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

Study Overview
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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

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.

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

Conditions
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Postoperative Cognitive Dysfunction

Intervention / Treatment
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* Drug: Amantadine Sulfate
* Drug: Placebo (for amantadine sulphate)


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: 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.
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Amantadine Sulphate<br>200 mg ıv Amantadine Sulphate in 500 cc solution | Drug: Amantadine Sulfate<br>* 200mg/500ml i.v. solution for infusion<br>|
| Placebo Comparator: Placebo group<br>iv 500 cc %0.9 sodium chloride | Drug: Placebo (for amantadine sulphate)<br>* 500 cc 0.9% sodium chloride<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mini Menthal Test | cognitive function scale, Patients will be administered 24 hours after surgery. | 24 hours after surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Verbal analog Pain Scores on rest and movement | A Research assistant, blinded to the group allocation, interviewed patients and collected data at 5 times intervals ( 2, 4, 6, 12, 24, 48 hours) in the 48 hours postoperatively. Patients were asked to rate their pain using verbal analog scale, where 0= no pain and 10= worst pain possible. | 48 hours after surgrey | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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amantadine sulphate, postoperative cognitive dysfunction, laparoscopic radical prostatectomy