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 University

Status and phase: Unknown; Phase 4

Conditions: Postoperative Cognitive Dysfunction

Treatments: Drug: Amantadine Sulfate; Drug: Placebo (for amantadine sulphate)

Study type: Interventional

Funder types: Other

Identifiers

NCT03988010

2011-KAEK-80

Details and patient eligibility

About

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

Full 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.

Enrollment: 54 estimated patients

Sex: All

Ages: 60+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

---

54 participants in 2 patient groups, including a placebo group

Amantadine Sulphate

Experimental group

Description:

200 mg ıv Amantadine Sulphate in 500 cc solution

Treatment:

Drug: Amantadine Sulfate

Placebo group

Placebo Comparator group

Description:

iv 500 cc %0.9 sodium chloride

Treatment:

Drug: Placebo (for amantadine sulphate)