Status:
COMPLETED
Dexmedetomidine vs Propofol on the Recordings of Deep Brain Activity Measured Through Implanted Stimulators
Lead Sponsor:
Clinica Universidad de Navarra, Universidad de Navarra
Conditions:
Parkinson's Disease
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
This clinical trial has been designed to study and compare changes in deep brain activity (field potentials) in Parkinson's disease (PD) patients while awake, and during sedation with dexmedetomidine ...
Detailed Description
Comparative clinical trial, non blinded, controlled and sequential, evaluating the effects of propofol and dexmedetomidine in the basal ganglia of PD patients through a DBS electrode. It is a phase I...
Eligibility Criteria
Inclusion
- Capacity to understand, consent and commit for the three phases of the study.
- Older than 18 years old.
- The patient is scheduled for DBS electrode placement for PD treatment by his neurologist.
Exclusion
- Allergy or hypersensibility to dexmedetomidine or propofol
- Cardiac blockade (types 2 and 3) without an implanted pacemaker
- Low blood pressure (mean \< 60 mmHg) or symptoms of low cardiac output.
- Severe cerebrovascular disease.
- Pregnancy or nursing mothers.
Key Trial Info
Start Date :
September 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2015
Estimated Enrollment :
12 Patients enrolled
Trial Details
Trial ID
NCT02256319
Start Date
September 1 2014
End Date
December 1 2015
Last Update
December 18 2015
Active Locations (1)
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1
University of Navarra Clinic
Pamplona, Navarre, Spain, 31008