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NCT00588926 Clinical Trial

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

Movement Disorders Clinical Trial

Clinical Trial Details — Status: Active, not recruiting

Administrative data
NCT number NCT00588926
Other study ID # 221107-hmo-ctil
Secondary ID
Status Active, not recruiting
Phase N/A
First received December 30, 2007
Last updated December 30, 2007

Study information
Verified date December 2007
Source Hadassah Medical Organization
Contact n/a
Is FDA regulated No
Health authority Israel: Israeli Health Ministry Pharmaceutical Administration
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Active, not recruiting
Enrollment 20
Est. completion date
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group N/A and older
Eligibility 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 Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Basic Science

Related Conditions & MeSH terms

Intervention

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.

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Hadassah Medical Organization

Outcome
Type Measure Description Time frame Safety issue
Primary Electrical activity in the basal ganglia During the experiment No
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