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

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ClinicalTrials.gov Identifier: NCT00588926
Recruitment Status : Unknown
Verified December 2007 by Hadassah Medical Organization.
Recruitment status was:  Active, not recruiting
First Posted : January 9, 2008
Last Update Posted : January 9, 2008
Sponsor:
Information provided by:

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.


Condition or disease Intervention/treatment
Movement Disorders Effect of Remifentanil Drug: Remifentanil

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 20 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science

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U.S. FDA Resources

Arms and Interventions

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.


Outcome Measures

Primary Outcome Measures :
  1. Electrical activity in the basal ganglia [ Time Frame: During the experiment ]

Eligibility Criteria

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00588926


Sponsors and Collaborators
Hadassah Medical Organization
Investigators
Principal Investigator: Dan Eimerl, MD Hadassah Medical Organization
More Information

Responsible Party: Dr. Dan Eimerl, M.D., Dept. Anesthesiology, Hadassah Medical Center, Jerusalem, Israel.
ClinicalTrials.gov Identifier: NCT00588926     History of Changes
Other Study ID Numbers: 221107-hmo-ctil
First Posted: January 9, 2008    Key Record Dates
Last Update Posted: January 9, 2008
Last Verified: December 2007

Keywords provided by Hadassah Medical Organization:
Deep Brain Stimulation
Movement Disorders
Remifentanil
Sedation
Basal Ganglia electrical activity

Additional relevant MeSH terms:
Movement Disorders
Central Nervous System Diseases
Nervous System Diseases
Remifentanil
Analgesics, Opioid
Narcotics
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Hypnotics and Sedatives
Anesthetics, Intravenous
Anesthetics, General
Anesthetics