Differential Effects of Propofol on Scalp and Intracranial EEG

General Anesthesia Clinical Trial

Official title:

Differential Effects of Propofol on Scalp and Intracranial Electroencephalogram

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02995447
• Other study ID #: EPI_12
• Status: Recruiting
• Phase: N/A
• First received: October 3, 2014
• Last updated: December 4, 2017
• Start date: November 2012
• Est. completion date: December 2018

Study information

• Verified date: December 2017
• Source: University Hospital, Bonn
• Contact: Martin Soehle, MD, PhD
• Phone: ++49-228-287-
• Email: martin.soehle[@]ukb.uni-bonn.de
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The anesthetic propofol has a dose-depending effect on the EEG, which differs in comparison between scalp and intracerebral electrodes

Description:

The electrical activity of the brain (electroencephalogram EEG) is usually assessed from the surface of the head, which is approximately 1-2 cm above the cerebral cortex. Thus, the spatial resolution of the EEG is low, and the electrical activity recorded originates from a multitude of neurons.

Deep brain structures such as the hippocampus also generate electrical activity which cannot be assessed from the surface of the head. However, in some patients electrodes are implanted into the brain to look for the origin of epileptic seizures. Along the way, these intracerebral electrodes enable to record the EEG from intracerebral structures which are generated from few neurons only. Once the origin of epilepsy has been identified, the intracerebral electrodes are removed under general anesthesia.

Anesthetics such as propofol characteristically modify the EEG in a dose-dependant manner. More over, the propofol effect on the EEG recorded from the surface is likely to be different from the intracerebral EEG, however little is known so far. Therefore we aim to investigate the differential effect of propofol on the superficial versus intracerebral recorded EEG.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 15
• Est. completion date: December 2018
• Est. primary completion date: October 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Patients with implanted intracerebral EEG electrodes

Exclusion Criteria:

• Pregnancy

Related Conditions & MeSH terms

• General Anesthesia

Intervention

Other:
• differences between surface and intracerebral EEG
No intervention is performed. Im- and explantation of intracerebral electrodes is performed for clinical and not for study purposes. The only difference between study and non-study patients is that the surface as well as the intracerebral EEG is recorded and stored in the former, while it is discarded in the latter.

Locations

Country	Name	City	State
Germany	Dept. of Anaesthesiology and Intensive Care Medicine, University of Bonn	Bonn

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Bonn

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	EEG amplitude	EEG amplitude in comparison between scalp and intracranial recordings	up to two hours of EEG recording
Primary	EEG frequency spectrum	EEG frequency spectrum in comparison between scalp and intracranial recordings	up to two hours of EEG recording
Secondary	EEG Burst Suppression Ratio	EEG Burst Suppression Ratio in comparison between scalp and intracranial recordings	up to two hours of EEG recording