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

NCT03988010 | Unknown Phase 4

• 1 other identifier: 2011-KAEK-80
• Study Type: interventional
• Target: 54
• Locations: 1 country
• Sites: 1

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

Conditions

Postoperative Cognitive Dysfunction

Keywords

amantadine sulphate; postoperative cognitive dysfunction; laparoscopic radical prostatectomy

Outcome Measures

Primary Outcomes (1)

• Mini Menthal Test

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

  24 hours after surgery

Secondary Outcomes (1)

• Verbal analog Pain Scores on rest and movement

  48 hours after surgrey

Study Arms (2)

Amantadine Sulphate

EXPERIMENTAL

200 mg ıv Amantadine Sulphate in 500 cc solution

Drug: Amantadine Sulfate

Placebo group

PLACEBO COMPARATOR

iv 500 cc %0.9 sodium chloride

Drug: Placebo (for amantadine sulphate)

Interventions

Amantadine Sulfate DRUG

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

Amantadine Sulphate

Placebo (for amantadine sulphate) DRUG

500 cc 0.9% sodium chloride

Placebo group

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \- ASA II-III Patient

You may not qualify if:

• 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

Sponsors & Collaborators

• TC Erciyes University: lead

Study Sites (1)

Erciyes Univercity

Kayseri, Melikgazi, 38030, Turkey (Türkiye)

Location

Related 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 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.

  PMID: 9525362 RESULT

• 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.

  PMID: 12648190 RESULT

• 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.

  PMID: 25251457 RESULT

• 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.

  PMID: 15374380 RESULT

MeSH Terms

Conditions

Postoperative Cognitive Complications

Interventions

Amantadine

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Cognitive Dysfunction; Cognition Disorders; Neurocognitive Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Adamantane; Bridged-Ring Compounds; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals

Study Officials

• Gulen Guler

  TC Erciyes University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Masking Details: Randomise double blind placebo- controlled study
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: 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.

Study Record Dates

• First Submitted: May 30, 2019
• First Posted: June 17, 2019
• Study Start: May 1, 2019
• Primary Completion: December 1, 2019
• Study Completion: December 1, 2019
• Last Updated: June 20, 2019

Record last verified: 2019-06

Locations

TU (1)