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Trial record 5 of 138 for:    AMANTADINE

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

Tracking Information
First Submitted Date  ICMJE April 23, 2018
First Posted Date  ICMJE May 17, 2018
Last Update Posted Date January 3, 2019
Estimated Study Start Date  ICMJE April 30, 2019
Estimated Primary Completion Date July 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 3, 2018)
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
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03527134 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: May 3, 2018)
  • 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
  • Time for bowel function return after surgery [ Time Frame: up to 2 weeks after the surgery ]
  • Degree of increase of stress hormone [ Time Frame: Up to 5 days after the surgery ]
    Adrenocorticotropic Hormone
  • Length of hospital stay [ Time Frame: Up to 3 months after the surgery ]
  • 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
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Effects of Amantadine on Postoperative Cognitive Dysfunction
Official Title  ICMJE Effects of Amantadine on Postoperative Cognitive Dysfunction in Elderly Patients With Elective Abdominal Surgery
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 Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE 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
Condition  ICMJE Postoperative Cognitive Dysfunction
Intervention  ICMJE 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.
Study Arms  ICMJE
  • Experimental: Amantadine treatment
    To determine whether amantadine is effective in reducing the occurrence of postoperative cognitive dysfunction.
    Intervention: Drug: Amantadine
  • No Intervention: No-treatment
    Patients will not receive any treatment.
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Not yet recruiting
Estimated Enrollment  ICMJE
 (submitted: May 3, 2018)
390
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE October 2021
Estimated Primary Completion Date July 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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)
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 60 Years to 100 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE
Contact: Yujuan Li, MD 15918734156 yujuan_04@hotmail.com
Listed Location Countries  ICMJE China
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03527134
Other Study ID Numbers  ICMJE 2017-34
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Zhiyi Zuo, Sun Yat-sen University
Study Sponsor  ICMJE Zhiyi Zuo
Collaborators  ICMJE
  • Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
  • Sun Yat-sen University
Investigators  ICMJE Not Provided
PRS Account Sun Yat-sen University
Verification Date January 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP