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

Hallym University Medical Center25 enrolled

Overview

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

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 Type

INTERVENTIONAL

Allocation

Purpose

DIAGNOSTIC

Masking

NONE

Enrollment

Conditions

General Anesthesia

Interventions

PLE and BISDEVICE

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

Eligibility

Sex: ALLMin age: 20 YearsMax age: 65 Years

Medical Language ↔ Plain English

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

Locations (1)

Hallym University Medical Center

Anyang-si, Gyeonggi-do, South Korea

RECRUITING

Outcomes

Primary Outcomes

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).

Time frame: Through study completion, an average of fifteen months

Secondary Outcomes

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).

Time frame: 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).

Time frame: 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).

Time frame: Through study completion, an average of fifteen months

Central Contacts

Kyung Mi Kim, Ph.D.

CONTACT

82313803945 sumsonyo@hallym.or.kr

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.