Clinical trial NCT03988010: Evaluation of the Effect of Preoperative Intravenous Amantadine Sulfate on the Postoperative Early Cognitive Functions in a Elderly Patient With Laparoscopic Radical Prostatectomy
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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Postoperative Cognitive Dysfunction
Keywords: amantadine sulphate
postoperative cognitive dysfunction
laparoscopic radical prostatectomy
Lead sponsor: TC Erciyes University
Sponsor class: OTHER
First posted: 2019-06-17
Enrollment: 54
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: PREVENTION

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.

Eligibility criteria: 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

Primary outcomes:
measure: Mini Menthal Test
timeFrame: 24 hours after surgery
Secondary outcomes:
measure: Verbal analog Pain Scores on rest and movement
timeFrame: 48 hours after surgrey
Other outcomes:
Locations:
city: Kayseri
country: Turkey
facility: Erciyes Univercity
state: Melikgazi
Study officials:
affiliation: TC Erciyes University
name: Gulen Guler
role: STUDY_DIRECTOR
References:
citation: 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 postoperative cognitive dysfunction in the elderly ISPOCD1 study. ISPOCD investigators. International Study of Post-Operative Cognitive Dysfunction. Lancet. 1998 Mar 21;351(9106):857-61. doi: 10.1016/s0140-6736(97)07382-0.
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 Cognitive Dysfunction) Investigators. Does anaesthesia cause postoperative cognitive dysfunction? A randomised study of regional versus general anaesthesia in 438 elderly patients. Acta Anaesthesiol Scand. 2003 Mar;47(3):260-6. doi: 10.1034/j.1399-6576.2003.00057.x.
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.
citation: Saletu B, Anderer P, Semlitsch HV, Grunberger 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. doi: 10.1016/0167-4943(92)90039-7.