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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified December 2007 by Hadassah Medical Organization.
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
Hadassah Medical Organization
ClinicalTrials.gov Identifier:
NCT00588926
First received: December 30, 2007
Last updated: NA
Last verified: December 2007
History: No changes posted
  Purpose

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 Intervention
Movement Disorders
Effect of Remifentanil
Drug: Remifentanil

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Basic Science

Resource links provided by NLM:


Further study details as provided by Hadassah Medical Organization:

Primary Outcome Measures:
  • Electrical activity in the basal ganglia [ Time Frame: During the experiment ] [ Designated as safety issue: No ]

Enrollment: 20
Arms Assigned Interventions
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.

  Eligibility

Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00588926

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

No publications provided

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
Study First Received: December 30, 2007
Last Updated: December 30, 2007
Health Authority: Israel: Israeli Health Ministry Pharmaceutical Administration

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
Analgesics, Opioid
Anesthetics
Anesthetics, General
Anesthetics, Intravenous
Central Nervous System Agents
Central Nervous System Depressants
Hypnotics and Sedatives
Narcotics
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Sensory System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on November 20, 2014