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

Not Applicable

• Conditions: General Anesthesia
• Interventions: Device: PLE and BIS

• Registration Number: NCT03424720
• Lead Sponsor: Hallym University Medical Center

Brief Summary

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

Detailed Description

1. 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.

2. 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.

Study Timeline

• Study Start: 2017-08-02
• Study First Submitted: 2018-01-17
• Status Verified: 2018-02
• Study First Submitted QC: 2018-02-05
• Last Update Submitted: 2018-02-05
• Study First Posted: 2018-02-07
• Last Update Posted: 2018-02-07
• Primary Completion: 2018-10-31
• Study Completion: 2018-10-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 25

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Comparison of PLE and BIS	PLE and BIS	Investigators assess PLE and BIS values as indicators of the depth of anesthesia during induction and emergence of anesthesia and facial nerve integrity monitoring

Primary Outcome Measures

Name	Time	Method
PLE value during induction and emergence of general anesthesia	Through study completion, an average of fifteen months	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).

Secondary Outcome Measures

Name	Time	Method
BIS value during induction and emergence of general anesthesia	Through study completion, an average of fifteen months	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).
PLE value during facial nerve integrity monitoring	Through study completion, an average of fifteen months	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).
BIS value during facial nerve integrity monitoring	Through study completion, an average of fifteen months	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).

Trial Locations

Locations (1)

Hallym University Medical Center; 🇰🇷 Anyang-si, Gyeonggi-do, Korea, Republic of