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Dexmedetomidine vs Propofol on the Recordings of Deep Brain Activity Measured Through Implanted Stimulators (DEXPROPAR)

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ClinicalTrials.gov Identifier: NCT02256319
Recruitment Status : Completed
First Posted : October 3, 2014
Last Update Posted : December 18, 2015
Sponsor:
Information provided by (Responsible Party):
Clinica Universidad de Navarra, Universidad de Navarra

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.


Condition or disease Intervention/treatment Phase
Parkinson's Disease Drug: Dexmedetomidine Drug: Propofol Phase 4

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".

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 12 participants
Allocation: Non-Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Effects of Dexmedetomidine vs Propofol on the Recordings of Deep Brain Activity (Local Field Potentials) Measured Through Implanted Stimulators
Study Start Date : September 2014
Actual Primary Completion Date : December 2015
Actual Study Completion Date : December 2015

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Dexmedetomidine recording
Recording registered through the deep brain stimulation electrodes with dexmedetomidine at 0.2 μg/kg/h.
Drug: Dexmedetomidine
Patients will receive a loading dose of 1 µg/kg in 10 min before starting the surgery. The maintenance dose will be 0.2-1 µg/kg/h for a Ramsey Sedation Score of 3-4 during the surgery´s preparation. It will be reduced to 0.2 µg/kg/h 15 min before starting the microelectrode recording for a Ramsey Sedation Score of 2. After the placement of the deep brain stimulator we will record the local field potentials activity. In addition, the subscales of rigidity, tremor and bradykinesia of the Unified Parkinson's Disease Rating Scale (UPDRS-III) score will be evaluated. Once the deep brain stimulator recording and neurologic exploration will be over patients will receive a maintenance dose 0.2-1 µg/kg/h until the end of the surgery. It will be stopped to transfer the patient to the ICU.
Other Name: (S)-4-[1-(2,3-Dimethylphenyl)ethyl]-3H-imidazole

Active Comparator: Propofol recording
Recording registered through the deep brain stimulation electrodes with propofol at plasmatic levels of 0.5, 1, 1.5, 2, 2.5 μg/mL.
Drug: Propofol
The target doses are 0.5, 1, 1.5, 2 and 2.5 µg/kg. For its administration we will use the TCI (target controlled infusion) system. After programming each dose we will wait until the plasma and brain concentration of propofol are stabilized in this target and then we will record the local field potentials activity through the DBS. In addition, the subscales of rigidity, tremor and bradykinesia of the UPDRS-III score will be evaluated.
Other Name: 2,6-diisopropylphenol

No Intervention: Basal recording
Recording registered through the deep brain stimulation electrodes with no sedation .



Primary Outcome Measures :
  1. Signal power of the local field potentials. [ Time Frame: 5 minutes for each record ]
    Signal power separated in bandwidth (theta, slow beta, fast beta, gamma, high frequency); absolute and relative. The comparison will be made between the different measurements: dexmedetomidine, basal and propofol.


Secondary Outcome Measures :
  1. UPDRS-III score [ Time Frame: 2 minutes for each score ]
    Changes in UPDRS-III score with dexmedetomidine and propofol



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02256319


Locations
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Spain
University of Navarra Clinic
Pamplona, Navarra, Spain, 31008
Sponsors and Collaborators
Clinica Universidad de Navarra, Universidad de Navarra
Investigators
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Principal Investigator: Martínez S Antonio, Doctor Staff of the deparment of Anestesiology

Publications of Results:

Other Publications:

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Responsible Party: Clinica Universidad de Navarra, Universidad de Navarra
ClinicalTrials.gov Identifier: NCT02256319     History of Changes
Other Study ID Numbers: DEXPROPAR
First Posted: October 3, 2014    Key Record Dates
Last Update Posted: December 18, 2015
Last Verified: February 2015

Keywords provided by Clinica Universidad de Navarra, Universidad de Navarra:
Deep brain stimulation
Dexmedetomidine
Propofol

Additional relevant MeSH terms:
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Parkinson Disease
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Neurodegenerative Diseases
Dexmedetomidine
Propofol
Hypnotics and Sedatives
Central Nervous System Depressants
Physiological Effects of Drugs
Anesthetics, Intravenous
Anesthetics, General
Anesthetics
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Adrenergic alpha-2 Receptor Agonists
Adrenergic alpha-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action