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

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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03424720
Enrollment
25
Registered
2018-02-07
Start date
2017-08-02
Completion date
2018-10-31
Last updated
2018-02-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

General Anesthesia

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.

Interventions

DEVICEPLE and BIS

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

Sponsors

Hallym University Medical Center
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
20 Years to 65 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
PLE value during induction and emergence of general anesthesiaThrough study completion, an average of fifteen monthsInvestigators 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

MeasureTime frameDescription
BIS value during induction and emergence of general anesthesiaThrough study completion, an average of fifteen monthsInvestigators 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 monitoringThrough study completion, an average of fifteen monthsInvestigators 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 monitoringThrough study completion, an average of fifteen monthsInvestigators 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).

Countries

South Korea

Contacts

Primary ContactKyung Mi Kim, Ph.D.
sumsonyo@hallym.or.kr82313803945

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026