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

Loma Linda University (LLU) logo

Loma Linda University (LLU)

Status

Completed

Conditions

Craniotomy
Transphenoidal Pituitary Resection

Study type

Observational

Funder types

Other

Identifiers

NCT01256749
5100294

Details and patient eligibility

About

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.

Enrollment

31 patients

Sex

All

Ages

18 to 90 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

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

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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