Evaluation of the Effect of Preoperative Intravenous Amantadine Sulfate on the Postoperative Early Cognitive Functions in a Elderly Patient With Laparoscopic Radical Prostatectomy

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

54 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-05-01

Study Completion Date

2019-12-01

Brief Summary

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Evaluation of the effect of preoperative intravenous administration of amantadine sulfate on the prevention of the development of early cognitive dysfunction in elderly patients undergoing laparoscopic radical prostatectomy

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Detailed Description

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Investigators believe that the preoperative prophylactic amantadine sulphate will reduce the incidence of postoperative cognitive disfunction (POCD) in patients with laparoscopic radical prostatectomy due to the neuroprotective effect, alertness enhancing effect and neuron protective effects.

Conditions

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Postoperative Cognitive Dysfunction

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Patients randomly allocated to two treatment groups: Amantadine Sulphate group (Group I) and the placebo group (Group II). Participants will receive two doses of amantadine sulphate in the form of three-hour infusions. The first infusion will be administered 8 hours before the operation and the second infusion will be terminated just before the operation.

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Participants Caregivers

Randomise double blind placebo- controlled study

Study Groups

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Amantadine Sulphate

200 mg ıv Amantadine Sulphate in 500 cc solution

Group Type EXPERIMENTAL

Amantadine Sulfate

Intervention Type DRUG

200mg/500ml i.v. solution for infusion

Placebo group

iv 500 cc %0.9 sodium chloride

Group Type PLACEBO_COMPARATOR

Placebo (for amantadine sulphate)

Intervention Type DRUG

500 cc 0.9% sodium chloride

Interventions

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Amantadine Sulfate

200mg/500ml i.v. solution for infusion

Intervention Type DRUG

Placebo (for amantadine sulphate)

500 cc 0.9% sodium chloride

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

\- ASA II-III Patient

Exclusion Criteria

* history of disease related to central nervous system, history of psychiatric disease, history of previous open heart surgery, history of previous craniotomy, renal insufficiency, hepatic failure, history of arrhythmia pre-applied standardized Mini Mental Test (sMMT) less than 24 points

Minimum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No