Deep Brain Stimulation (DBS) Sedation

NCT03283150 | Terminated Phase 4 Results DMC FDA Drug

• 4 other identifiers: 2016-1420A530900SMPH\ANESTHESIOLOGY\ANESTHESIOProtocol Version 2/17/2020
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

Deep brain stimulation (DBS) of different brain nuclei is a treatment for multiple brain disorders. The subthalamic nucleus (STN) and globus pallidus have been used to treat advanced Parkinson's disease for a long time. The ventral intermediate nucleus of the thalamus is an effective target for treating essential tremor patients. STN and the internal segment of the globus pallidus are useful targets for treating dystonia. To achieve this optimal electrode localization, many centers perform electrophysiological mapping of the target nuclei using microelectrode recording (MER). This way they can achieve precise localization of the electrode. During the mapping procedure, microelectrodes are passed through the target nuclei, and the electrical neuronal activity is observed and recorded. The surgical team can identify the precise location of the target nuclei and its borders according to the typical activity of its neurons. This study will compare the activity of neurons in several DBS targets before, during and after sedation with propofol, remifentanil and dexmedetomidine. The goal is to understand the effects of anesthetics on the neuronal activity in these targets, allowing us to choose the most appropriate sedation protocol to use during implantation of DBS electrodes in deep brain structures (bearing in mind that each structure may have a different optimal protocol).

Conditions

Brain; Sedation

Keywords

Deep Brain Stimulation(DBS); Sedation; DBS Implantation; Microelectrode recording(MER)

Outcome Measures

Primary Outcomes (1)

• Sedatives Drugs Effects - Percent Change in Root Mean Square (RMS) of Electrical Activity

  Effects of propofol, remifentanil and dexmedetomidine on the neuronal activity during microelectrode recording (MER) in different brain structures that are used as target for DBS implantation will be measure. The RMS of the electrical activity as a measure of the spiking rate of neurons in the vicinity of the electrode tip. normalize the RMS to the baseline value recorded at the first 2-5 minutes of MER (before entering the target area) to compensate for differences between patients and recording electrodes. In order to calculate the change in the normalized RMS following sedation the investigators will compare the mean RMS during 2 minutes of the stable recording of the pre-sedation baseline to the mean RMS during stable sedation and following recovery.

  45 minutes

Secondary Outcomes (2)

• Mean Time in Minutes From Sedation to Recovery

  up to 57 minutes

• Number of Individuals Examined for Neuronal Activity Changes at Multiple Brain Regions Under the Effect of Different Sedative Drugs

  1hrs 30 min

Study Arms (3)

Remifentanil

ACTIVE COMPARATOR

Remifentanil will be administered to subjects during microelectrode recordings (MER).

Drug: Remifentanil

Propofol

ACTIVE COMPARATOR

Propofol will be administered to subjects during MER.

Drug: Propofol

Dexmedetomidine

ACTIVE COMPARATOR

Dexmedetomidine will be administered to subjects during MER.

Drug: Dexmedetomidine

Interventions

Remifentanil DRUG

Remifentanyl will be administered for 10 -15 minutes before initiating the MER phase and the patient will be allow to wake up and the bispectral index (BIS) values to normalize to awake level for the MER.

Remifentanil

Propofol DRUG

Propofol will be administered for 10 -15 minutes before initiating the MER phase and the patient will be allow to wake up and the BIS values to normalize to awake level for the MER.

Propofol

Dexmedetomidine DRUG

Dexmedetomidine will be administered for 10 -15 minutes before initiating the MER phase and the patient will be allow to wake up and the BIS values to normalize to awake level for the MER.

Dexmedetomidine

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may not qualify if:

• Known or suspected obstructive sleep apnea.
• Suspected difficult intubation.
• Pregnancy (pregnancy test is standard care for women of childbearing age)
• Under 18 years of age or over 85 years of age
• Cognitive disability impairing understanding the experiment or signing the informed consent form.

Sponsors & Collaborators

• University of Wisconsin, Madison: lead

Study Sites (1)

University of Wisconsin Hospital and Clinics

Madison, Wisconsin, 53705, United States

Location

Related Publications (1)

• Raz A, Eimerl D, Zaidel A, Bergman H, Israel Z. Propofol decreases neuronal population spiking activity in the subthalamic nucleus of Parkinsonian patients. Anesth Analg. 2010 Nov;111(5):1285-9. doi: 10.1213/ANE.0b013e3181f565f2. Epub 2010 Sep 14.

  PMID: 20841416 BACKGROUND

MeSH Terms

Interventions

Remifentanil; Propofol; Dexmedetomidine

Intervention Hierarchy (Ancestors)

Propionates; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Imidazoles; Azoles

Results Point of Contact

• Title: Jeremy Sullivan
• Organization: University of Wisconsin-Madison

jasullivan@wisc.edu

6082639976

Study Officials

• Corey A Amlong, MD

  University of Wisconsin, Madison

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 6, 2017
• First Posted: September 14, 2017
• Study Start: December 1, 2017
• Primary Completion: January 20, 2022
• Study Completion: January 20, 2022
• Last Updated: July 5, 2024
• Results First Posted: March 27, 2023

Record last verified: 2024-06

Locations

US (1)