Clinical trial NCT02256319: Dexmedetomidine vs Propofol on the Recordings of Deep Brain Activity Measured Through Implanted Stimulators
Official title: Effects of Dexmedetomidine vs Propofol on the Recordings of Deep Brain Activity (Local Field Potentials) Measured Through Implanted Stimulators
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Parkinson's Disease
Keywords: Deep brain stimulation
Dexmedetomidine
Propofol
Lead sponsor: Clinica Universidad de Navarra, Universidad de Navarra
Sponsor class: OTHER
First posted: 2014-10-03
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: SUPPORTIVE_CARE

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 or propofol. The recording is made through a deep brain stimulation (DBS) electrode implanted for PD management.

The investigators hypothesize that dexmedetomidine produces fewer changes as compared to propofol, and that those changes are consistent and recognizable when compared to activity in patients not exposed to any sedation. Typification of those changes would in the future allow for patients to undergo this surgery comfortably while not compromising the quality of the recording and of the final clinical outcome. The principal variable analyzed is the signal's power in each of the frequency bands, absolute and relative. The analysis will include usual clinical methods such as rapid Fourier transform (FFT) and window fast Fourier transform (WFFT), wavelet analysis, Gabor, and coherence.

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 IV clinical trial evaluating the effects of a drug outside the approved.

The study takes part in three phases:

1. DBS placement under sedation with dexmedetomidine at 0.2 μg/kg/h. This will be called "dexmedetomidine record".
2. Four days later and with no sedation, a recording will be registered in one of the specialized electrically isolated rooms at the Neurophysiology Department. This will be dubbed "basal recording". The equipment used is also the standard one used for routine postoperative recordings.
3. 5 days after the initial surgery, and following the protocol in place for these procedures, the tunnelization and battery placement will take place. This is done under general anaesthesia. During anaesthetic induction, the patient is exposed to incremental doses of propofol. Different plasmatic concentrations will be targeted using the mathematical model in the target controlled infusion (TCI) pump. These recordings will be called "propofol at a 0.5, 1, 1.5, 2, 2.5 μg/mL".

Eligibility criteria: Inclusion Criteria:

* 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 Criteria:

* 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.

Primary outcomes:
measure: Signal power of the local field potentials.
timeFrame: 5 minutes for each record
Secondary outcomes:
measure: UPDRS-III score
timeFrame: 2 minutes for each score
Other outcomes:
Locations:
city: Pamplona
country: Spain
facility: University of Navarra Clinic
state: Navarra
Study officials:
affiliation: Staff of the deparment of Anestesiology
name: Martínez S Antonio, Doctor
role: PRINCIPAL_INVESTIGATOR
References:
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