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| Name | Class |
|---|---|
| Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University | OTHER |
| Sun Yat-sen University | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Amantadine treatment | Experimental | To determine whether amantadine is effective in reducing the occurrence of postoperative cognitive dysfunction. |
|
| No-treatment | No Intervention | Patients will not receive any treatment. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Amantadine | Drug | 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. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 | At 7 days after the surgery |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | At 3 months after the surgery |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Yujuan Li, MD | Contact | 15918734156 | yujuan_04@hotmail.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sun Yat-Sen Memorial Hospital | Guangzhou | Guangdong | 510120 | China |
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| ID | Term |
|---|---|
| D000079690 | Postoperative Cognitive Complications |
| ID | Term |
|---|---|
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D060825 | Cognitive Dysfunction |
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| ID | Term |
|---|---|
| D000547 | Amantadine |
| ID | Term |
|---|---|
| D000218 | Adamantane |
| D001952 | Bridged-Ring Compounds |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
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Two groups: one with amantadine treatment and the other with amantadine treatment.
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| Time for bowel function return after surgery | up to 2 weeks after the surgery |
| Degree of increase of stress hormone | Adrenocorticotropic Hormone | Up to 5 days after the surgery |
| Length of hospital stay | Up to 3 months after the surgery |
| Degree of change in growth factor | Brain-derived neurotrophic factor and glial cell derived neurotrophic factor | Up to 5 days after the surgery |
| D003072 | Cognition Disorders |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |
| D009930 |
| Organic Chemicals |