Which is more reliable, BIS value or AEP value in the presence of artifacts during orthognathic surgery?

UMIN ID: UMIN000021895

Registered date:13/04/2016

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Adult patients who are scheduled for orthognathic surgery
• Date of first enrollment: 2016/06/01
• Target sample size: 52
• Countries of recruitment: Japan
• Study type: Interventional
• Intervention(s): Subjects undergo general anesthesia applying both BIS electrodes and AEP electrodes.

Outcome(s)

• Primary Outcome: Comparison of the variability regions of BIS value and AEP value during the operation
• Secondary Outcome: Comparison of BIS value or AEP value with autonomic activity evaluated by heart rate variability Comparison of BIS value and AEP value with serum cortisol level

Key inclusion & exclusion criteria

• Age minimum: 20years-old
• Age maximum: 70years-old
• Gender: Male and Female
• Exclude criteria: ASA PS 3-4 Patients who have a disease of cardiovascular, autonomic nervous, or endocrine system Patients who have a disease associated with auditory nerve, or auditory neural pathway Patients with skin abnormality at ear or forehead Patients who presented positive reaction of Allen test

Related Information

• Primary Sponsor: Kanagawa Dental University
• Source(s) of Monetary Support: Japan Society for the Promotion of Science