Effects of Amantadine on Postoperative Cognitive Dysfunction

Postoperative Cognitive Dysfunction Clinical Trial

Official title:

Effects of Amantadine on Postoperative Cognitive Dysfunction in Elderly Patients With Elective Abdominal Surgery

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03527134
• Other study ID #: 2017-34
• Status: Not yet recruiting
• Phase: N/A
• Start date: April 30, 2019
• Est. completion date: October 2021

Study information

• Verified date: January 2019
• Source: Sun Yat-sen University
• Contact: Yujuan Li, MD
• Phone: 15918734156
• Email: yujuan_04[@]hotmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 390
• Est. completion date: October 2021
• Est. primary completion date: July 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 60 Years to 100 Years

Eligibility

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)

Related Conditions & MeSH terms

• Cognitive Dysfunction
• Postoperative Cognitive Dysfunction

Intervention

Drug:
• Amantadine
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.

Locations

Country	Name	City	State
China	Sun Yat-Sen Memorial Hospital	Guangzhou	Guangdong

Sponsors (3)

Lead Sponsor	Collaborator
Zhiyi Zuo	Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University, Sun Yat-sen University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Secondary	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
Secondary	Time for bowel function return after surgery		up to 2 weeks after the surgery
Secondary	Degree of increase of stress hormone	Adrenocorticotropic Hormone	Up to 5 days after the surgery
Secondary	Length of hospital stay		Up to 3 months after the surgery
Secondary	Degree of change in growth factor	Brain-derived neurotrophic factor and glial cell derived neurotrophic factor	Up to 5 days after the surgery