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

NCT00588926 | Unknown

• 1 other identifier: 221107-hmo-ctil
• Study Type: interventional
• Target: 20
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Movement Disorders; Effect of Remifentanil

Keywords

Deep Brain Stimulation; Movement Disorders; Remifentanil; Sedation; Basal Ganglia electrical activity

Outcome Measures

Primary Outcomes (1)

• Electrical activity in the basal ganglia

  During the experiment

Study Arms (1)

A

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.

Drug: Remifentanil

Interventions

Remifentanil DRUG

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.

A

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with movement disorder, who are candidates for implantation of deep brain stimulation electrode.

You may not qualify if:

• Suspected difficult intubation
• history of sleep apnea
• known allergy for remifentanil

Sponsors & Collaborators

• Hadassah Medical Organization: lead

Related Publications (1)

• Benady A, Zadik S, Eimerl D, Heymann S, Bergman H, Israel Z, Raz A. Sedative drugs modulate the neuronal activity in the subthalamic nucleus of parkinsonian patients. Sci Rep. 2020 Sep 3;10(1):14536. doi: 10.1038/s41598-020-71358-3.

  PMID: 32884017 DERIVED

MeSH Terms

Conditions

Movement Disorders

Interventions

Remifentanil

Condition Hierarchy (Ancestors)

Central Nervous System Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Propionates; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Dan Eimerl, MD

  Hadassah Medical Organization

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: December 30, 2007
• First Posted: January 9, 2008
• Last Updated: January 9, 2008

Record last verified: 2007-12