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

Postoperative Cognitive Dysfunction Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03988010
• Other study ID #: 2011-KAEK-80
• Status: Active, not recruiting
• Phase: Phase 4
• Start date: May 1, 2019
• Est. completion date: December 1, 2019

Study information

• Verified date: June 2019
• Source: TC Erciyes University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 54
• Est. completion date: December 1, 2019
• Est. primary completion date: December 1, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 60 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cognitive Dysfunction
• Postoperative Cognitive Dysfunction

Intervention

Drug:
• Amantadine Sulfate
200mg/500ml i.v. solution for infusion
• Placebo (for amantadine sulphate)
500 cc 0.9% sodium chloride

Locations

Country	Name	City	State
Turkey	Erciyes Univercity	Kayseri	Melikgazi

Sponsors (1)

Lead Sponsor	Collaborator
TC Erciyes University

Country where clinical trial is conducted

Turkey, 

References & Publications (4)

Moller JT, Cluitmans P, Rasmussen LS, Houx P, Rasmussen H, Canet J, Rabbitt P, Jolles J, Larsen K, Hanning CD, Langeron O, Johnson T, Lauven PM, Kristensen PA, Biedler A, van Beem H, Fraidakis O, Silverstein JH, Beneken JE, Gravenstein JS. Long-term posto — View Citation

Rasmussen LS, Johnson T, Kuipers HM, Kristensen D, Siersma VD, Vila P, Jolles J, Papaioannou A, Abildstrom H, Silverstein JH, Bonal JA, Raeder J, Nielsen IK, Korttila K, Munoz L, Dodds C, Hanning CD, Moller JT; ISPOCD2(International Study of Postoperative — View Citation

Saletu B, Anderer P, Semlitsch HV, Grünberger J, Linzmayer L, Chaudhry HR. Amantadine infusions in mild dementia: acute double-blind placebo-controlled EEG mapping and psychometric studies. Arch Gerontol Geriatr. 1992 Jul-Aug;15(1):43-58. — View Citation

Zhang J, Tan H, Jiang W, Zuo Z. Amantadine alleviates postoperative cognitive dysfunction possibly by increasing glial cell line-derived neurotrophic factor in rats. Anesthesiology. 2014 Oct;121(4):773-85. doi: 10.1097/ALN.0000000000000352. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mini Menthal Test	cognitive function scale, Patients will be administered 24 hours after surgery.	24 hours after surgery
Secondary	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