A Comparative Study of Global 12 Lead Electroencephalogram to Frontal SedlineTM Electroencephalogram

Completed

Conditions studied: Craniotomy, Transphenoidal Pituitary Resection

In brief

The fundamental reason for comparing the ability of the Frontal Sedline TM Electroencephalogram (PSA EEG) to standard Global 12 Lead Electroencephalogram (EEG) for burst suppression detection is to determine if a less expensive, less invasive and possibly more convenient bifrontal EEG monitor can be effective for evaluation of anesthesia-induced intraoperative burst suppression therapy (IBST) for cerebral protection.

Key facts

Study ID

NCT01256749

Run by

Loma Linda University

People needed

31

Starts

2010-12-01

Expected to finish

2013-11-01

Last updated by the study team

2014-09-09

Who can join

Age: 18 and older, up to 90. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Adult ASA class 1-3 male or female 18-90 years of age;
• scheduled for elective craniotomy in the LLUMC University Hospital, for which the surgeon has requested intraoperative burst suppression therapy;
• capable of understanding and signing informed consent;
• willing to have dual EEG monitoring.

You may not qualify if…

• Age under 18 years;
• emergency or trauma situation requiring craniotomy;
• surgical approach that prohibits placing the SEDLineTM array on the forehead;
• known sensitivity to the adhesives on the SEDLineTM array;
• lack of availability of standard EEG monitoring;
• patients with seizure disorders and refusal of consent.

Where it is running

• Loma Linda University — Loma Linda, California, United States

Full record on ClinicalTrials.gov

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