SEP Changes During Deep Anesthesia

Somatosensory Evoked Potentials, and Electroencephalography Clinical Trial

— SEPinBSP  

Official title:

The Effect of Burst-suppression-pattern in EEG on Generating Somatosensory Evoked Potentials

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02394002
• Other study ID #: 2013071151
• Status: Recruiting
• Phase: N/A
• First received: March 16, 2015
• Last updated: March 19, 2015
• Start date: March 2015
• Est. completion date: March 2017

Study information

• Verified date: March 2015
• Source: Heinrich-Heine University, Duesseldorf
• Contact: Andrea Szelényi, Prof.
• Phone: +49 211 8117646
• Email: andrea.szelenyi[@]uni-duesseldorf.de
• Is FDA regulated: No
• Health authority: Germany: Ethics Commission, Heinrich Heine University, Duesseldorf
• Study type: Interventional

Clinical Trial Summary

The relation between burst and suppression periods in transcranial and direct cortical recorded EEG with cortical amplitudes median nerve somatosensory evoked potentials is studied.

60 patients are included in this study: 15 patients undergoing brain tumor surgery, 15 spine surgery (University Hospital Düsseldorf) and 30 patients during general surgical procedures (Helios Klinikum Wuppertal).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: March 2017
• Est. primary completion date: March 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Location Helios Klinikum Wuppertal: neurological healthy patients, which undergo an elective surgery under general anaesthesia

• Location Department of Neurosurgery, University Hospital Düsseldorf: all patients with intracranial interventions and the possibility to place a stripe electrode without complications on cortex (it is decided by the surgeon while surgery because of the situs and tumorlocation)

Exclusion Criteria:

• periodical consumption of drugs and pharmaceuticals which influence cortical excitability

• intraoperative contraindication for required depth of anaesthesia

• neurological pre-existing illness

• advanced hepatic insufficiency

Study Design

Allocation: Non-Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Somatosensory Evoked Potentials, and Electroencephalography

Intervention

Drug:
• Propofol

Locations

Country	Name	City	State
Germany	Neurosurgical Clinic	Duesseldorf

Sponsors (3)

Lead Sponsor	Collaborator
Andrea Szelenyi	Department of Anaesthesiology, Heinrich Heine University, Department of Anesthesiology, Helios Klinikukm Wuppertal

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	SEP ampiltude in burst-suppression-EEG		2 hours	No