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Effects of Amantadine on Postoperative Cognitive Dysfunction

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ClinicalTrials.gov Identifier: NCT03527134
Recruitment Status : Not yet recruiting
First Posted : May 17, 2018
Last Update Posted : January 3, 2019
Sponsor:
Collaborators:
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Sun Yat-sen University
Information provided by (Responsible Party):
Zhiyi Zuo, Sun Yat-sen University

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.

Condition or disease Intervention/treatment Phase
Postoperative Cognitive Dysfunction Drug: Amantadine Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 390 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Two groups: one with amantadine treatment and the other with amantadine treatment.
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effects of Amantadine on Postoperative Cognitive Dysfunction in Elderly Patients With Elective Abdominal Surgery
Estimated Study Start Date : April 30, 2019
Estimated Primary Completion Date : July 2021
Estimated Study Completion Date : October 2021

Resource links provided by the National Library of Medicine


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.



Primary Outcome Measures :
  1. Number of patients with postoperative cognitive dysfunction (POCD) (POCD is a composite outcome measure) [ Time Frame: 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 :
  1. Number of patients with postoperative cognitive dysfunction (POCD) (POCD is a composite outcome measure) [ Time Frame: 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

  2. Time for bowel function return after surgery [ Time Frame: up to 2 weeks after the surgery ]
  3. Degree of increase of stress hormone [ Time Frame: Up to 5 days after the surgery ]
    Adrenocorticotropic Hormone

  4. Length of hospital stay [ Time Frame: Up to 3 months after the surgery ]
  5. Degree of change in growth factor [ Time Frame: Up to 5 days after the surgery ]
    Brain-derived neurotrophic factor and glial cell derived neurotrophic factor



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Ages Eligible for Study:   60 Years to 100 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03527134


Contacts
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Contact: Yujuan Li, MD 15918734156 yujuan_04@hotmail.com

Locations
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China, Guangdong
Sun Yat-Sen Memorial Hospital Recruiting
Guangzhou, Guangdong, China, 510120
Contact: Yujuan Li, MD, Ph.D.    15918734156    Yujuan_04@hotmail.com   
Principal Investigator: Yujuan Li         
Sponsors and Collaborators
Zhiyi Zuo
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Sun Yat-sen University

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Responsible Party: Zhiyi Zuo, Professor, Sun Yat-sen University
ClinicalTrials.gov Identifier: NCT03527134     History of Changes
Other Study ID Numbers: 2017-34
First Posted: May 17, 2018    Key Record Dates
Last Update Posted: January 3, 2019
Last Verified: January 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Amantadine
Cognitive Dysfunction
Cognition Disorders
Neurocognitive Disorders
Mental Disorders
Antiparkinson Agents
Anti-Dyskinesia Agents
Antiviral Agents
Anti-Infective Agents
Dopamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents