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Effects of Amantadine on Postoperative Cognitive Dysfunction

Primary Purpose

Postoperative Cognitive Dysfunction

Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Amantadine
Sponsored by
Zhiyi Zuo
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Postoperative Cognitive Dysfunction

Eligibility Criteria

60 Years - 100 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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)

Sites / Locations

  • Sun Yat-Sen Memorial Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Amantadine treatment

No-treatment

Arm Description

To determine whether amantadine is effective in reducing the occurrence of postoperative cognitive dysfunction.

Patients will not receive any treatment.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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
Time for bowel function return after surgery
Degree of increase of stress hormone
Adrenocorticotropic Hormone
Length of hospital stay
Degree of change in growth factor
Brain-derived neurotrophic factor and glial cell derived neurotrophic factor

Full Information

First Posted
April 23, 2018
Last Updated
January 2, 2019
Sponsor
Zhiyi Zuo
Collaborators
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University, Sun Yat-sen University
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1. Study Identification

Unique Protocol Identification Number
NCT03527134
Brief Title
Effects of Amantadine on Postoperative Cognitive Dysfunction
Official Title
Effects of Amantadine on Postoperative Cognitive Dysfunction in Elderly Patients With Elective Abdominal Surgery
Study Type
Interventional

2. Study Status

Record Verification Date
January 2019
Overall Recruitment Status
Unknown status
Study Start Date
April 30, 2019 (Anticipated)
Primary Completion Date
July 2021 (Anticipated)
Study Completion Date
October 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Zhiyi Zuo
Collaborators
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University, Sun Yat-sen University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postoperative Cognitive Dysfunction

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Two groups: one with amantadine treatment and the other with amantadine treatment.
Masking
ParticipantCare ProviderOutcomes Assessor
Allocation
Randomized
Enrollment
390 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Amantadine treatment
Arm Type
Experimental
Arm Description
To determine whether amantadine is effective in reducing the occurrence of postoperative cognitive dysfunction.
Arm Title
No-treatment
Arm Type
No Intervention
Arm Description
Patients will not receive any treatment.
Intervention Type
Drug
Intervention Name(s)
Amantadine
Intervention Description
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.
Primary Outcome Measure Information:
Title
Number of patients with postoperative cognitive dysfunction (POCD) (POCD is a composite outcome measure)
Description
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 Frame
At 7 days after the surgery
Secondary Outcome Measure Information:
Title
Number of patients with postoperative cognitive dysfunction (POCD) (POCD is a composite outcome measure)
Description
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 Frame
At 3 months after the surgery
Title
Time for bowel function return after surgery
Time Frame
up to 2 weeks after the surgery
Title
Degree of increase of stress hormone
Description
Adrenocorticotropic Hormone
Time Frame
Up to 5 days after the surgery
Title
Length of hospital stay
Time Frame
Up to 3 months after the surgery
Title
Degree of change in growth factor
Description
Brain-derived neurotrophic factor and glial cell derived neurotrophic factor
Time Frame
Up to 5 days after the surgery

10. Eligibility

Sex
All
Minimum Age & Unit of Time
60 Years
Maximum Age & Unit of Time
100 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: major elective gynecological, prostate or bladder surgery patients who are ≥ 60 years old. 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. lack of serious hearing and vision impairment and be able to read so that neurobehavioral tests can be performed. Exclusion Criteria: Patients are not expected to be alive for longer than 3 months. Mini-mental State Examination (MMSE) [18] score ≤ 23. history of dementia, psychiatric illness or any diseases of central nervous system. current use of sedatives or antidepressant. alcoholism and drug dependence. patients previously included in this study (for patients who have second intra-abdominal surgery during the study period). difficult to follow up or patients with poor compliance. uncontrolled hypertension (> 180/100 mmHg)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Yujuan Li, MD
Phone
15918734156
Email
yujuan_04@hotmail.com
Facility Information:
Facility Name
Sun Yat-Sen Memorial Hospital
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510120
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yujuan Li, MD, Ph.D.
Phone
15918734156
Email
Yujuan_04@hotmail.com
First Name & Middle Initial & Last Name & Degree
Yujuan Li

12. IPD Sharing Statement

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Effects of Amantadine on Postoperative Cognitive Dysfunction

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