Effects of different concentrations of dexmedetomidine on basal ganglia neuronal activity (local field potentials) in Parkinson's disease.

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2016-002680-34-ES

Enrollment

Registered

2016-08-05

Start date

2016-10-20

Completion date

Unknown

Last updated

2019-01-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Parkinson's disease MedDRA version: 19.0 Level: LLT Classification code 10013113 Term: Disease Parkinson's System Organ Class: 100000004852

Interventions

Trade Name: Dexdor Product Name: Dexdor Pharmaceutical Form: Concentrate for solution for infusion INN or Proposed INN: DEXMEDETOMIDINE CAS Number: 113775-47-6 Other descriptive name: DEXMEDETOMIDINA

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Patients undergoing placement of DBS for PD in two phases. 2. The patient must be of legal age (> 17 years old). 3. The patient or his representative has consented to participate in the study. 4. The patient should, in the investigator's opinion be able to cooperate during the procedure. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 4 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 8

Exclusion criteria

Exclusion criteria: 1. Known liver disease. 2. Pregnant or nursing women. 3. History of hypersensitivity to dexmedetomidine. 4. Heart block (2nd or 3rd degree), without pacemaker. 5. Symptomatic hypotension. 6. Severe stroke or other neurological deficits that may impair adequate cooperation or observation of the study endpoints

Design outcomes

Primary

Measure	Time frame
Main Objective: To study and quantify the possible effect of different doses of dexmedetomidine (0.2-0.6 µg/kg/h) on the local field potentials (deep brain activity) in patients with Parkinson´s disease undergoing deep brain stimulation implantion.;Secondary Objective: 1- To make an observational comparative analysis of possible changes in tremor of the patients between control and different concentrations of dexmedetomidine. 2- To study the relationship between the effect of dexmedetomidine on the LFPs of the basal ganglia and frontal cortical activity (bispectral index©). ;Primary end point(s): Local field potentials (deep brain activity) recording with the deep brain stimulator under different doses of dexmedetomidine.;Timepoint(s) of evaluation of this end point: Before the second surgery phase (implanting of programmable pulse generator and connection to the deep brain stimulator), in “off” medication and without any residual effect of anesthetic drugs, the patient will be transfer to the post-anesthetic care unit for the administration of dexmedetomidine and recording the local field potentials.	—

Measure

Time frame

Main Objective: To study and quantify the possible effect of different doses of dexmedetomidine (0.2-0.6 µg/kg/h) on the local field potentials (deep brain activity) in patients with Parkinson´s disease undergoing deep brain stimulation implantion.;Secondary Objective: 1- To make an observational comparative analysis of possible changes in tremor of the patients between control and different concentrations of dexmedetomidine. 2- To study the relationship between the effect of dexmedetomidine on the LFPs of the basal ganglia and frontal cortical activity (bispectral index©). ;Primary end point(s): Local field potentials (deep brain activity) recording with the deep brain stimulator under different doses of dexmedetomidine.;Timepoint(s) of evaluation of this end point: Before the second surgery phase (implanting of programmable pulse generator and connection to the deep brain stimulator), in “off” medication and without any residual effect of anesthetic drugs, the patient will be transfer to the post-anesthetic care unit for the administration of dexmedetomidine and recording the local field potentials.

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Secondary

Measure	Time frame
Secondary end point(s): • Demographic variables (sex, age, weight, BMI). • Patient diagnosis and duration of PD. • “Basal tremor” score on the UPDRS-III in state "off" before the surgery. • Stimulation target (STN or Gpi). • Type of intervention. • “Control recording” of LFPs (deep brain activity) through the DBS. • “Dexmedetomidine recording” of local field potentials (deep brain activity) at different concentrations of dexmedetomidine through the deep brain stimulation electrode. • “Control tremor” and “dexmedetomidine tremor” score at different concentration. • Frontal cortical activity (bilateral bispectral index). • Adverse events by the administration of dexmedetomidine;Timepoint(s) of evaluation of this end point: At different moments during the study	—

Measure

Time frame

Secondary end point(s): • Demographic variables (sex, age, weight, BMI). • Patient diagnosis and duration of PD. • “Basal tremor” score on the UPDRS-III in state "off" before the surgery. • Stimulation target (STN or Gpi). • Type of intervention. • “Control recording” of LFPs (deep brain activity) through the DBS. • “Dexmedetomidine recording” of local field potentials (deep brain activity) at different concentrations of dexmedetomidine through the deep brain stimulation electrode. • “Control tremor” and “dexmedetomidine tremor” score at different concentration. • Frontal cortical activity (bilateral bispectral index). • Adverse events by the administration of dexmedetomidine;Timepoint(s) of evaluation of this end point: At different moments during the study

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Countries

Spain

Contacts

Public ContactUCEC

Clinica Universidad de Navarra

ucicec@unav.es34948255 4002723

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 15, 2026