Clinical trial NCT03527134: Effects of Amantadine on Postoperative Cognitive Dysfunction
Official title: Effects of Amantadine on Postoperative Cognitive Dysfunction in Elderly Patients With Elective Abdominal Surgery
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Postoperative Cognitive Dysfunction
Lead sponsor: Sun Yat-sen University
Sponsor class: OTHER
Collaborators: name: Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
name: Sun Yat-sen University
First posted: 2018-05-17
Enrollment: 390
Sex: ALL
Minimum age (years): 60
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Two groups: one with amantadine treatment and the other with amantadine treatment.
Primary purpose: TREATMENT

Brief 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.

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.

Eligibility criteria: Inclusion Criteria:

1. major elective gynecological, prostate or bladder surgery patients who are ≥ 60 years old.
2. 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.
3. lack of serious hearing and vision impairment and be able to read so that neurobehavioral tests can be performed.

Exclusion Criteria:

1. Patients are not expected to be alive for longer than 3 months.
2. Mini-mental State Examination (MMSE) \[18\] score ≤ 23.
3. history of dementia, psychiatric illness or any diseases of central nervous system.
4. current use of sedatives or antidepressant.
5. alcoholism and drug dependence.
6. patients previously included in this study (for patients who have second intra-abdominal surgery during the study period).
7. difficult to follow up or patients with poor compliance.
8. uncontrolled hypertension (\> 180/100 mmHg)

Primary outcomes:
measure: Number of patients with postoperative cognitive dysfunction (POCD) (POCD is a composite outcome measure)
timeFrame: At 7 days after the surgery
Secondary outcomes:
measure: Number of patients with postoperative cognitive dysfunction (POCD) (POCD is a composite outcome measure)
timeFrame: At 3 months after the surgery
measure: Time for bowel function return after surgery
timeFrame: up to 2 weeks after the surgery
measure: Degree of increase of stress hormone
timeFrame: Up to 5 days after the surgery
measure: Length of hospital stay
timeFrame: Up to 3 months after the surgery
measure: Degree of change in growth factor
timeFrame: Up to 5 days after the surgery
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Sun Yat-Sen Memorial Hospital
state: Guangdong
Study officials:
References: