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Effects of Dexmedetomidine on Activity in the Subthalamic Nucleus

NCT ID: NCT01721460

Last Updated: 2017-12-08

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

6 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-11-30

Study Completion Date

2015-06-30

Brief Summary

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The purpose of this research study is to find out whether dexmedetomidine changes brain cell activity in the subthalamic nucleus (STN).

Detailed Description

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In order to find whether dexmedetomidine is optimal for sedation during Deep brain stimulation surgery, we will measure the electrical activity in the STN during Deep brain stimulation surgery, and measure how this activity is changed during administration of Dexmedetomidine. We hypothesize that dexmedetomidine does not change the firing rate and pattern in the STN.

Conditions

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Parkinson's Disease Deep Brain Stimulation Surgery

Keywords

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SubThalamic Nucleus Microelectrode recording Deep Brain Stimulation Electrode implantation

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Dexmedetomidine during MER

The study is performed in patients undergoing DBS electrode implantation to their STN for the treatment of parkinson's disease. Microelectrode recording (MER) is performed as part of STN electrode implantation surgery, to increase the precision of the stimulating electrode placement. The study includes administration of dexmedetomidine while recording electrical activity at a single location to evaluate the effects of this drug on the MER.

Group Type EXPERIMENTAL

Dexmedetomidine

Intervention Type DRUG

Dexmedetomidine infusion will be started with a loading dose of 1 mcg/Kg over ten to 20 minutes followed by a maintenance infusion of 0.7 mcg/Kg/hr until stable sedation is achieved.

Interventions

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Dexmedetomidine

Dexmedetomidine infusion will be started with a loading dose of 1 mcg/Kg over ten to 20 minutes followed by a maintenance infusion of 0.7 mcg/Kg/hr until stable sedation is achieved.

Intervention Type DRUG

Other Intervention Names

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Precedex

Eligibility Criteria

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Inclusion Criteria

* Patients scheduled to undergo bilateral STN electrode implantation surgery with Micro-electrode recording for the treatment of Parkinson's disease.

Exclusion Criteria

* Hypersensitivity to dexmedetomidine
* Bradycardia: Sinus rhythm slower than 50 bpm
* Known or suspected obstructive sleep apnea
* Suspected difficult intubation
* Pregnancy
* Under 18 years of age or over 85 years of age
* Cognitive disability impairing understanding the experiment or signing the informed consent form
Minimum Eligible Age

18 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Wisconsin, Madison

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Aeyal Raz, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Wisconsin, Madison, Department of anesthesiology

Locations

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University of Wisconsin - Madison, School of Medicine and Public Health

Madison, Wisconsin, United States

Site Status

Countries

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United States

References

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Amlong C, Rusy D, Sanders RD, Lake W, Raz A. Dexmedetomidine depresses neuronal activity in the subthalamic nucleus during deep brain stimulation electrode implantation surgery. BJA Open. 2022 Sep 9;3:100088. doi: 10.1016/j.bjao.2022.100088. eCollection 2022 Sep.

Reference Type DERIVED
PMID: 37588575 (View on PubMed)

Other Identifiers

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2012-0400

Identifier Type: -

Identifier Source: org_study_id