Clinical Trial Results:
Effect of dexmedetomidine vs propofol on basal ganglia activity (local field potentials) recorded through implanted stimulators
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Summary
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EudraCT number |
2014-000868-17 |
Trial protocol |
ES |
Global end of trial date |
18 Dec 2015
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Results information
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Results version number |
v1(current) |
This version publication date |
24 Nov 2021
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First version publication date |
24 Nov 2021
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Other versions |
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Trial Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information
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Trial identification
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Sponsor protocol code |
DEXPROPAR
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Additional study identifiers
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ISRCTN number |
- | ||
US NCT number |
NCT02256319 | ||
WHO universal trial number (UTN) |
- | ||
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Sponsors
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Sponsor organisation name |
Clinica Universidad de Navarra
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Sponsor organisation address |
AVENIDA PÍO XII, Nº 36, PAMPLONA/IRUÑA, Spain, 31008
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Public contact |
UCICEC, Clinica Universidad de Navarra, 34 948 255 400, ucicec@unav.es
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Scientific contact |
UCICEC, Clinica Universidad de Navarra, 34 948 255 400, ucicec@unav.es
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Paediatric regulatory details
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Is trial part of an agreed paediatric investigation plan (PIP) |
No
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Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial? |
No
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Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial? |
No
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Results analysis stage
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Analysis stage |
Final
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Date of interim/final analysis |
16 Nov 2016
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Is this the analysis of the primary completion data? |
Yes
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Primary completion date |
18 Dec 2015
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Global end of trial reached? |
Yes
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Global end of trial date |
18 Dec 2015
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Was the trial ended prematurely? |
No
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General information about the trial
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Main objective of the trial |
Study whether there are changes (and their characteristics) in local field potentials recordings in deep subcortical structures, obtained through the stimulators implanted to treat Parkinson's disease, with the administration of dexmedetomidine and propofol.
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Protection of trial subjects |
NA
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Background therapy |
- | ||
Evidence for comparator |
- | ||
Actual start date of recruitment |
01 Oct 2014
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Long term follow-up planned |
No
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Independent data monitoring committee (IDMC) involvement? |
No
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Population of trial subjects
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Number of subjects enrolled per country |
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Country: Number of subjects enrolled |
Spain: 12
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Worldwide total number of subjects |
12
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EEA total number of subjects |
12
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Number of subjects enrolled per age group |
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In utero |
0
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Preterm newborn - gestational age < 37 wk |
0
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Newborns (0-27 days) |
0
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Infants and toddlers (28 days-23 months) |
0
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Children (2-11 years) |
0
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Adolescents (12-17 years) |
0
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Adults (18-64 years) |
8
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From 65 to 84 years |
4
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85 years and over |
0
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Recruitment
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Recruitment details |
12 patiens, 18 Years and older. | ||||||||||
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Pre-assignment
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Screening details |
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. | ||||||||||
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Period 1
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Period 1 title |
Treatment period (overall period)
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Is this the baseline period? |
Yes | ||||||||||
Allocation method |
Non-randomised - controlled
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Blinding used |
Not blinded | ||||||||||
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Arms
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Arm title
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Treatment | ||||||||||
Arm description |
Experimental: Dexmedetomidine recording Recording registered through the deep brain stimulation electrodes with dexmedetomidine at 0.2 μg/kg/h. Intervention: Drug: Dexmedetomidine 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. Intervention: Drug: Propofol No Intervention: Basal recording Recording registered through the deep brain stimulation electrodes with no sedation . | ||||||||||
Arm type |
Experimental | ||||||||||
Investigational medicinal product name |
DEXMEDETOMIDINE
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Investigational medicinal product code |
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Other name |
(S)-4-[1-(2,3-Dimethylphenyl)ethyl]-3H-imidazole
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Pharmaceutical forms |
Concentrate for solution for infusion
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Routes of administration |
Intravenous use
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Dosage and administration details |
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.
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Investigational medicinal product name |
PROPOFOL-LIPURO
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Investigational medicinal product code |
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Other name |
2,6-diisopropylphenol
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Pharmaceutical forms |
Emulsion for emulsion for injection
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Routes of administration |
Intravenous use
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Dosage and administration details |
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.
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Baseline characteristics reporting groups
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Reporting group title |
Treatment period
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Reporting group description |
A total of 12 patients with PD were invited to participate in this study. The participation rate was 100%. One patient was excluded due to an intraoperative adverse event. This patient experienced pharyngeal dystonia and developed dyspnea before DBS implantation, leading to a change in the anesthesia from cooperative sedation to general anesthesia. We also excluded from the analyses the unique patient whose target nucleus was GPi. | ||||||||||||||||||||||||||||||||||||||||||||||||||||||
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End points reporting groups
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Reporting group title |
Treatment
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Reporting group description |
Experimental: Dexmedetomidine recording Recording registered through the deep brain stimulation electrodes with dexmedetomidine at 0.2 μg/kg/h. Intervention: Drug: Dexmedetomidine 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. Intervention: Drug: Propofol No Intervention: Basal recording Recording registered through the deep brain stimulation electrodes with no sedation . | ||
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End point title |
Changes in LFP recordings. Propofol [1] | ||||||||||
End point description |
Study whether there are changes (and their characteristics) in local field potentials recordings in deep subcortical structures, obtained through the stimulators implanted to treat Parkinson's disease, with the administration of dexmedetomidine and propofol. Data are shown as the mean difference between baseline and prpofol LFP . There was a significant decline of 12.7% (95% CI, −21.3 to −4.7) in the relative beta power of the local field potentials for each increment in the estimated peak propofol concentrations at the effect site relative to the control recordings.
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End point type |
Primary
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End point timeframe |
Propofol was administered (about 2 hours) one day after the stimulator reading (baseline).
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| Notes [1] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: A significant 12.7% (95% CI, 4.1 to 21.3) decline in the LFPs relative to the control recordings was evident for eachincrement in the estimated peak effect site concentration of propofol (0.5, 1.0, 1.5, 2.0, and 2.5 μg/ml) when all nuclei were analyzed. |
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| No statistical analyses for this end point | |||||||||||
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End point title |
Changes in LFP recordings. Dexmedetomidine [2] | ||||||||
End point description |
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End point type |
Primary
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End point timeframe |
Dexmedetomidine was administered (for about 6 hours), 3-4 days before the stimulator readind.
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| Notes [2] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: Dexmedetomidine administration at 0.2 μg∙kg-1∙h-1 caused minimal changes in the power distribution. Accordingly, no significant difference was observed when comparing the relative beta power of LFPs (RBP-LFPs) between dexmedetomidine and control recordings, with a mean difference in the RBP-LFPs between dexmedetomidine and control recordings of −7.7 (95% CI, −18.9 to 3.8) when all nuclei were analyzed. |
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| No statistical analyses for this end point | |||||||||
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Adverse events information
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Timeframe for reporting adverse events |
In the event that an SAE occurs, it must be notified within 24 hours after having knowledge of the event. Any SAE that occur after the completion of the trial should be reported if the investigator believes the SAE is related to the study treatment.
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Assessment type |
Systematic | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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Dictionary used for adverse event reporting
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Dictionary name |
ND | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Dictionary version |
ND
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Reporting groups
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Reporting group title |
Experimental group
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Reporting group description |
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| Frequency threshold for reporting non-serious adverse events: 1% | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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Substantial protocol amendments (globally) |
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| Were there any global substantial amendments to the protocol? No | |||
Interruptions (globally) |
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| Were there any global interruptions to the trial? No | |||
Limitations and caveats |
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| Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data. | |||
| None reported | |||
