Effects of Amantadine on Postoperative Cognitive Dysfunction

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

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.

Study Overview

• Status: Unknown
• Conditions: Postoperative Cognitive Dysfunction
• Intervention / Treatment: Drug: Amantadine

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 Type: Interventional
• Enrollment (Anticipated): 390
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Yujuan Li, MD; Phone Number: 15918734156; Email: yujuan_04@hotmail.com

Study Locations

• China
  • Guangdong
    • Guangzhou, Guangdong, China, 510120
      • Sun Yat-sen Memorial Hospital
      • Contact: Yujuan Li, MD, Ph.D.; Phone Number: 15918734156; Email: Yujuan_04@hotmail.com
      • Principal Investigator: Yujuan Li

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 60 years to 100 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: TRIPLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Amantadine treatment; To determine whether amantadine is effective in reducing the occurrence of postoperative cognitive dysfunction.	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.
NO_INTERVENTION: No-treatment; Patients will not receive any treatment.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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
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

Collaborators and Investigators

• Sponsor: Zhiyi Zuo
• Collaborators: Sun Yat-sen University; Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

Study record dates

Study Major Dates

• Study Start (ANTICIPATED): April 30, 2019
• Primary Completion (ANTICIPATED): July 1, 2021
• Study Completion (ANTICIPATED): October 1, 2021

Study Registration Dates

• First Submitted: April 23, 2018
• First Submitted That Met QC Criteria: May 3, 2018
• First Posted (ACTUAL): May 17, 2018

Study Record Updates

• Last Update Posted (ACTUAL): January 3, 2019
• Last Update Submitted That Met QC Criteria: January 2, 2019
• Last Verified: January 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Pathologic Processes; Postoperative Complications; Neurocognitive Disorders; Cognition Disorders; Cognitive Dysfunction; Postoperative Cognitive Complications; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents; Peripheral Nervous System Agents; Antiviral Agents; Analgesics; Sensory System Agents; Analgesics, Non-Narcotic; Dopamine Agents; Antiparkinson Agents; Anti-Dyskinesia Agents; Amantadine
• Other Study ID Numbers: 2017-34

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No