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

NCT ID: NCT00588926

Last Updated: 2008-01-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Brief Summary

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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.

Detailed Description

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Conditions

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Movement Disorders Effect of Remifentanil

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

Remifentanil

Intervention Type 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.

Interventions

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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.

Intervention Type DRUG

Eligibility Criteria

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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
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hadassah Medical Organization

OTHER

Sponsor Role lead

Responsible Party

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Dept. Anesthesiology, Hadassah Medical Center, Jerusalem, Israel.

Principal Investigators

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Dan Eimerl, MD

Role: PRINCIPAL_INVESTIGATOR

Hadassah Medical Organization

References

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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.

Reference Type DERIVED
PMID: 32884017 (View on PubMed)

Other Identifiers

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221107-hmo-ctil

Identifier Type: -

Identifier Source: org_study_id

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