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

NCT ID: NCT03424720

Last Updated: 2018-02-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

25 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-08-02

Study Completion Date

2018-10-31

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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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.

Conditions

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General Anesthesia

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Comparison of 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

Group Type EXPERIMENTAL

PLE and BIS

Intervention Type DEVICE

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

Interventions

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PLE 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

Intervention Type DEVICE

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
Minimum Eligible Age

20 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hallym University Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Kyung Mi Kim

Staff, Department of Anesthesiology and pain Medicine, Principal Investigator, Assistant Professor.

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Kyung Mi Kim, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Department of Anesthesiology and Pain Medicine

Locations

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Hallym University Medical Center

Anyang-si, Gyeonggi-do, South Korea

Site Status RECRUITING

Countries

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South Korea

Central Contacts

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Kyung Mi Kim, Ph.D.

Role: CONTACT

82313803945

Facility Contacts

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Kyung Mi Kim, Ph.D.

Role: primary

82313803945

Other Identifiers

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3-2017-10047988

Identifier Type: -

Identifier Source: org_study_id

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