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

December 30, 2007 updated by: Hadassah Medical Organization

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

20

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: A
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.
Drug: Remifentanil
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Electrical activity in the basal ganglia
Time Frame: During the experiment
During the experiment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hadassah Medical Organization

Investigators

  • Principal Investigator: Dan Eimerl, MD, Hadassah Medical Organization

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

First Submitted

December 30, 2007

First Submitted That Met QC Criteria

December 30, 2007

First Posted (Estimate)

January 9, 2008

Study Record Updates

Last Update Posted (Estimate)

January 9, 2008

Last Update Submitted That Met QC Criteria

December 30, 2007

Last Verified

December 1, 2007

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 221107-hmo-ctil

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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