NCT02995447

Brief Summary

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
15

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Nov 2012

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2012

Completed
1.9 years until next milestone

First Submitted

Initial submission to the registry

October 3, 2014

Completed
2.2 years until next milestone

First Posted

Study publicly available on registry

December 16, 2016

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2018

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2018

Completed
Last Updated

December 5, 2017

Status Verified

December 1, 2017

Enrollment Period

5.9 years

First QC Date

October 3, 2014

Last Update Submit

December 4, 2017

Conditions

General Anesthesia

Keywords

propofolelectroencephalogram

Outcome Measures

Primary Outcomes (2)

  • EEG amplitude

    EEG amplitude in comparison between scalp and intracranial recordings

    up to two hours of EEG recording

  • EEG frequency spectrum

    EEG frequency spectrum in comparison between scalp and intracranial recordings

    up to two hours of EEG recording

Secondary Outcomes (1)

  • EEG Burst Suppression Ratio

    up to two hours of EEG recording

Study Arms (1)

epilepsy patients

The group consists of patients with therapy refractory epilepsy, in which intracerebral electrodes were implanted to locate the seizure origin and to determine whether the patients are eligible for epilepsy surgery. In an observational study, differences between surface and intracerebral EEG are recorded.

Other: differences between surface and intracerebral EEG

Interventions

differences between surface and intracerebral EEGOTHER

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.

epilepsy patients

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients suffering from epilepsy

You may qualify if:

  • Patients with implanted intracerebral EEG electrodes

You may not qualify if:

  • Pregnancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Dept. of Anaesthesiology and Intensive Care Medicine, University of Bonn

Bonn, 53105, Germany

RECRUITING

Study Officials

  • Martin Soehle, MD, PhD

    Dept. of Anesthesiology and Intensive Care Medicine

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Martin Soehle, MD, PhD

CONTACT

++49-228-287-martin.soehle@ukb.uni-bonn.de

Florian Mormann, MD, PhD

CONTACT

++49-228-287-Florian.Mormann@ukb.uni-bonn.de

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Consultant

Study Record Dates

First Submitted

October 3, 2014

First Posted

December 16, 2016

Study Start

November 1, 2012

Primary Completion

October 1, 2018

Study Completion

December 1, 2018

Last Updated

December 5, 2017

Record last verified: 2017-12

Data Sharing

IPD Sharing
Will not share

Locations

DE(1)