Overview

This trial is active, not recruiting.

Conditions movement disorders, effect of remifentanil
Treatment remifentanil
Sponsor Hadassah Medical Organization
Trial size 20 participants
Trial identifier NCT00588926, 221107-hmo-ctil

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Intervention model single group assignment
Masking open label
Primary purpose basic science
Arm
(Experimental)
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.
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.

Primary Outcomes

Measure
Electrical activity in the basal ganglia
time frame: During the experiment

Eligibility Criteria

Male or female participants of any age.

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

Additional Information

Principal investigator Dan Eimerl, MD
Trial information was received from ClinicalTrials.gov and was last updated in December 2007.
Information provided to ClinicalTrials.gov by Hadassah Medical Organization.