Effects of Amantadine on Postoperative Cognitive Dysfunction

NCT03527134 | Unknown

• 1 other identifier: 2017-34
• Study Type: interventional
• Target: 390
• Locations: 1 country
• Sites: 1

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.

Conditions

Postoperative Cognitive Dysfunction

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Number of patients with postoperative cognitive dysfunction (POCD) (POCD is a composite outcome measure)

  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

  Up to 5 days after the surgery

• Length of hospital stay

  Up to 3 months after the surgery

• Degree of change in growth factor

  Up to 5 days after the surgery

Study Arms (2)

Amantadine treatment

EXPERIMENTAL

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

Drug: Amantadine

No-treatment

NO INTERVENTION

Patients will not receive any treatment.

Interventions

Amantadine DRUG

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.

Amantadine treatment

Eligibility Criteria

• Age: 60 Years - 100 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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)

Sponsors & Collaborators

• Zhiyi Zuo: lead
• Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University: collaborator
• Sun Yat-sen University: collaborator

Study Sites (1)

Sun Yat-Sen Memorial Hospital

Guangzhou, Guangdong, 510120, China

Location

MeSH Terms

Conditions

Postoperative Cognitive Complications

Interventions

Amantadine

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Cognitive Dysfunction; Cognition Disorders; Neurocognitive Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Adamantane; Bridged-Ring Compounds; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals

Central Study Contacts

Yujuan Li, MD

CONTACT

15918734156; yujuan_04@hotmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor

Model Details: Two groups: one with amantadine treatment and the other with amantadine treatment.

Study Record Dates

• First Submitted: April 23, 2018
• First Posted: May 17, 2018
• Study Start: April 30, 2019
• Primary Completion: July 1, 2021
• Study Completion: October 1, 2021
• Last Updated: January 3, 2019

Record last verified: 2019-01

Locations

CN (1)