Perioperative Treatment of Parkinsonian Patients With Parenteral Amantadine

Phase 2

Terminated

• Conditions: Parkinson Disease; Perioperative Care
• Interventions: Drug: Amantadine

• Registration Number: NCT00600093
• Lead Sponsor: Rabin Medical Center

Brief Summary

The purpose of this study is to determine whether administrating of Amantadine (a dopamine agonist) to patients suffering from Parkinson disease during the perioperative period is safe, and to asses potential benefits of this treatment.

Detailed Description

Not available

Study Timeline

• Study Start: 2008-01
• Study First Submitted: 2008-01-13
• Study First Submitted QC: 2008-01-13
• Study First Posted: 2008-01-24
• Status Verified: 2011-07
• Primary Completion: 2011-07
• Study Completion: 2011-07
• Last Update Submitted: 2011-07-24
• Last Update Posted: 2011-07-26

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

• Patient with a diagnosis of Parkinson Disease refered for surgery at our institution.

Exclusion Criteria

• Cardiac and neurosurgical procedures
• Inability to sign informed Consent
• allergy to Amantadine
• Congestive heart failure
• Arrythmia (including bradycardia below 55 bpm)
• renal failure (creatinin above 1.5)
• If a patient will develop agitation or delirium lasting longer then 8 hours he will not receive the second dose of amantadine.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
A	Amantadine	-

Primary Outcome Measures

Name	Time	Method
Mortality, Surgical site infection, Pneumonia, Myocardial Infarction, Cerebral Vascular Accident (CVA).	28 days

Secondary Outcome Measures

Name	Time	Method
UPDRS score	2,28 days
Pain (vas score), Analgetic drugs requirement	2 days

Trial Locations

Locations (1)

Rabin Medical Center; 🇮🇱 Petah Tikva, Israel