Zhiyi ZuoUniversity, hospital or other
- Collaborators
- Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University, Sun Yat-sen University
- Study start
- 30 Apr 2019 (estimated)
- Primary completion
- Jul 2021 (estimated)
- Study completion
- Oct 2021 (estimated)
- First posted
- 17 May 2018 (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.
Post-operative cognitive dysfunction (POCD) is a fairly well-documented clinical phenomenon. Investigators will determine whether amantadine can reduce the occurrence of POCD in elderly patients with major abdominal surgery.
Detailed description
Patients who are 60 years old or older for laparoscopic abdominal surgery will be randomly assigned into two groups: 1) no-treatment group, and 2) amantadine-treated group. Each group will have 150 patients. In addition, investigators will need 90 subjects in the control group. The data of these control subjects will be used to normalize the data of the two studied groups to diagnose POCD. The subjects in control groups will also be elderly but without the exposure to anesthesia and surgery.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
- Model description
- Two groups: one with amantadine treatment and the other with amantadine treatment.
| Arm | Type | Receives |
|---|---|---|
| Amantadine treatment | Experimental | Drug: AmantadineTo determine whether amantadine is effective in reducing the occurrence of postoperative cognitive dysfunction. |
| No-treatment | No intervention | –Patients will not receive any treatment. |
Who may qualify
- Ages
- 60 to 100 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- major elective gynecological, prostate or bladder surgery patients who are ≥ 60 years old.
- the surgery is laparoscopic surgery and is expected to last for ≥ 2 hours under general anesthesia and the patient will stay in hospital for at least 7 days after surgery.
- lack of serious hearing and vision impairment and be able to read so that neurobehavioral tests can be performed.
Key exclusion criteria (8 listed)
- Patients are not expected to be alive for longer than 3 months.
- Mini-mental State Examination (MMSE) [18] score ≤ 23.
- history of dementia, psychiatric illness or any diseases of central nervous system.
- current use of sedatives or antidepressant.
- alcoholism and drug dependence.
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 |
|---|---|---|
| Amantadinepatients will receive amantadine 100 mg by month 2 h before the induction of general anesthesia and then 100 mg each time, three times per day for 5 days. | Drug | Amantadine treatment |
Primary outcome
Number of patients with postoperative cognitive dysfunction (POCD) (POCD is a composite outcome measure)
Time frame: At 7 days after the surgery
The existence of POCD will be determined by Visual Verbal Learning Test based on the Rey's Auditory Recall of words, Concept Shifting Test, Stroop Color Word Interference Test and Letter-Digit Coding based on the Symbol Digit Substitution Test
5 secondary outcomes
Number of patients with postoperative cognitive dysfunction (POCD) (POCD is a composite outcome measure)
Time frame: At 3 months after the surgery
Time for bowel function return after surgery
Time frame: up to 2 weeks after the surgery
Degree of increase of stress hormone
Time frame: Up to 5 days after the surgery
Length of hospital stay
Time frame: Up to 3 months after the surgery
Degree of change in growth factor
Time frame: Up to 5 days after the surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jan 2019.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Amantadine in people with Postoperative Cognitive Dysfunction, run by Zhiyi Zuo 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 3 inclusion and 8 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 3 Jan 2019. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
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 Yujuan Li, MD (15918734156, yujuan_04@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of patients with postoperative cognitive dysfunction (POCD) (POCD is a composite outcome measure) (time frame: At 7 days after the surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 3 Jan 2019.