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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
390
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.
Sun Yat-Sen Memorial Hospital
Guangzhou, Guangdong, China
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
Time frame: At 7 days after the surgery
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
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
Adrenocorticotropic 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
Brain-derived neurotrophic factor and glial cell derived neurotrophic factor
Time frame: Up to 5 days after the surgery
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