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

Phase 4

• Conditions: Postoperative Cognitive Dysfunction
• Interventions: Drug: Amantadine Sulfate; Drug: Placebo (for amantadine sulphate)

• Registration Number: NCT03988010
• Lead Sponsor: TC Erciyes University

Brief Summary

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

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 Timeline

• Study Start: 2019-05-01
• Study First Submitted: 2019-05-30
• Status Verified: 2019-06
• Study First Submitted QC: 2019-06-14
• Study First Posted: 2019-06-17
• Last Update Submitted: 2019-06-18
• Last Update Posted: 2019-06-20
• Primary Completion: 2019-12-01
• Study Completion: 2019-12-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 54

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Amantadine Sulphate	Amantadine Sulfate	200 mg ıv Amantadine Sulphate in 500 cc solution
Placebo group	Placebo (for amantadine sulphate)	iv 500 cc %0.9 sodium chloride

Primary Outcome Measures

Name	Time	Method
Mini Menthal Test	24 hours after surgery	cognitive function scale, Patients will be administered 24 hours after surgery.

Secondary Outcome Measures

Name	Time	Method
Verbal analog Pain Scores on rest and movement	48 hours after surgrey	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.

Trial Locations

Locations (1)

Erciyes Univercity; 🇹🇷 Kayseri, Melikgazi, Turkey