Effects of Amantadine on Postoperative Cognitive Dysfunction

Not Applicable

• Conditions: Postoperative Cognitive Dysfunction
• Interventions: Drug: Amantadine

• Registration Number: NCT03527134
• Lead Sponsor: Zhiyi Zuo

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.

Study Timeline

• Study First Submitted: 2018-04-23
• Study First Submitted QC: 2018-05-03
• Study First Posted: 2018-05-17
• Status Verified: 2019-01
• Last Update Submitted: 2019-01-02
• Last Update Posted: 2019-01-03
• Study Start: 2019-04-30
• Primary Completion: 2021-07
• Study Completion: 2021-10

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 390

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Amantadine treatment	Amantadine	To determine whether amantadine is effective in reducing the occurrence of postoperative cognitive dysfunction.

Primary Outcome Measures

Name	Time	Method
Number of patients with postoperative cognitive dysfunction (POCD) (POCD is a composite outcome measure)	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

Secondary Outcome Measures

Name	Time	Method
Time for bowel function return after surgery	up to 2 weeks after the surgery
Degree of change in growth factor	Up to 5 days after the surgery	Brain-derived neurotrophic factor and glial cell derived neurotrophic factor
Length of hospital stay	Up to 3 months after the surgery
Number of patients with postoperative cognitive dysfunction (POCD) (POCD is a composite outcome measure)	At 3 months 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
Degree of increase of stress hormone	Up to 5 days after the surgery	Adrenocorticotropic Hormone

Trial Locations

Locations (1)

Sun Yat-Sen Memorial Hospital; 🇨🇳 Guangzhou, Guangdong, China