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Changes of the Neuronal Activity in the Subthalamic Nucleus Under Remifentanil Sedation During Stereotactic Electrode Implantation

Primary Purpose

Movement Disorders, Effect of Remifentanil

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Remifentanil
Sponsored by
Hadassah Medical Organization
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Movement Disorders focused on measuring Deep Brain Stimulation, Movement Disorders, Remifentanil, Sedation, Basal Ganglia electrical activity

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Patients with movement disorder, who are candidates for implantation of deep brain stimulation electrode.

Exclusion Criteria:

  • Suspected difficult intubation
  • history of sleep apnea
  • known allergy for remifentanil

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    A

    Arm Description

    The patients get a period of sedation with remifentanil, before, during and after which, the changes in the electrical activity of the Basal Ganglia is recorded.

    Outcomes

    Primary Outcome Measures

    Electrical activity in the basal ganglia

    Secondary Outcome Measures

    Full Information

    First Posted
    December 30, 2007
    Last Updated
    December 30, 2007
    Sponsor
    Hadassah Medical Organization
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00588926
    Brief Title
    Changes of the Neuronal Activity in the Subthalamic Nucleus Under Remifentanil Sedation During Stereotactic Electrode Implantation
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    December 2007
    Overall Recruitment Status
    Unknown status
    Study Start Date
    undefined (undefined)
    Primary Completion Date
    undefined (undefined)
    Study Completion Date
    undefined (undefined)

    3. Sponsor/Collaborators

    Name of the Sponsor
    Hadassah Medical Organization

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    Deep brain stimulation is commonly used for the treatment of movement disorders. Electrode positioning is usually performed under local anesthesia in fully awake patients. The procedure is uncomfortable to the patients who has to remain motionless during the whole surgery. Previous reports of electrode positioning under general anesthesia was found to be less accurate. This result was probably due to the effect of the anesthetics on the electrical activity of the basal ganglia. The purpose of this study is to detect possible changes in the electrical activity of the basal ganglia related to remifentanil sedation. electrical activity of single neurons will be recorded before, during and after sedation.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Movement Disorders, Effect of Remifentanil
    Keywords
    Deep Brain Stimulation, Movement Disorders, Remifentanil, Sedation, Basal Ganglia electrical activity

    7. Study Design

    Primary Purpose
    Basic Science
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    20 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    A
    Arm Type
    Experimental
    Arm Description
    The patients get a period of sedation with remifentanil, before, during and after which, the changes in the electrical activity of the Basal Ganglia is recorded.
    Intervention Type
    Drug
    Intervention Name(s)
    Remifentanil
    Intervention Description
    After the mapping electrode is in situ, recording of baseline electrical activity is done for two-three minutes and an infusion of Remifentanil, 0.1 microgram per kilogram per minute is started. This procedure continues for a few minutes until the patient is sedated and then the infusion is stopped and the patient allowed to recover. The recordings continue during the whole procedure.
    Primary Outcome Measure Information:
    Title
    Electrical activity in the basal ganglia
    Time Frame
    During the experiment

    10. Eligibility

    Sex
    All
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Patients with movement disorder, who are candidates for implantation of deep brain stimulation electrode. Exclusion Criteria: Suspected difficult intubation history of sleep apnea known allergy for remifentanil
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Dan Eimerl, MD
    Organizational Affiliation
    Hadassah Medical Organization
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    32884017
    Citation
    Benady A, Zadik S, Eimerl D, Heymann S, Bergman H, Israel Z, Raz A. Sedative drugs modulate the neuronal activity in the subthalamic nucleus of parkinsonian patients. Sci Rep. 2020 Sep 3;10(1):14536. doi: 10.1038/s41598-020-71358-3.
    Results Reference
    derived

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    Changes of the Neuronal Activity in the Subthalamic Nucleus Under Remifentanil Sedation During Stereotactic Electrode Implantation

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