Comparative Analysis of Phase Lag Entropy (PLE) and Bispectral Index (BIS) as an Anesthetic Depth Indicator

Study Overview
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Brief Summary
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The aim of this comparative analysis is to evaluate the reliability of PLE value as an anesthetic depth indicator

Detailed Description
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To evaluate the reliability of PLE value as an anesthetic depth indicator, the investigators compare PLE value with BIS score during induction and emergence of general anesthesia using propofol target controlled infusion. In addition, the investigators verify whether or not the facial nerve integrity monitoring affects the efficacy for PLE and BIS values as an anesthetic depth indicator.

Official Title
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Comparative Analysis of Phase Lag Entropy (PLE) and Bispectral Index (BIS) as an Anesthetic Depth Indicator in Patients Undergoing Otopharyngeal Surgery With Facial Nerve Integrity Monitoring

Conditions
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General Anesthesia

Intervention / Treatment
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* Device: PLE and BIS


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients who scheduled for otopharyngeal surgery under facial nerve integrity monitoring requiring general anesthesia and American Society of Anesthesiology (ASA) physical status 1 or 2 Exclusion Criteria: Patient who has been taken anticonvulsant agents, sedatives, and hypnotics Patient who has central nerve system disease, neurological disorder Patient with hypersensitivity to anesthetics

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Comparison of PLE and BIS<br>Investigators assess PLE and BIS values as indicators of the depth of anesthesia during induction and emergence of anesthesia and facial nerve integrity monitoring | Device: PLE and BIS<br>* Investigators attach the PLE and BIS sensors on the forehead of the patients undergoing facial nerve integrity monitoring during general anesthesia using total intravenous anesthetics<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| PLE value during induction and emergence of general anesthesia | Investigators measure the PLE value as an anesthetic depth indicator before the injection of propofol, at the time point of no response to verbal command, before and after intubation, and at the time point of response to verbal command during emergence of anesthesia. The PLE value will be reported in a score ranging from 0 (burst suppression or deep sedated) to 100 (full awake). | Through study completion, an average of fifteen months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| BIS value during induction and emergence of general anesthesia | Investigators measure the BIS value as an anesthetic depth indicator before the injection of propofol, at the time point of no response to verbal command, before and after intubation, and at the time point of response to verbal command during emergence of anesthesia. The BIS value will be reported in a score ranging from 0 (burst suppression or deep sedated) to 100 (full awake). | Through study completion, an average of fifteen months | 
| PLE value during facial nerve integrity monitoring | Investigators measure the PLE value at the time points of facial nerve integrity monitoring. The PLE value will be reported in a score ranging from 0 (burst suppression or deep sedated) to 100 (full awake). | Through study completion, an average of fifteen months | 
| BIS value during facial nerve integrity monitoring | Investigators measure the BIS value at the time points of facial nerve integrity monitoring. The BIS value will be reported in a score ranging from 0 (burst suppression or deep sedated) to 100 (full awake). | Through study completion, an average of fifteen months |