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

TC Erciyes University54 enrolled

Overview

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

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

DOUBLE

Enrollment

Conditions

Postoperative Cognitive Dysfunction

Interventions

Amantadine SulfateDRUG

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

Placebo (for amantadine sulphate)DRUG

500 cc 0.9% sodium chloride

Eligibility

Sex: ALLMin age: 60 Years

Medical Language ↔ Plain English

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

Locations (1)

Erciyes Univercity

Kayseri, Melikgazi, Turkey (Türkiye)

Outcomes

Primary Outcomes

Mini Menthal Test

cognitive function scale, Patients will be administered 24 hours after surgery.

Time frame: 24 hours after surgery

Secondary Outcomes

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.

Time frame: 48 hours after surgrey

Data from ClinicalTrials.gov

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